Download wound care - European Wound Management Association

Volume 15
Number 1
April 2015
Published by
European
Wound Management
Association
TECHNOLOGIES
LEADING TO
CHANGE
WHERE WILL IT TAKE US?
The EWMA Journal
ISSN number: 1609-2759
Volume 15, No 1, April, 2015
The Journal of the European
Wound Management Association
Published twice a year
EWMA
Council
Salla Seppänen
President
Jan Apelqvist
Immediate Past President
Severin Läuchli
President Elect
Editorial Board
Sue Bale, UK, Editor
Salla Seppänen, Finland
Georgina Gethin, Ireland
Martin Koschnick, Germany
Rytis Rimdeika, Lithuania
José Verdú Soriano, Spain
Luc Gryson
Dubravko Huljev
José Verdú Soriano
Sue Bale
Mark Collier
Ann-Mari Fagerdahl
Georgina Gethin
Arkadiusz Jawien
Edward Jude
Treasurer
Secretary
Scientific Recorder
EWMA web site
www.ewma.org
Editorial Office
please contact:
EWMA Secretariat
Nordre Fasanvej 113
2000 Frederiksberg, Denmark
Tel: (+45) 7020 0305
Fax: (+45) 7020 0315
[email protected]
EWMA Journal Editor
Magdalena Annersten Gershater
Layout:
Nils Hartmann
Cover:
Nils Hartmann, Open design/advertising
Gerrolt Jukema
Martin Koschnick
Knut Kröger
Printed by:
Kailow Graphic, Denmark
Copies printed: 9.000
Prices:
The EWMA Journal is distributed
in hard copies to members
as part of their EWMA membership.
EWMA also shares the vision of
an “open access” philosophy,
which means that the journal is
freely available online.
Individual subscription per issue: 7.50€
Libraries and institutions per issue: 25€
The next issue will be published
in October 2015. Prospective material for
publication must be with the
EWMA Secretariat as soon as possible
and no later than June 15th 2015.
The contents of articles and letters in
EWMA Journal do not necessarily reflect
the opinions of the Editors or the
European Wound Management Association.
All scientific articles are peer reviewed by
EWMA Scientific Review Panel.
Copyright of published material
and illustrations is the property of
the European Wound Management
Association. However, provided prior
written consent for their reproduction,
including parallel publishing
(e.g. via repository), obtained from EWMA
via the Editorial Board of the Journal,
and proper acknowledgement,
such permission will normally
be readily granted. Requests to
reproduce material should state
where material is to be published,
and, if it is abstracted, summarised,
or abbreviated, then the proposed
new text should be sent to the
EWMA Journal Editor for final approval.
All issues of EWMA Journal
are CINAHL listed.
2
Alberto Piaggesi
Rytis Rimdeika
Andrea Pokorná
Robert Strohal
COOPERATING ORGANISATIONS’ BOARD
Esther Armans Moreno, AEEVH
Christian Thyse, AFISCeP.be
Massimo Rivolo, AISLeC
Corrado Maria Durante, AIUC
Ana-Maria Iuonut, AMP Romania
Aníbal Justiniano, APTFeridas
Gilbert Hämmerle, AWA
Kirsty Mahoney, AWTVNF
Jan Vandeputte, BEFEWO
Vladislav Hristov, BWA
Els Jonckheere, CNC
Lenka Veverková, CSLR
Mirela Bulic, CWA
Arne Buss, DGfW
Anette Norden, DSFS
Heidi Castrén, FWCS
Rosa Nascimento, GAIF
J. Javier Soldevilla, GNEAUPP
Georgios Vasilopoulos, HSWH
Christian Münter, ICW
Aleksandra Kuspelo, LBAA
Susan Knight, LUF
Loreta Pilipaityte, LWMA
Corinne Ward, MASC
Hunyadi János, MSKT
Suzana Nikolovska, MWMA
Linda Primmer, NATVNS
Øystein Karlsen, NIFS
Louk van Doorn, NOVW
Arkadiusz Jawień, PWMA
Sebastian Probst, SAfW (DE)
Maria Iakova, SAfW (FR)
Goran D. Lazovic, SAWMA
Tania Asantos, ELCOS
Jan Stryja
Hubert Vuagnat
Ján Koller, SSPLR
Mária Hok, SEBINKO
F. Xavier Santos Heredero, SEHER
Sylvie Meaume, SFFPC
Susanne Dufva, SSIS
Jozefa Košková, SSOOR
Leonid Rubanov, STW (Belarus)
Guðbjörg Pálsdóttir, SUMS
Cedomir Vucetic, SWHS Serbia
Magnus Löndahl, SWHS Sweden
Tina Chambers, TVS
Jasmina Begić-Rahić, URuBiH
Natalia Vasylenko, UWTO
Barbara E. den Boogert-Ruimschotel, V&VN
Caroline McIntosh, WMAI
Skender Zatriqi, WMAK
Dragica Tomc, WMAS
Mustafa Deveci, WMAT
EWMA JOURNAL SCIENTIFIC REVIEW PANEL
Paulo Jorge Pereira Alves, Portugal
Caroline Amery, UK
Jan Apelqvist, Sweden
Sue Bale, UK
Michelle Briggs, UK
Stephen Britland, UK
Mark Collier, UK
Rose Cooper, UK
Javorka Delic, Serbia
Corrado Durante, Italy
Bulent Erdogan, Turkey
Ann-Mari Fagerdahl, Sweden
Madeleine Flanagan, UK
Milada Franců, Czech Republic
Peter Franks, UK
Francisco P. García-Fernández, Spain
Magdalena Annersten Gershater, Sweden
Georgina Gethin, Ireland
Luc Gryson, Belgium
Marcus Gürgen, Norway
Eskild W. Henneberg, Denmark
Alison Hopkins, UK
Gabriela Hösl, Austria
Dubravko Huljev, Croatia
Arkadiusz Jawien, Poland
Gerrolt Jukema, Netherlands
Nada Kecelj, Slovenia
Klaus Kirketerp-Møller, Denmark
Zoltán Kökény, Hungary
Martin Koschnick, Germany
Knut Kröger, Germany
Severin Läuchli, Schwitzerland
Maarten J. Lubbers, Netherlands
Sylvie Meaume, France
Zena Moore, Ireland
Christian Münter, Germany
Andrea Nelson, UK
Pedro L. Pancorbo-Hidalgo, Spain
Hugo Partsch, Austria
Patricia Price, UK
Sebastian Probst, Schwitzerland
Elia Ricci, Italy
Rytis Rimdeika, Lithuania
Zbigniew Rybak, Poland
Salla Seppänen, Finland
José Verdú Soriano, Spain
Robert Strohal, Austria
Richard White, UK
Carolyn Wyndham-White, Switzerland
Gerald Zöch, Austria
CREATING TOMORROW’S SOLUTIONS
PURE
SILICONES
MAY 13 – 15, 2015
LONDON, UK
Visit us at Booth 7-30
www.wacker.com/wound-care
SILPURAN® – This pure, biocompatible silicone from Wacker Chemie gives you consistent high quality for
highly efficient manufacturing processes. SILPURAN® provides an optimal wound healing environment and
enables atraumatic wound dressing changes. For less pain, less trauma and more quality of life.
Wacker Chemie AG, München, Germany, Tel. + 49 89 6279 - 0, www.wacker.com/wound-care
Contact: Dajana Westenberg, E-Mail: [email protected]
ALLEVYN Life exceeds
expectations...
Designed for people who
happen to be patients
98%
of clinicians would
recommend
ALLEVYN Life for use
in their practice1
www.allevynlife.com
ALLEVYN Life
Unique Change Indicator
No border coverage –
50% border coverage –
dressing can remain in place
consider changing
with strikethrough masked
dressing
Wound Management
Smith & Nephew
Medical Ltd
101 Hessle Road
Hull HU3 2BN
UK
T +44 (0)1482 225181
F +44 (0)1482 328326
www.smith-nephew.com
Reference
1. Simon D, Bielby A, A structured collaborative approach to
appraise the clinical performance of a new product Wounds UK.
Vol 10. No 3. 2014.
™Trademark of Smith & Nephew © Smith & Nephew January 2015 56428
75% border coverage –
change dressing
6 Editorial
Science, Practice and Education
8 Efficacy of magnetic resonance imaging in deciding the appropriate
surgical margin in diabetic foot osteomyelitis. Fujii M, Armstrong DG,
Terashi H
15 Ex vivo platelet activation with extended duration pulse electric fields
for autologous platelet gel applications - A new, potential clinical
standard for platelet activation and perspectives for a more widespread
adoption and improved wound healing with platelet gels. Neculaes VB,
Torres A, Morton C, Larriera A, Klopman S, Conway K, Garner AL
21 Pressure ulcer reduction: the role of unregistered healthcare support
workers in validation and prevention. Ellis MB, Price J
27 Measuring change in limb volume to evaluate lymphoedema treatment
outcome. Williams AF, Whitaker J
Scientific Communication
35
42
47
54
61
65
71
Emerging targeted technology to address unmet clinical needs
- Implementing a development and adoption strategy. Vowden P
Great opportunities ahead! Don’t miss the boat! Where tech meets
health care. Reig J, Valverde JA, Reig M
A patient-led approach to product innovation in patient education and
wound management. McNichol E, McKay A, Milligan C, Bennett K,
Hulme R, Joy H
European perspectives on biomaterials for health. Donnelly F
An eLearning modular approach to pressure Ulcer prevention and
management: the views of nursing staff. Cameron R, Rodgers A, Welsh
L, McGown K
Major and minor amputation rates: What do they tell us?. Kröger K
Wound risk and prevention in obesity: The role of nutrition
Ballesteros-Pomar MD
25th Conference of the
European Wound Management Association
EWMA 2015
LONDON · UK
13 -15 MAY 2015
WOUND CARE
– SHAPING THE FUTURE
A PATIENT, PROFESSIONAL, PROVIDER
AND PAYER PERSPECTIVE
Cochrane Reviews
77 Abstracts of recent cochrane reviews. Bell-Syer S
EWMA
84 EWMA Journal previous issues and other journals
86 EWMA 2015 Conference in London, UK, José Verdú Soriano
88 Promoting antimicrobial stewardship in wound care
91 eHealth in wound care - overview and key issues to consider
before implementation. Moore Z
93 EWMA news
97 Report from the 6th Pisa International Diabetic Foot Course 2014
Piaggesi A
98 The woundcare kit - a key tool for wound Care in a humanitarian
Environment. Vuagnat H, Comte E
100 Obituary notice
Organisations
101 AWMA news. Asimus M, Andrews J
102 AAWC news. Driver VR
103 Response to the challenges of chronic wound diseases: CTRS’s action
104 ELCOS - Portuguese Wound Society - an innovative approach
Furtado K, Santos T
106 Slovak Wound Healing Society (SSPLR). Koller J
108 Hellenic Society of Wound Healing (HSWH). Koulermou G
109 Conference calendar
110 Cooperating Organisations
WWW.EWMA2015.ORG
WWW.EWMA.ORG
WWW.TVS.ORG.UK
5
Editorial
New technologies improving
wound care?
T
he title of the EWMA 2015 Conference in
London is Wound Care – Shaping the Future:
a Patient, Professional, Provider, and Payer perspective. The conference focuses on the barriers and challenges, as well as the opportunities that decision makers,
clinicians, and patients face in the modern healthcare systems. The demand for efficient and cost-effective use of
resources to optimise wound care is rising as governments
in the European countries race to cut costs, while maintaining quality of care and improving treatment outcomes.
These developments influence all health care stakeholders,
from patient to policy maker, and they demand innovative procedures and practices, as well as interdisciplinary
teamwork and collaboration.
An important part of the equation is the opportunities
posed by the technological advancements made in wound
care and the organisation of care, and the innovations that
lie ahead. Thus, in this issue of the EWMA Journal, we
focus on new technology and methods that drive innovation within wound care.
On page 8, Miki Fujii et al. explore the efficacy of using MRI for deciding the appropriate surgical margin in
diabetic foot osteomyelitis, and on page 15, Vasile Bogdan
Neculaes et al. introduce a newly developed instrumentbased method for ex vivo platelet activation via extendedduration electrical pulses. Both articles deal with a new
application of existing methods or technology, and could
be seen as examples of incremental innovation, which is
defined by building on, and improving current practices.
The different types of innovation, as well as development
and adoption strategy in a health care context, are explored
further in the article by Peter Vowden on page 35. An
example of an innovation process, with the patient as a
pivotal point, is presented in the article by Elaine McNichol on page 47, and Juan Reig provides a look to the
future, outlining perspectives on the possible technological
developments in health care, in his article on page 42.
EWMA AS A DRIVER OF INNOVATION AND
TECHNOLOGICAL DEVELOPMENTS
EWMA continuously works to be on the forefront of
the developments and innovations in wound care, and
does so through a number of initiatives and activities. At
the EWMA 2015 conference in London, European and
6
American key opinion leaders from academia, associations,
and industry will meet for an expert forum to discuss and
share knowledge about present and future developments
in advanced wound care. EWMA is presently also engaged
in several EU directed development projects following the
Commission’s wish to strengthen the collaboration between academia and industry.
As part of EWMA’s advocacy initiatives to actively shape
the eHealth developments within wound care in the EU,
EWMA is a partner in the EU supported United4Health
project (www.united4health.eu). This project aims to support large-scale deployment of eHealth solutions, and a key
task of EWMA within this project is to highlight the role
of healthcare providers in the successful implementation
of eHealth and telemedicine solutions in clinical practice.
As an important part of EWMA’s engagement in United4Health, EWMA has produced a document providing
a structured overview of the key issues related to use of
eHealth applications within wound care. The document
entitled, “eHealth in Wound Care – Overview and Key
Issues to Consider Before Implementation” has been developed in collaboration with the Australian Wound Management Association, and will be published by the Journal of
Woundcare in May 2015. You can read a summary of this
document on page 91.
As another United4Health activity, EWMA will host
a full day symposium on eHealth at the EWMA conference in London, on Friday 15 May. The symposium
programme is introduced on page 92.
WHY TECHNOLOGY?
An important question to ask in relation to the increased
use and rapid developments within wound care technology
and eHealth is who will benefit from the developments?
This is a key focus point for this year’s congress. The patient should be the major beneficiary of new developments, but are we sure that this is always the case? Too
often, we see projects with great potential for improving
the quality of life for patients being ‘turned down’ due to
too few economic benefits for the system. EWMA always
aims to not only be the voice of the wound care professionals and their associations, but also to ensure that our work
focuses on the patient’s best interest as a cardinal point.
Salla Seppänen, EWMA President
Sue Bale, Editor of EWMA Journal
EWMA Journal 2015 vol 15 no 1
Miki Fujii, MD, PhD1
David G. Armstrong, DPM,
MD, PhD2,
Efficacy of magnetic resonance
imaging in deciding the
appropriate surgical margin
in diabetic foot osteomyelitis
ABSTRACT
The best therapy for diabetic foot osteomyelitis (DFO) is controversial. However, identification of the precise localization of DFO is
essential for appropriate treatment.
AIM
To ascertain the efficacy of magnetic resonance imaging (MRI) in the diagnosis of
DFO, and to select the appropriate surgical
margin.
Hiroto Terashi, MD, PhD3
1Department
of Plastic and
Reconstructive
Surgery, Kitaharima
Medical Center, Ono,
Japan
2Southern Arizona Limb
Salvage Alliance, University
of Arizona College of Medicine, Tucson, AZ, USA
3Department
of Plastic and
Reconstructive Surgery,
Kobe University Hospital,
Kobe, Japan
Correspondence to:
[email protected]
Conflicts of interest: None
METHODS
Preoperative MRI findings were compared
with the results of histopathological examinations of resected bones, and the margins
of the resected bones were analysed by histopathology. A total 149 bones from 28 foot
ulcers in 26 patients were examined. All ulcers were classified into 4 types according to
the main etiological factors.
RESULTS
In 14 neuropathic ulcers, all 55 bones, even
those with severe infection, were fully and
accurately diagnosed with the use of MRI. In
14 ischemic ulcers, only 9 of 94 bones evaluated by MRI after revascularization were diagnosed accurately. Of 32 bone margins that
showed bone marrow oedema, 28 healed,
and 4 did not heal, displaying severe infection or ischemia.
CONCLUSIONS
MRI is effective in the diagnosis of neuropathic ulcers, but not as effective in the diagnosis of ischemic ulcers. This study suggested
that the appropriate surgical margin should
be defined in the area of the bone marrow
oedema, but diligence should be exercised
in cases with severe infection or ischemia.
8
INTRODUCTION
The best therapy for diabetic foot osteomyelitis (DFO),
whether primarily medical or primarily surgical, is a subject of contention. Each has its potential advantages and
disadvantages1. Recent guidelines2 have recommended
that the presence and amount of residual dead or infected
bone and soft tissue should determine the duration of
antibiotic therapy. Besides the choice of primary therapy,
identification of the precise localization of DFO is essential
for appropriate treatment.
Guidelines2,3 recommend the use of plain radiographs
as a first-line investigative tool for diagnosing DFO, and
further note that although magnetic resonance imaging
(MRI) has been recognized as the most accurate imaging
modality for detecting DFO, it is not always necessary for
diagnosing or managing DFO. Plain radiographs, however,
show only destruction of bone, and not actual bone infection or inflammation.
We have previously demonstrated the efficacy of MRI
in the diagnosis of DFO in ulcers with different aetiologies 4,5. In the present report, we describe our study of
additional cases, and propose a means of defining the appropriate surgical margin for remission based on MRI and
histopathological findings.
METHODS
First, preoperative MRI findings were compared with the
results of histopathological examination of the resected
bones. Second, bone margins of the resected bones were
analysed by histopathology.
The records of 26 patients with diabetic foot ulcers (20
men and 6 women; mean age, 66.8 years; range, 42−85
years of age) who were suspected of having osteomyelitis
and had undergone surgery from 2008−2014 were examined. All patients had been diagnosed with type 2 diabetes, according to the classification of the World Health
Organization.
The ulcers were classified into 4 types according to the
main aetiological factors: type I, neuropathic ulcers; type
II, ischemic ulcers (critical limb ischemia [CLI]); type III,
neuropathic ulcers with infection; and type IV, ischemic
EWMA Journal 2015 vol 15 no 1
Science, Practice and Education
ulcers with infection4-6. Peripheral neuropathy (PN) was
assessed by touch sensation using the Ipswich touch test7.
Peripheral arterial disease (PAD) was suspected by the absence of pulsation and/or sound from the dorsalis pedis
artery and the posterior tibial artery assessed by Doppler
stethoscope, an ankle-brachial index < 0.9, and skin perfusion pressure < 40 mmHg. Patients with suspected PAD
were evaluated with the use of computed tomographic
angiography, duplex ultrasonography, and angiography.
Infection was assessed by the following: general conditions
such as high fever, chills, or malaise; clinical findings such
as redness, warmth, swelling, or purulent secretions; the
results of laboratory tests. DFO was suspected in patients
with a positive probe-to-bone test, swollen foot, sausage
toe, unexplained high leukocyte count or inflammatory
markers, and plain foot radiographic findings3.
Preoperative MRI was carried out with 1.5 T MR
scanners (3 mm slice thickness, T1-weighted images,
conventional spin echo, repetition time/echo time of 460
ms/13 ms, fat-suppressed T2-weighted images, short-tau
inversion-recovery images, short T1 inversion recovery,
and repetition time/echo time/inversion time of 3,401
ms/80 ms/150 ms). All MRI findings were checked by
M.F and H.T with consensus interpretation. The affected
bone marrow was compared with the adjacent normal fatty
marrow, and low intensity signals on T1-weighted images
and high intensity signals on fat-suppressed T2-weighted
images were attributed to osteomyelitis. Incomplete or
hazy signals or reticulated patterns were attributed to reactive bone marrow oedema. Normal bone marrow signals
were considered indicative of areas clear of disease (8). All
bones were marked according to the presence of osteomyelitis (OM), bone marrow oedema (BME), or normal
bone (N) (Fig. 1).
Surgery after the MRI diagnosis included resection of
Figure 1: MRI diagnosis of case 1, left 2nd toe
b)
b)
C)
a)
a)
b)
c)
c)
b)
c)
a) Osteomyelitis (OM) (T1WI: low intensity, fat-suppressed;
T2WI: high intensity)
b) Bone marrow edema (BME)
(incomplete or hazy signals or reticulated patterns)
c) Normal bone marrow signal (N)
MRI diagnosis:
Distal phalanges (c): Normal bone (N)
Middle phalanges (b, a): bone marrow edema/ osteomyelitis (BME/
OM)
Proximal phalanges (a, b, c): osteomyelitis/bone marrow edema/
normal bone (OM/BME/N)
EWMA Journal 2015 vol 15 no 1
the infected bones and gangrenous tissue, amputation, or
disarticulation. The area of resection was estimated preoperatively (from the MRI findings, blood flow, and area
of soft tissue infection) and confirmed intraoperatively.
A definitive diagnosis was then made from the histopathological examination of 5 mm thick sections of formalinfixed and paraffin-embedded bones stained with haematoxylin and eosin. Only bone marrow oedema or infiltration of inflammatory cells, or both was considered indicative of reactive bone marrow oedema. However, these 2
conditions, together with the presence of osteonecrosis,
granulation tissue, and/or fibrosis, were considered indicative of osteomyelitis (Fig. 2). The diagnosis from the
preoperative MRI findings was compared with the definitive diagnosis from the histopathological findings (Fig. 3).
Bone margins of the resected bones were examined by
histopathology.
Figure 2: Histopathological diagnosis (haematoxylin & eosin
staining, 40×)
Osteomyelitis (OM) Bone marrow edema (BME)
(H&E; 40 )
Bone marrow edema
Inflammatory cells Osteonecrosis
Granulation
Fibrosis
(H&E; 40 )
Bone marrow edema
Inflammatory cells
Informed consent was obtained from each patient, and
the study protocol conformed to the ethical guidelines of
the Declaration of Helsinki as reflected in the approval by
the institution’s human research review committee.
RESULTS
A total of 28 ulcers from 26 patients, including 2 patients
with 2 different types of ulcers each, were classified into
4 types according to the main aetiological factors as follows: type I, neuropathic ulcers (n=3); type II, ischemic
ulcers (n=3); type III, neuropathic ulcers with infection
(n=11); and type IV, ischemic ulcers with infection (n=11)
(Table 1).
The 26 patients underwent a total of 30 MRI examinations before surgery (Table 2). The average interval between the MRI examinations and surgery was 16.7 (range
2−48) days. All ischemic ulcers (type II and type IV) were
revascularised by bypass or endovascular treatment before
surgery. MRI was carried out as follows: 3 examinations
for 3 type I ulcers; 3 before revascularisation for 3 type II
ulcers; 1 after revascularisation for 1 type II ulcers; 11 for
9

Figure 3: Histopathological diagnosis of
case 1, left 2nd toe.
OM
N
BME)
OM)
BME
BME)
N)
N)
BME
Histopathological features of bone marrow
in the resected bones correspond to the
MRI findings.
Table 1. Classification of ulcers OM
Main aetiologic factors Classification* Ulcers (n) Neuropathic ulcers Type I 3** Ischemic ulcers ( CLI ) Type II 3** Neuropathic ulcers Type III 11** ½ (H&E; 40
)
with infection CLI with infection Type IV 11** Total 28** *Terashi H. et al Keio Osteomyelitis
J Med 2011; 6
0:17-­‐21, *
*Two (OM), bone marrow edema
(BME), normal
marrow
(N)
patients, had two types obone
f ulcers each. N different OM
Table Table 1
1. . C
Classification lassification o
of f u
ulcers lcers Table 2. Details of MRI examinations Main aaetiologic etiologic ffactors actors Classification* Classification* Ulcers Ulcers ((n) n) Main Neuropathic u
lcers Type I
3** Neuropathic ulcers Type I 3** Ischemic u
lcers (
C
LI )
Type I
I 3** Ischemic ulcers ( CLI ) Type II 3** Neuropathic u
lcers Type I
II 11** ½ Neuropathic ulcers Type III 11** ½ with i
nfection with infection CLI 11** CLI w
with ith iinfection nfection Type Type IIV V 11** Total 28** Total 28** *Terashi H
. e
t a
l K
eio J
M
ed 2
011; 6
0:17-­‐21, *
*Two *Terashi H. et al Keio J Med 2011; 60:17-­‐21, **Two patients, h
had ad ttwo wo d
different ifferent ttypes ypes o
of f u
ulcers lcers eeach. ach. patients, Type I Type II MRI 3* 4* Pre-­‐revascularization: 3 Post-­‐revascularization: 1 Type III 11 11* Type IV 11 12* Pre-­‐revascularization: 6 Post-­‐revascularization: 6 Total 28 30* Average interval between MRI and surgery: 16.7 days. *One ulcer of Type II (Case 5) underwent both pre-­‐ and post-­‐
revascularization MRI. Table Table 2
2. . D
Details etails o
of f M
MRI RI e
examinations xaminations 11 type III ulcers; and 6 before and 6 after revascularisation
Ulcers MRI MRI post-revascularisation
for
type IV Ulcers ulcers. Pre- and
MRI
Type I
3 3* Type I for 23 patients who
3* underwent
was
done
2
surgeries,
1 for
Type 3 4* Type III I 3 4* Pre-­‐revascularization: Pre-­‐revascularization: 3
3 type II ulcer and 1 for type IV ulcer.
Post-­‐revascularization: Post-­‐revascularization: 1
1 A
total
of
149
bone
specimens
(39
distal
phalanx,
29
Type I
II 11 11* Type III 11 11* Type 11 12* Pre-­‐revascularization: 6
middle
34 metatarsal bone,
Type IIV V phalanx,
11 46 proximal
12* phalanx,
Pre-­‐revascularization: 6 Post-­‐revascularization: 6
and
from 57 toes as follows:
1 cuboid bone were obtained Post-­‐revascularization: 6 Total 28 30* Total 28 from 3 ulcers),
30* type
II (40 bones from 3
type
I (11 bones
Average iinterval b
etween M
RI a
nd ssurgery: 1
d
Average nterval b
etween M
RI a
nd urgery: 16.7 6.7 and
days. ays. ulcers),
typeof III
(44II (bones
from
11
ulcers),
typeost-­‐
IV
*One u
lcer T
ype Case 5
) u
nderwent b
oth p
re-­‐ *One ulcer of Type II (Case 5) underwent both pre-­‐ aand nd p
post-­‐
(54
bones
from
11
ulcers)
(Table
3).
revascularization revascularization M
MRI. RI. Histologic analysis of all bone specimens revealed the
Table Table 3
3: : SSpecification pecification o
of f b
bone one sspecimens pecimens iin n e
each ach u
ulcer lcer ttype ype Ulcers Ulcers (n) Toes ((n) n) (n) Toes Type I
3 4* Type I 3 4* Type I
I 3 12* Type II 3 12* Type I
II 11 19* Type III 11 19* Type I
V 11 22* Type IV 11 22* Total 28 57* Total 28 57* *Four t
oes a
nd a
c
uboid bone one *Four toes and a cuboid b
10
Bones Bones ((n) n) 11 11 40 40 44 44 54 54 149 149 Distal Distal phalanx phalanx ((n) n) 3 3 12 12 13 13 11 11 39 39 Ulcers 3 3 presence
of osteomyelitis, bone marrow oedema, normal
bone, or gangrene. The histopathological features of bone
Table 3: in
Specification of bbones
one specimens in each ype marrow
the resected
corresponded
toulcer the tMRI
findings for ulcers of types I and III in every localisationMiddle (Table 4). Osteomyelitis
was detected in 41 bones,
Ulcers Distal withphalanx (n) specificity
Toes (n) of Bones phalanx (n) (n) a sensitivity
and
100%.(n) In type
II ulcers,
Type I
3 4* 11 3 however, none of the 40 bones was accurately diagnosed 3 Type II because
3 of
unclear
12* or equivocal
40 12 (Table 9 by
MRI
images
Type III 11 19* 44 13 5). Of 40 bones from type II ulcers, 27 showed
dry gan- 7 Type IV 11 22* 54 11 10 grene.
Only28 9 bones
from
type149 IV ulcers
examined
by 29 Total 57* 39 post-revascularisation
*Four toes and a cuboid MRI
bone were accurately diagnosed.
Middle Middle phalanx phalanx (n) (n) 3 3 9 9 7 7 10 10 29 29 Proximal Proximal phalanx phalanx Metatarsal Metatarsal (n) (n) (n) (n) 3 1 3 1 11 8 11 8 14 10 14 10 18 15 18 15 46 34 46 34 Cuboid Cuboid (n) (n) 1 1 1 1 EWMA Journal 2015 vol 15 no 1
Science, Practice and Education
Table 4. MRI and histopathological diagnosis of neuropathic ulcers (Type I; Neuropathic ulcers, Type III; neuropathic ulcers with infection) MRI diagnosis (n) Histopathological diagnosis (n) Type Ulcers(n) Bones(n) Correct Incorrect OM OM/BME OM/BME/N BME I 3 11 11 0 6 4 0 1 III 11 44 44 0 17 12 2 10 Total 14 55 55 0 Osteomyelitis (OM), bone marrow edema (BME), normal bone (N) N 0 3 The other 45 bones still could not be diagnosed because
clinical outcomes of nonsurgical treatments have been
of unclear or equivocal images.
demonstrated with long-term courses of antibiotics2. If
conservative surgery is chosen, the surgeon needs to know
Histopathological analysis revealed osteomyelitis in 27
bones of type IV ulcers, but only 9 bones were correctly
the precise area of osteomyelitis. If medical therapy were
Table 5. MRI nd histopathological diagnosis ischemic ulcers (CLI) chosen, the duration of antibiotic therapy would depend
diagnosed
byapost-revascularisation
MRI,of with
a sensitiv(Type II; CLI, Type IV; CLI with infection) ity
of 29.6%.
on the presence and amount of residual dead or infected
Margins of 49 bones wereGroup examined
by
histopathology
bone2. Besides choosing primary therapy, identification of
A; Pre-­‐revascularization MRI diagnosis (Table
6). Of 37 bone margins of healed ulcers, 9 were
the precise localization of DFO is therefore essential for
MRI d
iagnosis Histopathological diagnosis normal and 28 displayed bone marrow oedema. Of 12
appropriate
treatment.
OM/
OM/ bone margins of unhealed ulcers, 4 showed bone marrow
MRI is a valuable tool for diagnosing osteomyelitis,
Type Ulcers Bones Correct Incorrect* OM BME BME/N OM/G BME BME/N G N oedema
and
II 3** 8 were
33 gangrenous.
0 Of the
33 32
bone
4 margins
0 0 as well as
0 for defining
1 the
1 presence
27 and
0 anatomy of deep
3
with
marrow
the 4 0 soft
displaying
IV bone
5** 14 oedema,
0 28
healed
14 (87.5%)
3 and 5 tissue
1 infections
2 . Its2 efficacy
1 in accurately
0 that
did not heal were from 2 patients with type III ulcers
the extent of DFO of different aetiological types of ulcers
Table 4. MTable Table RI and 44. . hM
M
istopathological RI RI aand nd hhistopathological istopathological diagnosis dodiagnosis oof f nneuropathic europathic ulcers uulcers lcers involving
severe
soft
tissue
infection
and f iagnosis 2neuropathic patients
with
is not
definitively known. Our previous studies4,5 have
Group Post-­‐revascularization MRI iagnosis (Type I; Neuropathic (Type (Type II; ; NNeuropathic europathic ulcers, Type uulcers, lcers, III; nBeuropathic TT; ype ype IIII; II; nneuropathic europathic ulcers with uulcers ilcers nfection) w
wdith ith iinfection) nfection) type
IV ulcers involving severe soft tissue infection and
demonstrated the efficacy of MRI in diagnosing DFO
ischemia.
8 gangrenous
bone
margins
from
of different
aetiological
types
of
ulcers,
showing that for
dMRI diagnosis MRI MRI d(dn) iagnosis iagnosis (Histopathological (n) n) Histopathological Histopathological diagnosis iagnosis iagnosis n) The
MRI iagnosis 2 patients
dHistopathological iagnosis d(dn) ((n) Type type Type Ulcers(n) Type Ulcers(n) Ulcers(n) Bones(n) Bones(n) Bones(n) Correct Correct Correct Incorrect Incorrect OM OM/ OM/BME OM OM OM/BME OM/BME OM/BME/N OM/BME/N OM/BME/N BME I, III),
BME BME N DFO
N N was reliably disOM/
with
II
ulcers could
not be
diagnosed
by MRIIncorrect because
neuropathic
ulcers
(type
I Ulcers I I 3 Bones 3 3 11 11 11 11 11 11 0 OM BME 0 0 6 BME/N tinguishable
6 6 4 OM/G 4 4 0 from
0 0 BME/N 1 bone
0 1 1 oedema
N 0 0 at any location,
Correct Incorrect* BME G ofType severe
ischemia.
reactive
11 III III 7 11 11 44 44 44 7 44 44 0 0 0 0 17 0 17 17 12 12 2 4 2 2 10 2 3 10 10 0 1 3 3 II III 1** 44 0 0 12 in the presence of severe infection.
Total 6** Total Total 14 40 14 14 55 55 55 -­‐ 55 55 0 1 0 0 1 even
0 However, MRI
IV 55 9 6 0 1 0 0 useful in1 diagnosing
Osteomyelitis Osteomyelitis Osteomyelitis b one OM), marrow b-­‐ bone one m
marrow arrow (BME), eedema dema (12 (BME), BME), bone n4 normal ormal ( N) bbone one ( (N) N) not 3 (OM), ((OM), edema 31 normal 1 was
1 ischemic
9 0 ulcers (type II, IV)
DISCUSSION
because
Osteomyelitis (OM), Bone marrow edema (BME), Normal bone (N), Gangrene (G) of insufficient interstitial fluid. Taken together, our
*Because of unclear equivocal MRI findings, **One ulcer of Type II uprevious
nderwent bconclusions
oth pre-­‐ and phave
ost-­‐ been confirmed by additional
Positive
results
haveor been
shown
with
conservative
surgery
vascularization MRI. combined with antibiotics9,10, and additional satisfactory
cases in the present study. 
Table 5. M
RI and istopathological diagnosis dodiagnosis f iagnosis ischemic lcers (CLI) Table Table 55. . h M
M
RI RI aand nd hhistopathological istopathological oof f uiischemic schemic uulcers lcers ((CLI) CLI) (Type II; CLI, Type with infection) (Type (Type III; I; CICV; LI, LI, C TLI Type ype IIV; V; CCLI LI w
with ith iinfection) nfection) Group A; PGroup Group re-­‐revascularization AA; ; PPre-­‐revascularization re-­‐revascularization MRI diagnosis M
MRI RI ddiagnosis iagnosis Histopathological Histopathological iagnosis Histopathological diagnosis ddiagnosis OM/
OM/
OM/ OM/ OM/
OM/ Type Type Bones Ulcers Ulcers Correct Bones Bones Correct Correct Incorrect* OM OM BME/N BME BME BME/N BME/N OM/G BME/N BME BME BME/N BME/N G N N Type Ulcers Incorrect* Incorrect* OM BME OM/G OM/G BME G N G II 3** II II 33 3** 3** 33 33 0 0 0 33 33 4 33 0 4 4 0 0 0 0 0 0 1 0 0 1 1 1 27 1 1 0 27 27 0 0 IV 5** IV IV 14 5** 5** 14 14 0 0 0 14 14 3 14 5 3 3 0 5 5 0 0 1 2 1 1 2 2 2 1 2 2 0 1 1 0 0 MRI MRI MRI ddiagnosis iagnosis diagnosis Group B; PGroup Group ost-­‐revascularization BB; ; PPost-­‐revascularization ost-­‐revascularization MRI diagnosis M
MRI RI ddiagnosis iagnosis Histopathological diagnosis ddiagnosis Histopathological Histopathological iagnosis OM/
OM/ OM/
OM/
OM/ OM/ Type Ulcers Incorrect* Incorrect* OM BME OM/G OM/G BME G N G Type Type Bones Ulcers Ulcers Correct Bones Bones Correct Correct Incorrect* OM OM BME/N BME BME BME/N BME/N OM/G BME/N BME BME BME/N BME/N G N N II 1** II II 1** 1** 7 7 7 0 0 0 7 7 0 7 0 0 0 0 0 0 0 0 0 4 0 0 2 4 4 0 2 2 1 0 0 1 1 IV 6** IV IV 40 6** 6** 40 40 9 9 9 -­‐ 1 -­‐ -­‐ 6 1 1 1 6 6 1 1 0 1 0 0 0 1 1 0 0 0 0 0 0 0 0 -­‐ -­‐ -­‐ 31 31 12 31 4 12 12 1 4 4 1 1 3 1 3 3 1 1 1 9 1 1 0 9 9 0 0 Osteomyelitis Osteomyelitis Osteomyelitis (OM), Bone ((OM), OM), marrow BBone one edema m
marrow arrow (BME), eedema dema Normal ((BME), BME), bone NNormal ormal (N), G
bbone angrene one ((N), N), GG
(G) angrene angrene ((G) G) *Because *Because o*Because f unclear ooof f r uuenclear quivocal RI findings, *f*One ulcer of Type II uoonderwent b
oth pre-­‐ babnd ppost-­‐
nclear oor r eM
equivocal quivocal M
MRI RI findings, indings, ***One *One uulcer lcer f f TType ype III I uunderwent nderwent oth oth pre-­‐ re-­‐ aand nd ppost-­‐
ost-­‐
vascularization MRI. vascularization vascularization M
MRI. RI. EWMA Journal diagnosis MRI MRI MRI ddiagnosis iagnosis 2015 vol 15 no 1
11
Table 6. Histopathological examinations of the bone margin Bone margins (n) Healed ulcers 37 Unhealed ulcers 12 Total 49 Histopathological diagnosis Normal Bone marrow edema Bone marrow edema Gangrene Currently, the appropriate surgical margin for full remission of DFO is not known. In the present study, we examined 49 bone margins by histopathology and demonstrated
that when the bone margin was set in the area of bone
marrow oedema, the chances of cure were high, and that
diligence was essential with cases of severe soft tissue infection or ischemia.
We propose an appropriate surgical strategy based on
MRI and histopathology. In neuropathic ulcers (type I and
III), the localisation of osteomyelitis is identified by MRI
and the surgical margins are determined on the MR images of the bone (in the area of bone marrow oedema), and
the range of soft tissue infection. Because no methods are
currently available for diagnosing the range of soft tissue
infections, it has to be defined, in part, empirically. Type
II ulcers, CLI, are of dry gangrene caused by ischemia, and
preoperative MRI is not effective for diagnosis, therefore
the site of resection has to be determined based on the
sufficiency of blood supply after revascularisation. Type
IV ulcers, CLI with infection, are the most difficult to
treat because of the decision regarding which to carry out
first, revascularisation for ischemia or debridement for
infection.
Except for cases requiring emergency debridement for
infection, we advocate evaluation of osteomyelitis using
MRI after revascularisation and setting of the bone margin
in the area of bone marrow oedema. Thus, the appropriate
surgical margin should be based on not only the range of
osteomyelitis, but also on the range of soft tissue infection
or the sufficiency of blood supply.
Toes in each type(n) I 0 4 0 0 4 II 2 2 0 8 12 III 2 8 2 0 12 IV 5 14 2 0 21 Total 9 28 4 8 49 Our study has several limitations. First, the definitive
diagnosis of DFO requires both histopathological findings
and isolation of bacteria from bone samples2. To show the
localisation of osteomyelitis, we used histopathological
findings in the diagnosis. Second, our bone samples were
from toes, metatarsals, and a cuboid bone. Although the
forefoot is not the only site of diabetic foot ulcers, it is
the most common11. Third, the classification6 chosen for
categorizing ulcers is not universal. Our Kobe classification7, a hybrid of the University of Texas11 and the Wagner classification12, have recently been used in Japan. In
Asia, type 2 diabetes is becoming epidemic, characterized
by rapid rates of increase within a short period, onset at
a relatively young age, and a low body mass index13. A
distinct discipline of podiatric medicine such as that in
United States or Europe is not available in Asia; therefore,
the establishment of a classification system that is more
relevant to Asian populations is necessary.
In conclusion, although the present study comprised a
limited number of patients, we were able to recommend
an appropriate surgical margin and strategy based on MRI
and histopathology. These continuing studies are therefore
aimed at salvaging as much of the diabetic foot as possible.
REFERENCES
1 Lipsky BA. Treating diabetic foot osteomyelitis
primarily with surgery or antibiotics: have we
answered the question? Diabetes Care
2014;37(3):593-5.
5 Fujii M, Armstrong DG, Terashi H. Efficacy of
Magnetic Resonance Imaging in Diagnosing Diabetic
Foot Osteomyelitis in the Presence of Ischemia. J Foot
Ankle Surg 2013;52: 717-23.
2 Lipsky BA, Berendt AR, Cornia PB, Pile JC, Peters EJ,
Armstrong DG et al. Infectious Diseases Society of
America. 2012 Infectious Diseases Society of America
clinical practice guideline for the diagnosis and
treatment of diabetic foot infections. Clin Infect Dis
2012:54:e132-73.
6 Terashi H, Kitano I, Tsuji Y. Total management of
diabetic foot ulcerations-Kobe classification as a new
classification of diabetic foot wounds. Keio J Med
2011;60:17-21.
3 Lipsky BA, Peters EJG, Senneville E, Berendt AR,
Embil JM, Lavery LA et al. Expert opinion on the
management of infections in the diabetic foot.
Diabetes Metab Res Rev 2012;28(1):163–78.
4 Fujii M, Terashi H, Tahara H. Efficacy of Magnetic
Resonance Imaging in Diagnosing Osteomyelitis in
Dabetic Foot Ulcers. J Am Podiatr Med Assoc
2014;104(1):24-9.
12
7 Rayman G, Vas PR, Baker N, Taylor CG Jr, Gooday
C, Alder AI et al. The Ipswich Touch Test: A simple
and novel method to identify inpatients with diabetes
at risk of foot ulceration. Diabetes Care
2011;34:1517-8.
8 Morrison WB, Schweitzer ME, Batte WG, Radack DP,
Russel KM. Osteomyelitis of the foot: relative
importance of primary and secondary MR imaging
signs. Radiology 1998;207:625-32.
9 Aragón-Sánchez J. Treatment of diabetic foot
osteomyelitis: A surgical critique. Int J Low Extrem
Wounds 2010;9:37-59.
10 Ha Van G, Siney H, Danan JP, Sachon C, Grimaldi A.
Treatment of osteomyelitis in the diabetic foot.
Contribution of conservative surgery. Diabetes Care
1996;19:1257-60.
11 Armstrong DG, Lavery LA, Harkless LB. Validation of
a diabetic wound classification system: the contribution of depth, infection, and ischemia to risk of
amputation. Diabetes Care 1998;21:855–9.
12 Wagner FW. The dysvascular foot: a system for
diagnosis and treatment. Foot Ankle 1981;2:64–122.
13 Chan JC, Malik V, Jia W, Kadowaki T, Yajnik CS,
Yoon KH, Hu FB. Diabetes in Asia: epidemiology, risk
factors, and pathophysiology. JAMA 2009;301:2129–
40.
EWMA Journal 2015 vol 15 no 1
WOUND
DEBRIDEMENT
www.soering.com
Thorough and selective.
Ultrasonic-Assisted Wound Debridement (UAW).
The usage of UAW ensures a quick and safe cleansing of chronic and acute wounds. The innovative
debridement procedure removes non-viable tissue and biofilms while preserving healthy tissue. With its
precise and reliable technology Söring offers you the benefit of effective and easy to handle products.
Effective removal of biofilms: Using Ultrasonic-Assisted Wound Debridement
Before UAW
After UAW
48-hour-old
biofilm*
300 µm
Disrupted biofilm
after 10 sec. UAW
at 10% ultrasound
intensity, 25 kHz*
100 µm
Söring GmbH | Justus-von-Liebig-Ring 2 | 25451 Quickborn | Germany
oth 2-32
o
b
r
u
o
Visit
A 2015.
at EWM
* Source: Biofilm Test Facility, University of Copenhagen
Become a faster
wound healer
VISIT US AT:
WOUND CARE CONFERENCE arranged by
SWEDISH NURSE WOUND
CARE ASSOCIATION
STOCKHOLM
20.-21. APRIL 2015
– Wounds often take far too long to heal.
– In each stage of the healing process much more oxygen than usual
is required.*
– Sufficient oxygen frequently can‘t get to the wound base.**
– Granulox Haemoglobin Spray draws extra oxygen deep down to
the wound base.***
– The healing process is significantly accelerated.****
– Please visit our stand to learn more about how you can speed up
healing with your patients.
7TH NATIONAL CONGRESS
FOR CHRONIC WOUNDS
ATHENS
23.-24. APRIL 2015
EWMA, LONDON
13.-15. MAY 2015
7TH INTERNATIONAL SYMPOSIUM ON THE DIABETIC
FOOT, THE HAGUE
20.-23. MAY 2015
64TH CONGRESS NATIONAL SICPRE „LESSONS
FROM THE PAST –
CELEBRATING 80 YEARS OF
SERVICE“, MILANO
16.-19. SEPTEMBER 2015
SAFW D-CH JAHRESKONGRESS, ZÜRICH
17. SEPTEMBER 2015
HWMA, BUDAPEST
15.-16. OCTOBER 2015
Existed 6 years
before Granulox
After 39 treatments
with Granulox
Patient: 72, female, varicose and chronic venous insufficiency.
Venous leg ulcer, inner left leg
VIII. CHRONIC WOUNDS
SYMPOSIUM, TUHELJSKE
TOPLICE, CROATIA
OCTOBER 2015
WOUNDS UK ANNUAL
CONFERENCE,
HARROGATE
9.-11. NOVEMBER 2015
Granulox now has distributors in
more than 40 countries worldwide.
www.granulox.de
UK Distribution: www.infirst.co.uk
Haemoglobin Spray
* Dissemond J: The importance of oxygen in the ethiology and treatment of chronic wounds, Wundforum 2001; 2: 16-19 | ** Schreml S et al: Oxygen in acute and chronic wound healing, BJD 2010; 163: 257-268
*** Klode et al: poster presentation EWMA 2015 | **** Arenbergerova M, et al: Effect of topical haemoglobin on healing in patients with venous leg ulcers, Der Hautarzt 2013; 3: 180-185
Science, Practice and Education
Ex vivo platelet activation with
extended duration pulse electric
fields for autologous platelet gel
applications
V. Bogdan Neculaes1
A new, potential clinical standard for platelet activation
and perspectives for a more widespread adoption and
improved wound healing with platelet gels
ABSTRACT
Background: Abstract: Activated platelet-rich
plasma (PRP), also known as “platelet gel,” has
emerged in clinical use as the preferred delivery
vehicle for physiological combinations of autologous growth factors in wound-healing applications. Although a review of the literature shows
encouraging results for wound healing using
autologous platelet gels, a more widespread
adoption of this approach has been prevented
for the following reasons: a) lack of clinical standard for activation, b) challenges with current
activation methods, and c) incomplete reporting
of PRP preparation, PRP composition, and
growth factor levels post activation and how these
relate to clinical outcomes. We introduce here a
novel instrument-based method for ex vivo platelet activation that eliminates the various challenges posed by the current platelet activator
bovine thrombin (high cost, complex workflow,
possible side effects) and has the potential for
standardisation in clinical practice. We also
demonstrate growth factor release using our
instrument-based method and evaluate the
potency of these growth factor mixes in simple
models of angiogenesis and epithelialisation.
Andrew Torres1
Antonio Caiafa1
INTRODUCTION
Suboptimal wound healing represents a major threat
to public health and an enormous financial burden
to the healthcare system1. Tens of millions of patients
worldwide present every year with difficult-to-heal
wounds. The major causes of these chronic skin ulcers
are pressure (decubitus ulcers), venous stasis disease,
and diabetes mellitus. It is estimated that 1%–2 %
of the population in developed countries will suffer
from chronic wounds during their lifetime1. More
than 25% of the 29 million individuals with diabetes
in the United States will develop a diabetic foot ulcer
within their lifetime2 resulting in about 200 amputations daily3, 4.
There is a pressing need to significantly improve
outcomes for patients with chronic wounds, with
enhanced safety and much lower costs. The use of
autologous growth factors derived from platelets has
emerged in the last decade as a promising woundhealing approach and has been explored for a variety
of clinical applications, including diabetic foot ulcers,
dentistry, cardiac surgery, sports medicine, and cosmetic surgery5-8. Upon activation, platelets release
multiple growth factors9 with crucial roles in tissue
regeneration, angiogenesis, and epithelialisation10, 11.
Activated platelet-rich plasma (PRP), also known as
platelet gel, is a delivery vehicle for autologous growth
factors involved in the wound-healing cascade. Platelet
gel is the only known approach for delivering physiological combinations of growth factors than can act
synergistically to repair wounds.
The workflow for the preparation of autologous
platelet gel involves several steps: 1) blood draw from
the patient; 2) PRP separation from whole blood,
typically via centrifugation; 3) PRP activation using calcium chloride and thrombin (typically bovine
thrombin), which results in clotting and growth fac-
Christine Morton1
Adriana Larriera1
Steve Klopman1
Ken Conway1
Allen L. Garner2
1 GE
Global Research, Niskayuna, NY, USA, 12309
2 Purdue University, West
Lafayette, IN, USA, 47907
Correspondence:
[email protected].
com
Conflicts of interest: None

EWMA Journal 2015 vol 15 no 1
15
tor release; and 4) application of platelet gel to the wound
site.
Bovine thrombin is the most widely used platelet activator in the clinic. However, bovine thrombin is expensive, needs specific storage conditions and logistics,
and may trigger side effects. A previous study states that
“30% of the patients exposed to bovine thrombin develop
cross-reacting antibodies”12. Bovine thrombin-associated
immune-mediated coagulopathy costs from $16,584 to
$163,072 per patient13. Some countries - Europe, Japan
etc. - do not allow the use of bovine thrombin in the clinic14. Other types of thrombin (recombinant thrombin, human thrombin from donor plasma) have not overcome the
cost and side effect challenges15, and autologous thrombin
does not seem to be an effective platelet activator16. Additionally, the use of thrombin for platelet activation has
not been standardised in clinical practice. The lack of an
activation standard has been one of major challenges for
the clinical application of platelet gel.
A promising platelet activation method that offers several advantages over bovine thrombin (cost, ease of use,
no known side effects, potential for standardisation) has
emerged recently. This method uses electric field pulses
for ex vivo platelet activation17,18.
ergonomics needed for in vitro biology and research-level
wound-healing studies. The experimental workflow is
user-friendly, and instrument packaging and high-voltage
safety measures have been considered during the design
phase of this platelet-activation platform.
For this study, we used whole blood donated by healthy
human donors. PRP was separated from whole blood via
centrifugation (see Fig. 2) using an approved clinical centrifuge. The PRP was then placed in a commercially available low-cost electroporation cuvette that was sterile and
disposable (see Fig. 3) and exposed to extended-duration
electric field pulses. After activation via electrical stimulation, the activated PRP/platelet gel may be used for
wound-healing studies or in vitro analysis, as performed
here. Although the power electronics topology of the platelet activation instrument will be described elsewhere, it
should be mentioned that the instrument design properly
addresses the unique requirements posed by the specific
electrical properties of PRP (i.e., highly conductive, which
is very different from the low-conductivity buffers used
by other classes of instruments designed for electroporation). The instrument has electrical safety measures that
enable its easy operation by a healthcare professional with
minimal training.
2. AN INSTRUMENT-BASED PLATELET
ACTIVATION AS A POTENTIAL NEW CLINICAL
STANDARD
Research in the last few years has generated encouraging results for platelet activation with pulse electric fields
(PEF)17-20. Clotting and growth factors are released using nanosecond-duration electric field pulses (typically
hundreds of nanoseconds). Although preliminary studies reported lower levels of growth factor release from
pooled platelets exposed to nanosecond PEF compared
to those exposed to bovine thrombin17, further research
from GE Global Research showed growth factor release
at the same level or higher than that of bovine thrombin
activation18-20. It has been assumed that nanosecond PEF
is needed for platelet activation, since these short pulses
may produce specific intracellular effects involved in the
activation cascade (e.g., release of intracellular calcium)17.
However, pulse duration at the nanosecond level typically
requires expensive and at times unreliable power electronics.
We have discovered that electric pulses longer than 1
microsecond can also activate platelets. The power electronics architecture required to generate these extendedduration pulses is simpler, more reliable, and easier to
implement in clinical-grade instruments. We have built
the first instrument prototype for platelet activation using extended-duration pulses (see Figure 1). This instrument has the compactness, reliability, ease of use, and
3. MATERIALS AND METHODS
A. Platelet-rich plasma preparation
We handled whole blood and samples derived from whole
blood, such as platelet-poor plasma and PRP, using universal precautions. Single units of human whole blood
from individual donors were purchased and shipped overnight at room temperature from a commercial vendorb.
All studies used acid citrate dextrose as an anticoagulant.
We report here experimental results using the blood from
a single donor.
For a single preparation of PRP, 60 mL of whole blood
was drawn from the original unit of blood using the syringe and needle components of the preparation kitc. The
whole blood was injected into the separation consumable
(Fig. 2) and centrifuged using the clinically approved centrifuged. Complete separation by centrifugation typically
takes 15 minutes (see Fig. 2). We then collected PRP, with
16
Figure 1: Instrument prototypea for ex vivo platelet
activation with extendedduration pulse electric
fields. The cuvette/consumable -shown in Figure
3- with PRP is placed inside the transparent plastic box on top of the instrument (cuvette holder)
for electrical stimulation
to trigger platelet activation.
EWMA Journal 2015 vol 15 no 1
Science, Practice and Education
a yield of ~10 mL per 60 mL whole blood used. The PRP
was maintained at room temperature for all experiments.
The proportion of platelets in the prepared PRP was threefold higher than in the original whole blood sample.
Figure 2: Consumable used
for platelet-rich plasma separation from whole blood (picture showing the consumable
post centrifugation). Plateletrich plasma will be extracted
with a syringe from the compartment on the left, at the
interface between the yellow
layer consisting of plateletpoor plasma and the red layer consisting of red blood
cells (i.e., buffy coat).
B. Platelet activation
1) Reagents
All biochemical reagents were prepared and stored on
ice on the day of experiment. A stock solution of bovine
thrombine was prepared in saline solution (0.9% NaCl)
at a concentration of 10 U/μL to allow for 1:10 (vol/
vol) standard dilution in all experiments. Final concentration after addition to PRP was 1 U/μL. A stock
solution of CaCl2f was prepared at 1 M concentration
to allow for 1:100 (vol/vol) standard dilution in all
experiments. The final concentration after addition to
PRP was 10 mM CaCl2.
2) Thrombin-mediated activation of platelet-rich
plasma
Bovine thrombin (100 U/μL) was added to 0.5 mL PRP
with 5 μL PRPCaCl2 (1 M) in 1.5-mL sterile tubesg,
diluted 1:100 (final concentration 1U/μL), and then
incubated at room temperature. Tubes were then centrifuged at 10,000 rpm for 10 minutes. The resulting
supernatant was pipetted from the tube and either used
immediately or stored at or below -200C.
3) Pulse electric field-mediated activation of plateletrich plasma
For each experiment, 5 μL CaCl2 (1 M) was added to
0.5 mL freshly prepared PRP in a 2-mm cuvetteh (see
Figure 3). The sample was subsequently exposed to one
electric pulse of extended duration, transferred to a 1.5mL sterile tubei, and incubated at room temperature
for approximately 15 minutes. The samples were then
centrifuged at 10,000 rpm for 10 minutes. The supernatant was pipetted from the tube immediately after
the pulse and either used immediately or stored at or
below -200C.
C. Growth factor measurements
We measured the release of platelet-derived growth factor-AA (PDGF-AA), epidermal growth factor (EGF), and
vascular endothelial growth factor (VEGF) using the folEWMA Journal 2015 vol 15 no 1
Figure 3: A 0.5-mL
cuvette used to
couple electric
fields to plateletrich plasma for activation.
lowing three commercial kits: Human/Mouse PDGF-AA
Immunoassayj, Human EGF Immunoassayk, and Human
VEGF Immunoassayl. The measurement of PDGF-AA
and EGF required supernatant dilutions of 1:10 and 1:20,
respectively; for VEGF, no dilution was required. We followed the manufacturer’s protocol for each assay without
deviation.
D.Cell proliferation assays
MCF-10A cellsm were maintained in media supplemented with 10% foetal bovine serumn. These cells are a
non-tumourigenic epithelial line that should respond to
growth factors. Human dermal fibroblasts (HDF) and human dermal microvascular cells (HDMVECs)o were each
maintained in MCDB-131 mediump supplemented with
foetal bovine serum and a culture mediumq. The HDFs
model epithelialisation, with increased growth of these
cells indicating wound healing. The HDMVECs model
vascularisation, with increased growth of these cells indicating the formation of new blood vessels, also important
to wound healing.
Cells were seeded at a density of 200,000 cells/cm2
and incubated for 24 hours. The cells were then washed
twice with a balanced salt solutionr, and the medium was
replaced with serum-free medium and incubated for 24
hours. Supernatant from PRP was diluted to 10% vol/vol
with serum-free medium and added to the serum-starved
cells (total volume 100 µl), which were then incubated 24
hours. This dilution was determined experimentally with a
dose-response characterisation study. ATP was measured as
a function of cell proliferation using a luminescence ATP
a. GE Global Research
b. Bioreclamation, Westbury, NY, USA
c. SmartPReP2 APC+ PRP, Harvest
Technologies, Lakewood, CO, USA
d. Harvest Technologies
e. Catalog #91-010, BioPharm
Laboratories, Bluffdale, UT, USA
f. Sigma Aldrich, St. Louis, MO, USA
g. Eppendorf, Thermo Fisher,
Hamburg, DE
h. Molecular BioProducts, catalog
#21-237-2
i.Eppendorf
j. Catalog # DAA00B, R&D Systems,
Minneapolis, MN, USA
k. Catalog #DEG00, SEG00, PDEG00,
R&D Systems
l. Catalog # DVE00, R&D Systems
m.American Type Culture Collection,
Manassas, VA, USA
n. McCoy’s, Invitrogen, Grand Island, NY,
USA
o. VEC Technologies, Rensselaer, NY,
USA
p. Life Technologies, Grand Island, NY,
USA
q. EndoGro, VEC Technologies
r. Hanks Balanced Salt Solution (HBSS),
Invitrogen
s. ATPlite 1step Single Addition
Luminescence ATP Detection Assay,
Perkin Elmer, Waltham, MA, USA
17

!
!!
!!
detection assay systems according to the manufacturer’s
recommendations. The experimental conditions used for
all cell types were serum starvation, addition of unactivated PRP, addition of bovine thrombin-activated PRP,
and addition of PEF-activated PRP. Serum-starved cells
were given no additional growth factors; this is considered
a basal level of growth. All other conditions were compared
to serum starvation as the baseline.
activated PRP supernatant compared to serum-starved
cells (baseline control). Using HDMVECs (Fig. 5c) as a
surrogate for angiogenesis and HDFs (Fig. 5b) as a surrogate for epithelialisation, our results show that PEF creates
a platelet gel with significant effects on epithelialisation
and angiogenesis. It is interesting that trends in Figures 5a
(MCF10A non-tumourigenic epithelial cell line) and Figure 5b (HDFs) appear similar, which are satisfying results
since both of these cell lines are related to epithelialisation.
4. EXPERIMENTAL RESULTS
This section presents data on growth factor release from
clinical-grade human PRP and cell proliferation to demonstrate the potency of growth factors released upon activation by extended-duration PEF.
Figure 4 shows growth factor release results for unactivated PRP, bovine thrombin-activated PRP, and PRP
activated by PEF for three growth factors: PDGF-AA,
VEGF, and EGF. Compared with bovine thrombin activation, PEF activation triggered similar PDGF-AA release,
higher VEGF release, and much higher EGF release.
Figure 5 illustrates the effects of growth factors released
via bovine thrombin and PEF activation on cell proliferation. These experimental plots show cell proliferation after
24-hour stimulation with unactivated PRP supernatant,
bovine thrombin-activated PRP supernatant, and PEF-
5. DISCUSSION AND NEXT STEPS
Our paper introduces the concept of ex vivo platelet activation via extended duration PEF and presents the first
instrument prototype designed and validated experimentally for growth factor release from human PRP exposed
to electrical stimulation. Our experimental results confirm
!
!
the growth factor release
obtained recently with nano!
!
18
second PEF , showing that electric stimulation releases
growth factors at the same level or higher than that produced by bovine thrombin. Cell proliferation assays were
used as surrogate measures for wound healing. These assays
demonstrate the potency of growth factors released by
electrical stimulation of PRP with the instrument shown
in Figure 1. Recent in vivo experiments showed improved
wound healing with activated PRP via nanosecond PEF
compared to PRP activated by bovine thrombin21, the
!
!
!
!
!
Figure 4: Growth factor
release with unactivated platelet-rich plasma
(PRP NA, negative control), bovine thrombinactivated PRP (BT, positive control), and extended-duration pulse
electric field (PEF)-activated PRP. Each bar
represents the mean of
three measurements
and the error bars represent the +/- of standard deviation.
Figure 5: Cell proliferation after adding unactivated platelet-rich
plasma (PRP NA), or
growth factors released
via bovine thrombin
(BT) or extended-duration pulse electric fields
(PEF). The negative
control consisted of serum-starved cells. All
other conditions were
compared to serumstarved as the baseline.
Each bar represents the
mean of three measurements and the error
bars represent the +/of standard deviation.
!
!
!
!
!
!
!
!
!
!
!
!
!
!
!
"!
"!
18
!
EWMA Journal 2015 vol 15 no 1
Science, Practice and Education
platelet activator generally used in the clinic today. Additional encouraging findings also suggest that the PRP
activated by nanosecond PEF exhibits other improvements
over bovine thrombin activation (e.g., higher endogenous
antioxidant levels, reduced formation of reactive oxygen
species and matrix metalloproteinase-2), hinting towards
improved healing outcomes compared to today’s platelet
gels21. Since a recent study suggests that intracellular effects may be possible not only with ultra-short, nanosecond PEF but also via pulses of extended duration (>1
microsecond)22, one may expect similar beneficial effects
with extended-duration PEF activated PRP (e.g., improved healing, higher antioxidant levels, reduced reactive
oxygen species). In addition, the use of extended-duration
PEF makes possible a low-cost and reliable instrument for
clinical use. More details about the instrument platform
design will be presented elsewhere, but in terms of cost
per activation, the consumable used in this study (Figure
3) is about 20 times less expensive than bovine thrombin
23. This instrument-based method for PRP activation via
electrical stimulation could soon become a standard in
clinical workflows, since its activation performance is consistent, does not depend on the operator skill, is easy to
implement and control, and the activated PRP does not
appear to produce side effects.
Future work should focus on further exploring woundhealing benefits of platelet gels activated by extended-duration PEF in in pre-clinical and clinical applications. There
may be additional considerations for wound sizes that can
be addressed with autologous platelet gels when designing
these studies. One recent publication describes diabetic
wounds with an area of 185 cm2 treated with autologous
platelet gel24; another recent work stated that about 45–50
mL whole blood would be needed to generate enough
platelet gel to treat a 100 cm2 wound25. It is possible to
obtain 130–150 mL whole blood from a patient in a single
doctor visit to enable the treatment of a ~ 300 cm2 wound.
Nevertheless, trade-offs in terms of maximum wound size
for a patient would need to be made in the clinic.
The new technique of activating PRP at a push of a
button, in less than a second, may open the door to improved healing outcomes for patients worldwide suffering
from chronic wounds. Recent trends point towards the use
of platelet gels not only as a replacement for, but also in
addition to more traditional wound-healing approaches
(e.g., negative pressure therapy26). Thus, improvements in
wound healing may be enabled by the instrument-based
platelet activation method introduced here.
ACKNOWLEDGEMENTS
The authors would like to thank John Burczak (GE Global
Research) for supporting this research, and James Rothman (Yale University), Alan Michelson (Harvard Medical
School and Center for Platelet Research Studies at Boston Children’s Hospital) and Andrew Frelinger (Harvard
Medical School and Center for Platelet Research Studies
at Boston Children’s Hospital) for valuable suggestions
in this project.
REFERENCES:
1. Sen CK, Gordillo GM, Sashwati R, Kirsner R, Lambert
L, Hunt TK, Gottrup F, Gurtner GC, Longaker MT.
Human Skin Wounds: A Major and Snowballing
Threat to Public Health and the Economy. Wound
Repair Regen 2009;17(6):763–71
2. Diabetes Latest. Centers for Disease Control and
Prevention 2015. http://www.cdc.gov/features/
diabetesfactsheet/ [Accessed 27.03.15]
3. Dougherty EJ. An evidence-based model comparing
the cost-effectiveness of platelet-rich plasma gel to
alternative therapies for patients with nonhealing
diabetic foot ulcers. Adv Skin Wound Care
2008;21(12):568-75
4. Statistics About Diabetes. American Diabetes
Association 2014. http://www.diabetes.org/diabetesbasics/statistics/ [Accessed 27.03.15]
5. Mazzucco L, Medici M, Serra M, Panizza R, Rivara G,
Orecchia S et al. The use of autologous platelet gel to
treat difficult-to-heal wounds: a pilot study. Transfusion 2004;44(7):1013-8
6. KM Lacci, A Dardik. Platelet-rich plasma: Support for
its use in wound healing. Yale J Biol Med 2010;83:19.
7. Driver VR, Hanft J, Fylling CP, Beriou JM et al. A
prospective, randomized, controlled trial of autologous platelet-rich plasma gel for the treatment of
diabetic foot ulcers. Ostomy Wound Manage
2006;52(6):68-70, 72, 74 passim.
8. Tate KS, Crane DM. Platelet rich plasma grafts in
musculoskeletal medicine. J Prolotherapy
2010;2(2):371-6.
9. Frechette JP, Martineau I, Gagnon G. Platelet-rich
plasmas : growth factor content and roles in wound
healing. J Dent Res 2005;84(5):434-9.
10. Singer AJ, Clark RAF. Cutaneous wound healing. N
Engl J Med 1999;341(10):738-46.
EWMA Journal 2015 vol 15 no 1
11. Kiritsy CP, Lynch SE. Role of Growth Factors in
Cutaneous Wound Healing: A Review. Crit Rev Oral
Biol Med 1993;4(5):729-60.
12. Diesen DL, Lawson JH. Bovine thrombin: history, use,
and risk in the surgical patient. Vascular 2008;6
(Suppl 1):29-36.
13. W Alexander. Meeting highlights of the 30th
American College of Clinical Pharmacy annual
meeting. Pharmacy & Therapeutics 2009;34(12):68890.
14. ThermoGenesis Autologous Thrombin Processing
Device (TPD) Receives CE Mark to Allow Sales in
Europe. PR Newswire 2015. http://www.prnewswire.
com/news-releases/thermogenesis-autologousthrombin-processing-device-tpd-receives-ce-mark-toallow-sales-in-europe-54525062.html [Accessed
27.03.15]
15. DJ Cada, T Levien, DE Baker. Thrombin, Topical
(Recombinant). Hosp Pharm 2008;43(7):577–85.
16. Textor JA, Tablin F. Activation of equine platelet-rich
plasma: comparison of methods and characterization
of equine autologous thrombin. Vet Surg
2012;41(7):784-94
17. Zhang J, Blackmore PF, Hargrave BY, Xiao S, Beebe
SJ, Schoenbach KH. Nanosecond pulse electric field
(nanopulse): A novel non-ligand agonist for platelet
activation. Arch Biochem Biohpys 2008;471:240-8.
18. Torres AS, Caiafa A, Garner A, Klopman S, LaPlante
N, Morton C, Conway K, Michelson AD, Frelinger AL,
Neculaes VB. Platelet activation using electric pulse
stimulation: growth factor profile and clinical
implications. J Trauma Acute Care Surg 2014;77(3
suppl 2):94-100
19. Neculaes VB, Torres A, Caiafa A, Klopman S. Ex-vivo
platelet activation using electrical stimulation for
autologous platelet gel wound healing applications.
Presentation at the 24th Conference of the European
Wound Management Association, Madrid, Spain,
May 2014.
20. LaPlante N, Neculaes VB. DB Lee, SA Torres ,
Conway K, Klopman S, Caiafa A. Ex-vivo Platelet
Activation using Electric Pulse Stimulation. In
Proceedings of the 6th International Conference on
Biomedical Electronics and Devices (BIODEVICES
2013), Barcelona, February 11-14, 2013, Spain,
pages 202-8.
21. Hargrave BY. Autologous Platelet Rich Plasma
(Platelet Gel): An Appropriate Intervention for
Salvaging Cardiac Myocytes under Oxidative Stress
after Myocardial Infarction. Anat Physiol 2014;4:134
22. Weaver JC, Smith KC, Esser AT, Son RS, Gowrishankar TR. A brief overview of electroporation pulse
strength–duration space: A region where additional
intracellular effects are expected. Bioelectrochemistry
2017;87:236-43.
23. Cheng CM, Meyer-Massetti C, Kayser SR.A review of
three stand-alone topical thrombins for surgical
hemostasis. Clin Ther 2009;31(1):32-41
24. Tzeng YS, Deng SC, Wang CH, Tsai JC, Chen TM,
Burnouf T. Treatment of Nonhealing Diabetic Lower
Extremity Ulcers with Skin Graft and Autologous
Platelet Gel: A Case Series. Biomed Res Int 2013.
DOI: 10.1155/2013/837620
25. Obolenskiy VN, Ermolova DA, Laberko LA, Semenova
TV. Efficacy of platelet-rich plasma for the treatment
of chronic wounds. EWMA J 2014;14(1):37-41
26. Bello AMJ, Fernandez VM, Garcia FY, Oubina BR,
Anton FV, Perez AM et al. Complicated surgical
wound management with negative pressure therapy
and autologous platelet-rich plasma. Presentation at
the 24th Conference of the European Wound
Management Association, 14-16 May 2014, Madrid,
Spain
19
ACCELERATE
CLOSE
PREPARE
HEAL
Ulcers • Pressure ulcers • Diabetic foot ulcers
URGOSTART
URGOTUL
REPAIR
COMPRESSION
URGOREPAIR
KTWO
EffisciEncE 09/13 - crédits photos : fotolia, Thinkstock
the dressing with a superior efficacy(1),
now in a border version
INCLUDES A HEALING ACCCELErAtor
THE BEST WAY TO HEAL
NEW URGOSTART BORDER
It’s clinically proven by a double-blind comparative study, Challenge Study: thanks to its exclusive
healing accelerator TLC-NOSF, UrgOSTarT provides unequalled efficacy, superior to all neutral hydrocellular
dressings (1). UrgOSTarT is now available in a complete range to heal wounds even faster.
URGOSTART
CONTACT
(1)
URGOSTART
SOFT-ADHERENT
URGOSTART
HEEL
URGOSTART BORDER
8 x 8 cm - 13 x 13 cm - 15 x 20 cm
URGOSTART
SACRUM
CHALLENGE Study: comparative clinical study UrgoStart versus neutral hydrocellular. Healing speed = 10,83 mm2/day versus 5,15 mm2/day - p = 0,0056.
Meaume S. et al. Wound Repair and Regeneration 2012 ; 20 (4) ; 500-511.
Science, Practice and Education
adrid · Spain
EWMA n GNEAUPP 2014
Submitted to the EWMA
Journal, based on a presentation given at a free
paper session (Free paper
session: Pressure Ulcers)
at the EWMA - GNEAUPP
2014, Madrid
Pressure ulcer
reduction:
The role of unregistered healthcare support
workers in validation and prevention
BACKGROUND
Pressure ulcer (PU) incidence is a key quality
indicator of both patient safety and care quality,
and has a variety of uses, including benchmarking, organisational comparison, measurement
improvements, and commissioning.
Aim
To evaluate the impact of a specialist Health Care
Assistant (HCA) in Tissue Viability (TV) for PU
surveillance and prevention within an acute
hospital setting.
Methods
A comparison of an 18-month pre-change incidence audit with PU incidence monitored
monthly for 3 years.
Results
The total number of category 2-4 PUs acquired
in the hospital totalled 228 in the 2009/2010
reporting period (April to March). Validation was
not achieved in a significant proportion of cases
prior to the service evaluation. Due to changing
service needs during the first 2 years, the accuracy of category 1 PU data was inconsistent. By
the 2013/2014 reporting period (April to March),
the total number of category 2-4 PUs totalled 71,
representing a 69% reduction.
Conclusions
The TVHCA is able to respond quickly to reports
of new PUs at early stages of development. The
provision of primary validation ensures accurate
data monitoring and allows for early specialist
advice and guidance for PU prevention.
INTRODUCTION
The incidence and prevalence of pressure ulcers (PUs)
has been highlighted in the UK as a key indicator of
both patient safety and care quality1. Organisations
have undertaken the challenge of commissioners and
the general public to demonstrate improvements in
patient safety through data reporting.
The safety thermometer is a point prevalence audit
that is undertaken monthly in every National Health
Service (NHS) organisation in England. This audit was
introduced in 2012, and over 700 organisations were
using it routinely by 20132. Among other measures
of patient safety, PU prevalence is noted and reported
externally. The Tissue Viability Society3 produced a
consensus statement that raised concerns about the
use of prevalence as a measure of an individual organisation’s performance. Although prevalence identifies
the total number of PUs present in the population,
incidence measures new occurrences within the context of the setting4. An individual organisation can
be held accountable only for incidence levels, as they
often have little or no control over the delivery of services within another organisation. Although incidence
may be a more robust measure of performance and
progress for a distinct organisation, it is not without its
challenges. Ensuring that good inter-rater reliability,
prompt reporting of accurate data, and the provision
of meaningful statistical analysis is achieved can all
prove to be problematic in a large organisation.
In 2010, the Royal Devon and Exeter NHS Foundation Trust realised the importance of the accurate
collection of data on which to base its analysis of patient safety. Outcomes such as falls have incidence
levels that are easy to calculate, as there is little debate
about whether a fall is a fall. However, PUs can be
much more difficult for general nursing staff to accurately record and report. This fact is illustrated by
healthy debate amongst specialists about systems of
categorisation and where a particular lesion might fall
in that system5. This system does not even account for
Michael B. Ellis
BNurs(Hons) RN
Juliet Price
BSc(Hons) RN
Department of Tissue
Viability
Royal Devon and Exeter
NHS Foundation Trust
Barrack Road
Exeter
Devon
EX2 5DW
UK
Correspondence:
[email protected]
Conflicts of Interest: None

EWMA Journal 2015 vol 15 no 1
21
the debate about whether a lesion is indeed a result of pressure or some other aetiology. The literature suggests that
training can improve the agreement between nurses about
the grade of the lesion. One particular study, which used
photographs to assess agreement between nurses, demonstrated that reasonable levels of inter-rater reliability could
be achieved; however, the authors noted that differentiation could be more difficult in real practice6.
Although incidence monitoring had been undertaken
using a central electronic system for 3 years prior to this
evaluation, the accuracy of the data was questionable due
to problems with inter-rater reliability. It was determined
that the input of tissue viability (TV) specialists would be
required to obtain an accurate picture of PU incidence.
Due to pressure from rising costs, the recruitment of additional Registered Nurses (RNs) was infeasible, and so a
project was conceived to establish a Tissue Viability Health
Care Assistant (TVHCA) post. This post would focus
purely on PU validation and the provision of protocolbased advice to clinical staff to promote the delivery of
effective PU prevention.
METHODS
A retrospective audit of recorded pressure damage, including data about EPUAP and NPUAP (2009) category, the
site of the damage, whether the damage was sustained
in hospital or prior to admission, and the hospital ward
where the damage was first noted, was undertaken from
May 2009 until October 2010. A prospective audit of
the same data was collected for a 3-year period from the
start of this service evaluation. Data for a further 7 month
period was also available after the defined end-point of the
project at the time of submitting this article and was not
included in the study.
The TVHCA recruited to the post was an experienced
HCA with experience in general nursing care on acute
inpatient wards. As part of the training process, the TVHCA was required to undertake PU classification training,
including the use of an electronic learning programme
(PUCLAS) and PU risk assessment training. In addition to
theoretical learning, two weeks of supervised practice was
conducted to ensure consistent validation. Routine monitoring of a random sample of 5 patients was undertaken
on a weekly basis as a quality assurance measure, and all
category 2, 3, or 4 PUs were independently validated by
a TV Clinical Nurse Specialist (CNS).
Using a ward-based electronic reporting system (White
board), all pressure damage or suspected pressure damage
was recorded when noted by ward nursing staff. The damage was graded by ward staff according to the EPUAP and
NPUAP classification system7. The ward staff also noted
whether the patient developed the pressure damage during
this hospital episode or if it was present upon admission
22
to the facility (i.e., developed at home, a care home, or
another facility).
On a daily basis (weekdays only), the TVHCA would
run a report and obtain records of all damage recorded
for the previous 72 hours (to account for weekends and
bank holidays). Every patient with hospital-acquired pressure damage graded as a category 2 or above would then
be reviewed by the TVHCA. The category of damage
was validated and early interventions were implemented
with protocol-based advice. There were no pre-defined
quantitative measures by which to judge success beyond
a pragmatic view of incidence reduction for category 2-4
hospital-acquired PUs with a progressive downward trajectory across the 3-year period. Data are presented in a
descriptive way to show the incidence figures.
Due to the success of the service evaluation during the
study period, additional funding was made available to
extend this programme to include all hospital-acquired
pressure damage and all community-acquired pressure
damage.
RESULTS
The PUs are reported by the month of the patient’s discharge rather than the month in which the PUs were
validated, which is a pragmatic choice that was made to
fit with the reporting requirements of the service commissioners. The monthly external report displays the data
for all the PU categories. At the start of the project period, category 1 PUs were validated by the TVHCA but
as reporting improved and the number of pressure ulcer
requiring validation increased, it was not possible to continue validating category 1 PUs. Both hospital-acquired
category 1 PUs and all community-acquired PUs were not
validated between October 2012 and April 2013 when a
second TVHCA was recruited. Graph 1 displays data that
relate to hospital-acquired category 1-4 PU data. Graph 2
displays only category 2-4 PU data, the measure by which
the project success was evaluated.
Prior to the service evaluation, the retrospective audit
revealed a category 1-4 PU incidence rate of 2.77 per 1000
bed days and a category 2-4 PU incidence rate of 0.81
per 1000 bed days. The total incidence rate per 1000 bed
days for the whole service evaluation period was 1.91 for
category 1-4 and 0.53 for category 2-4 PUs. In the period
following the completion of the service evaluation, this
rate has continued to fall to an incidence rate per 1000
bed days of 0.70 and 0.23, respectively.
DISCUSSION
The downward trajectory of hospital-acquired PU in all
categories is in part attributed to a better understanding of
the data. Using the HCAs to validate the PU category and
the origin of the PU has proven to be an effective way to
EWMA Journal 2015 vol 15 no 1
Science, Practice and Education
Category 1-4 per 1000 Bed Days
4.50
4.00
Preliminary Audit
Number of Pressure Ulcers per 1000 Bed Days
3.50
3-Year Project Period
3.00
Validation
of category
1 PU restarted
Validation
of category
1 PU
stopped
2.50
2.00
PostProject
Audit
1.50
1.00
0.50
0.00
Month
Graph1: Category 1-4 incidence reduction data.
Category 2-4 per 1000 Bed Days
2.50
Number of Pressure Ulcers per 1000 Bed Days
2.00
Preliminary audit
1.50
1.00
3-Year Project Period
Postproject
audit
0.50
0.00
Month
Graph 2: Category 2-4 incidence reduction data.
gather this data in a consistent and reliable way. However,
there are some limitations to the data presented.
The data gathered is not able to differentiate between
the number of PUs initially reported and the number validated. However, there exists evidence that good validation
positively affects the number of PUs reported externally.
The project’s success in more accurately determining
EWMA Journal 2015 vol 15 no 1
pressure damage in the hospital demonstrates a need to
more accurately understand the impact that communityacquired pressure damage has on incidence figures. The
increase in workload and the number of patient visits
generated by validating all categories of pressure damage
regardless of its origin led to the pragmatic decision to
stop the validation of category 1 damage by the HCA in
23

Graph 3: Point prevalence audit data.
August 2012. A 25% increase in the number of category
1 PU was recorded in the following year’s data. Although
these PUs were validated by ward matrons, the quality and
reliability of the validation is questionable. Anecdotally,
the TVHCA noted that patients were receiving either too
much or too little intervention based on inaccurate assessments of the aetiology and severity of PUs. The reallocation of workload, additional funding, and an adjustment
in work practices allowed the team to expand. In July
2013, an additional 0.5 whole-time equivalent TVHCA
was employed to further extend the validation and advice
service. In the following 12 months, the incidence of category 1 PUs fell by almost 50%. Although this is not direct
proof that validation and advice is responsible for this
decrease, and other factors may have played a significant
role, it is difficult to believe that validation and advice does
not contribute significantly.
The reduction of incidences reported correlates with
a reduction in total prevalence reported (Graph 3). The
prevalence data is gathered from the safety thermometer
and although the data is more stable as would be expected
from prevalence figures compared to the national data
suggesting prevalence of between 4.4% and 4.7% in 201320148 There is a natural link due to incidence validation,
but because the TVHCA also validates all communityacquired pressure damage noted within the acute hospital,
many of these incidences are removed from the reported
data. This has been reported as being due primarily to
incorrect aetiology. Because of payments linked to incidence reduction targets9, there is a temptation to attribute
PUs to another healthcare provider. This would keep the
prevalence figures high but reduce our own incidence figures. The validation undertaken by the TVHCA has been
shown to be a robust mechanism for monitoring both sets
of data and ensuring agreement.
24
Although data validation is a key component of this
role, the front-line clinical advice regarding risk and riskprevention strategies has allowed the TV service to be
more visible and more responsive. The ward staff now
have greater access to advice and support from someone
who can be physically available rather than available by
phone only. There is no data to distinguish the impact that
this availability has had. Anecdotally, it has been reported
by ward-based staff that the visibility of the TVHCA has
had a significant impact. The awareness of PUs has been
raised and support to provide appropriate intervention
has been optimised.
In the first 12 months of the evaluation between November 2010 and October 2011, there were 368 category
1, 130 category 2, 57 category 3, and 3 category 4 PUs. In
the final 12 months of the evaluation between November
2012 and October 2013, there were 359 category 1, 59
category 2, 18 category 3, and 0 category 4 PUs, which
represents a reduction of 9 category 1, 71 category 2, 39
category 3, and 3 category 4 PUs. Based on estimates of
the average cost for the treatment of PUs in the UK10,
the organisation has shown comparative savings for the
health economy from year 1 to year 3 of the service evaluation of £10,926 in category 1, £372,211 in category 2,
£162,738 in category 3, and £42,324 in category 4 PUs.
This represents a total of £588,199 per year assuming
that approximately the same number of PUs would have
developed each year without this programme and that the
average costs of healing are representative of the local population healing rates. The average cost of a band 3 nurse
(TVHCA) was calculated at £17,794. When compared
with the potential economic advantages of this role and
the apparent cost savings generated by reduced incidence,
it is difficult to argue against the benefit of a TVHCA. As
a result, other specialist areas of practice, such as diabetes,
EWMA Journal 2015 vol 15 no 1
Science, Practice and Education
have devised similar roles to aid with the monitoring of
care and delivery of protocol-based advice to ward staff.
CONCLUSION
The accurate measurement of incidence allows for a more
robust report of the safety of care delivered within an organisation. This service evaluation has been responsive to
changing needs within the organisation about the validation of pressure damage and, as such, has evolved. During
periods of change, the role of the TVHCA has continued
to develop, and the extent to which their input is necessary has become apparent. Using an unregistered member
of the healthcare team allows for a cost-effective way of
providing protocol-based advice and guidance to frontline clinical staff, and has improved both the validity and
reliability of data collection. Although the reduction in
incidence cannot and should not be wholly attributed to
the input of the TVHCA, this reduction demonstrates
the important role that accurate data can play in assessing
service improvements in an open and honest way.
Implications for clinical practice:
n Healthcare organisations can improve the reliability of pres
sure ulcer validation data to enable more accurate reporting
of this quality indicator with targeted investment.
n Patient outcomes can be improved by providing a higher
level of clinical support and early intervention.
n Front-line clinical staff who observe improvements in safety
outcomes for patients may have improved levels of morale
and work in a more proactive way as a team.
n Healthcare organisations may be able to make significant
cost savings or attract bonuses by demonstrating improve
ment in incidence levels.
Further research:
n A qualitative study to explore the reported impact of the
TVHCA would be useful in understanding the way that this
role is able to support practice in comparison to specialist
nurses.
n A retrospective audit of the difference between recorded
pressure ulcers prior to validation and subsequently validat
ed pressure damage may help in understanding the educa
tional needs of front-line nursing staff.
REFERENCES
1.Department of Health. The NHS outcomes
framework 2012/13. London: Department of Health;
2011
5.White R, Clark M, Newton H. Is pressure ulcer
classification working for clinicians? Wounds UK
2012;8(4):12-4.
2.Power M, Fogarty M, Madsen J, Fenton K, Stewart K,
Brotherton A, Cheema K. Harrison A, Provost L.
Learning from the design and development of the
NHS Safety Thermometer. Int J Quality Health Care
2014:26(3):287-97.
6. Beeckman D, Schoonhoven L, Fletcher J, Furtado K,
Heyman H, Paquay L, et al. Pressure ulcers and
incontinence-associated dermatitis: effectiveness of
the Pressure Ulcer Classification education tool on
classification by nurses. Qual Saf Health Care
2010;19(5):e3.
3.Dealey C, Chambers T, Beldon P, Benbow M,
Fletcher J, Fumarola S, et al. Achieving consensus in
pressure ulcer reporting. J Tissue Viability
2012;21(3):72-83.
4.Shields L, Twycross A. The difference between
incidence and prevalence. Paediatric Nursing
2003;15(7):50.
EWMA Journal 2015 vol 15 no 1
7. European Pressure Ulcer Advisory Panel and National
Pressure Ulcer Advisory Panel. Treatment of pressure
ulcers: Quick Reference Guide. Washington DC:
National Pressure Ulcer Advisory Pane; 2009.
8.Clinical Audit Support Unit. NHS Safety Thermometer: Patient Harms and Harm Free Care, England,
November 2013 - November 2014, official statistics.
London: Health and Social Care Information Centre
2014.
9.NHS Institute for Innovation and Improvement.
Commissioning for Quality and Innovation (CQUIN)
payment framework. In: CQUIN Framework. 2013:
http://www.institute.nhs.uk/commissioning/pct_portal/
cquin.html [Accessed 1 May 2014].
10.Dealey C, Posnett J, Walker A. The cost of pressure
ulcers in the United Kingdom. J Wound Care
2012;21(6):261-6.
25
E-Learning
about Pressure Ulcers and Incontinence
- Associated Dermatitis (IAD)
What is new?
• Four modules:
• Introduction to pressure ulcers
• Introduction to Incontinence- Associated Dermatitis (IAD)
• Pressure ulcer classification
• Differentiation between pressure
ulcers and IAD
• Assessment modules and certificate
• Separate assessment module including
cases and photographs
• Simpler navigation and content
separation
EPUAP members have free access to PUCLAS3!
More information available at www.epuap.org and www.PuClas3.UGent.be
Science, Practice and Education
adrid · Spain
EWMA n GNEAUPP 2014
Submitted to EWMA Journal, based on a presentation given at a free paper
session (Free paper
session: Quality of life) at
the EWMA - GNEAUPP
2014, Madrid
Measuring change in
limb volume to evaluate
lymphoedema treatment
outcome
ABSTRACT
The accurate, non-invasive measurement of limb
volume in patients with lymphoedema is important in
the clinical and research setting.
Aim
This paper provides an overview of the practical
approaches to assessing limb volume and calculating
changes in limb volume after treatments in patients
with unilateral lymphoedema.
Methods
Techniques for assessing limb volume are described,
and a case study example is presented. A compression
bandaging system comprised of a foam roll and cohesive, inelastic bandages was applied to 9 patients with
unilateral lymphoedema on 6 occasions over a 12-day
treatment period. Two parameters for measuring the
changes in limb volume after the course of treatment
were used to evaluate treatment outcomes.
n Parameter 1: percentage change in excess
limb volume over time.
n Parameter 2: percentage change in absolute
limb volume over time.
Results
In 9 patients, the mean percentage change in excess
limb volume at Day 12 was 35%, and the mean percentage change in absolute limb volume was 8%.
Conclusions
The two parameters for calculating changes in limb
volume are not interchangeable. Parameter 1 is only
suitable for patients with unilateral lymphoedema, but
provides the information on the reduction of lymphoedema (excess) volume. Parameter 2 can be used
for patients with bilateral lymphoedema, where no
comparator or unaffected limb is available. Both
parameters should be reported in research, and both
limbs should be measured, if possible. However,
Parameter 2 should be used with caution, as the
percentage change is based on the whole limb volume,
rather than the more accurate excess limb volume as
a measure of lymphoedema.
INTRODUCTION
A key characteristic of lymphoedema is increased
limb volume. The accurate, non-invasive measurement of limb volume is essential in the clinical
and research setting. The change in limb volume
is an important treatment outcome in determining the effect of decongestive treatments, such as
compression bandaging. This manuscript provides
an overview of the practical approaches for assessing limb volume and describes two parameters
for calculating the changes in limb volume over
time. Nine patients with unilateral lymphoedema
participated in an audit of a lymphoedema bandaging system comprised of a foam roll and cohesive inelastic bandages (Fig. 1). This bandaging
system was applied on 6 occasions over a 12-day
treatment period.
WHY MEASURE LIMB VOLUME?
Measuring limb volume can be a useful tool in
establishing the extent and stage of lymphoedema
and identifying the treatment outcomes1,2. In patients with unilateral lymphoedema, the difference
between the affected and unaffected limb volume
is expressed as the excess limb volume, which is
often reported as a percentage of the volume of
the unaffected limb (Table 1). A grading system
for unilateral lymphoedema based on the excess
limb volume has been established2:
Anne F. Williams
PhD, MSc, RN, DN, Dip
Nurse Ed
Lecturer in Nursing
Queen Margaret University
Edinburgh
EH21 6UU
Scotland
Justine Whitaker
MSc, RN
Director and Lymphoedema Nurse Consultant,
Northern Lymphology Ltd,
Senior Lecturer, University
of Central Lancashire, UK
Correspondence:
anne@esklymphology.
co.uk
Financial support was
provided from Activa
Healthcare for the
bandaging audit and the
original presentation at
EWMA 2014. This
manuscript is based on
the original presentation.
n
<20% = mild lymphoedema
n 20–40% = moderate lymphoedema
n >40% = severe lymphoedema
In patients with bilateral lymphoedema, monitoring the volume of each limb can provide information on the treatment and self-management
outcomes over time, thus enabling both patients
and practitioners to recognise any change in individual limb size. However, as there is no unaf
EWMA Journal 2015 vol 15 no 1
27
Figure 1: Application of the bandaging
system, which was comprised of the spiral application of a foam roll* and the
figure-of-eight application of the cohesive, inelastic bandages**
* Rosidal Soft, Lohmann & Rauscher, Rengsdorf, Germany ** Actico, Activa Healthcare, Staffordshire, United Kingdom
fected control limb, the
actual (excess) volume
of lymphoedema cannot be accurately established in someone with
bilateral swelling. Similarly, no fully validated
and reliable method exists for establishing the
lymphoedema volume
in patients with swelling in the head, neck,
genitalia, and trunk2.
TECHNIQUES FOR
MEASURING LIMB
VOLUME
Various techniques for
measuring limb volume
have been reported in
the literature.
n Tape measure
n Water displacement
n Perometer
TAPE MEASURE
This is the most practical and portable technique in the therapeutic
setting. Most commonly, the limb is marked
and measured at 4-cm
intervals1. Circumferential measurements
are recorded (Table 1),
and measurements can
be compared over time
for each point, thereby
28
Table 1: Recording circumferential measurements in Patient A (a woman with lower limb
lymphoedema). The cylinder equation is used.
Before treatment
After treatment
Right limb
Left limb
Right limb
Left limb affected
unaffected (cm) affected (cm)
unaffected (cm)
(cm)
DISTAL
21.7
29.0
21.4
25.5
24.0
33.1
23.6
28.5
28.4
38.7
28.1
32.6
33.4
42.2
33.3
38.6
35.9
43.6
35.5
37.5
36.0
44.0
35.8
40.0
35.2
43.1
35.0
39.5
34.0
40.3
33.7
37.6
34.3
41.0
34.0
38.4
Distal limb volume0
2,904
4,524
2,856
3,651
(ml)0
Excess volume (ml)0
1,620
795
% excess0
56%
28%
PROXIMAL
38.5
44.0
38.8
41.5
41.2
46.3
41.5
44.1
44.0
49.8
43.2
45.5
48.0
52.0
48.0
47.0
51.9
51.9
51.5
51.6
53.0
57.0
53.2
56.6
55.5
57.9
56.5
57.7
57.5
59.8
57.9
60.2
Proximal limb0
6,145
7,045
6,182
6,609
volume (ml)0
Excess volume (ml)0
899
427
% excess0
15%
7%
Total limb volume0
(ml)0
Excess volume (ml)0
% excess0
9,050
11,569
9,038
10,260
2,519
28%
-
1,222
14%
-
EWMA Journal 2015 vol 15 no 1
2
Science, Practice and Education
Table 2: Two equations for calculating limb volume
Volume of a cylinder: the limb is viewed as a series of
cylinder-shaped segments.
Volume of each segment = C²/π
C is the circumference at the midpoint of a segment
with a length of 4 cm. Therefore, the starting point
for the first measurement is 2 cm above the wrist or
ankle.
Total limb volume is determined by the sum of the
segment volumes.
Volume of a truncated cone: the limb is viewed as a
series of truncated cone or frustrum-shaped
segments.
Volume of each segment = L/12π (C1² + C1 C2 + C2²)
C1 and C2 are the circumferences at either end of a
segment length (L). The starting point for the
measurement is at the wrist or ankle, which
represents the first point of the distal truncated cone.
Total limb volume is determined by the sum of the
segment volumes.
Table 3: Limb volume calculations before treatment in Patient A
Total limb volume
The calculation of total limb volume (ml):
Right leg: 9,050
Left leg: 11,569
Excess limb volume comparing affected and unaffected limbs
The difference between the limb volume of the affected and unaffected limbs in a patient
with unilateral lymphoedema (ml):
11,569 – 9,050 = 2,519
Percentage difference in excess volume
The excess limb volume is expressed as a percentage of the unaffected limb volume. This 3
indicates how much larger the affected limb is compared to the unaffected limb.
2,519 x 100 = 28%
9,050
Volume of different segments of the limb
The limb is divided into the distal and proximal segments, and the total volume, excess
volume, and percentage excess volume are reported for each segment. This is particularly
useful if the swelling is not evenly distributed (for example, below the knee only).
Distal segment volumes (ml)
Proximal segment volumes (ml)
Affected distal segment: 4,524
Unaffected distal segment: 2,904
Excess volume of distal segment: 1,620
% excess volume of distal segment:
1,620 x 100 = 56%
2,904
Affected proximal segment: 7,045
Unaffected proximal segment: 6,145
Excess volume of proximal segment: 899
% excess volume of proximal segment:
899 x 100 = 15%
6,145
EWMA Journal 2015 vol 15 no 1
giving precise information on
the distribution of swelling
and changes in limb circumference. Any change in limb
circumference may indicate an
increased or reduced fluid volume. These changes may also
be influenced by the alterations
in muscle mass, fat tissue, and
tissue fibrosis. As such, an unaffected limb should always be
measured as the control, as symmetrical change can be expected
in response to factors, including
exercise and weight loss.
Circumferential measurements can be entered into computer software programmes or
pre-programmed calculators to
calculate limb volume and, in
unilateral swelling, excess limb
volume. Most commonly, two
formulae are used to calculate
the volume (Table 2), although
the limb is rarely shaped like a
true cylinder or truncated cone
(frustrum). The calculation of
the limb volume, excess volume, and percentage excess volume can be established for the
whole limb, distal segments, and
proximal segments, thus providing specific information on the
distribution of oedema within
the limb (Table 1). In the example shown in Table 1, the excess volumes before treatment at
the distal and proximal sections
of the limbs are very different
(56% and 15%, respectively).
This indicates an uneven distribution of swelling, which is
not evident in the whole limb
volume excess figure of 28%.
When the measurement
method is precise and standardised, evidence indicates that circumferential methods are valid
and reliable3,4,5 (Table 4). The
actual limb volume achieved will
depend on the size and shape
of each limb segment and the
method of calculation6-8. The
formulae (cylinder or truncated
29

Table 4: Tips for achieving accuracy using the tape measure method
• Consistent limb position
• Consistent tape type, width, and tension: some practitioners use a pre-tensioned
tape to standardise
• Accurate and consistent marking of the starting and subsequent measurement
points throughout the limb: for example, marking the starting point as a consistent
distance from the base of the nail bed of the middle finger
• Standardisation of the measurement as below and above the marked point
• Consistent number of measurement points used
• Measurements by the same operator at the same time each day
Table 5: Using two outcome parameters to calculate changes in limb volume after
treatment in Patient A
Parameter 1:
Parameter 2
Pre-treatment excess volume: 2,519 ml
Pre-treatment absolute volume of the
affected leg: 11,569 ml
Post treatment excess volume: 1,222 ml
Post-treatment absolute volume of the
Change in excess volume:
affected leg: 10,260 ml
2,519 – 1,222 = 1,297 ml
% change in excess volume:
1,297 x 100 = 52%
2,519
Change in absolute volume of the affected
leg:
11,596 – 10,260 = 1,336 ml
% change in absolute volume:
1,336 x 100 = 15.5%
11,596
cone) must be used consistently and are not interchangeable5,7. The hand or foot is not included in the calculation
of limb volume, although approaches to measuring the
hand have been explored9.
WATER DISPLACEMENT METHOD
This method is often viewed as the gold standard2 and is
mainly used in research. It relies on measuring the amount
of water that is displaced from a container when the limb
or part of the limb is submerged. This provides information on the volume of the whole limb, including the hand
or foot, and can be used to accurately measure the hand or
foot alone7. The total volume of each limb can be used to
calculate the excess and percentage excess volume of the
whole limb, hand, or foot. This is generally not practical
for clinical use.
Circumferential measurements have been shown to
correlate well with water displacement3,5,10,11, although
the reported volumes from water displacement are often
slightly lower than those from the circumferential measurements4. Therefore, the methods are not interchangeable.
30
PEROMETER METHOD (OPTOELECTRONIC
PLETHYSMOGRAPHY)
This device uses infra-red sensors to measure the limb7,
12. The limb is placed within a frame that does not touch
the limb but is moved along the length of the limb. The
method has some disadvantages, as it is expensive, is only
suitable for the clinical setting, and relies on the patient
being able to hold the limb steady in a specific position:
for example, the arm is generally abducted. The machine
provides various readings, including limb volume, and
5
produces a visual representation of the limb, which may
be particularly useful for patient education.
Tan et al.13 examined the agreement between a vertically
orientated perometer and the tape measure method in volunteer legs. He concluded that the methods were reliable
but not interchangeable, as the tape measure overestimated
the limb volume in comparison to the Perometer.
CALCULATIONS OF LIMB VOLUME
Details of limb volume, excess limb volume, and percentage excess volume of the limb, as well as sections of the
EWMA Journal 6
2015 vol 15 no 1
Science, Practice and Education
Table 6: Use of Parameter 2 to calculate the percentage change in absolute limb volume
Example 1:
Example 2:
Limb volume before treatment: 10,000 ml
Limb volume before treatment: 16,000 ml
Limb volume after treatment: 8,000 ml
Limb volume after treatment: 14,000 ml
Reduction in limb volume: 2,000 ml
Reduction in limb volume: 2,000 ml
Expressed as a percentage of the starting Expressed as a percentage of the starting
treatment volume:
treatment volume:
2,000 x 100 = 20%
2,000 x 100 = 12.5%
10,000
16,000
Table 7: Measuring limb volume change in nine patients with unilateral lymphoedema
during a 12-day course of lymphoedema bandaging
Parameter 1: Change in excess limb volume
ID1
ID2
ID3
ID4
ID5
ID6
ID7
ID8
ID9
Mean
Excess
volume
(ml) at
Day 1 (pretreatment)
Excess
volume
(ml) at Day
12 (posttreatment)
Change
in
excess
volume
(ml)
%
change
in
excess
volume
1,788
1,789
3,501
1,446
1,708
3,485
4,182
4,760
5,650
3,145
1,045
968
2,581
1,107
471
2,536
3,736
2,295
4,944
2,187
-743
-821
-920
-339
-1,237
-949
-446
-2,465
-706
-958
-42
-46
-26
-23
-72
-27
-11
-52
-12
-35
Parameter 2: Change in absolute volume of the
affected limb
Before
After
Change %
treatments:
treatments in limb
change
affected
: affected
volume in limb
limb volume limb
(ml)
volume
(ml)
volume
(ml)
8,709
11,995
11,021
10,396
8,631
9,135
13,376
13,399
17,039
11,522
7,966
11,174
10,101
10,057
7,394
8,483
12,966
10,931
16,222
10,588
limb such as the distal and proximal segments, can be
calculated (Tables 1 and 3). Practitioners must understand
the implications of any data which are obtained through
software packages or calculators. This ensures that (1)
circumferential measurements are taken at the correct intervals with a precise starting point, (2) data are correctly
entered, and (3) any feedback that is given to patients or
recorded for the clinic or research purposes is accurate.
The formula for a cylinder requires the first circumferential measurement to be taken at 2 cm above the wrists or
ankle (midpoint of the cylinder). The frustrum formula
requires measurements at the end of each segment, so the
first circumference is taken directly at the wrist or ankle.
ESTABLISHING THE CHANGE IN LIMB VOLUME
AFTER TREATMENT
In a patient with unilateral lymphoedema, reporting
excess volumes before and after treatments also enables
a calculation of absolute and percentage change in excess
limb volume in relation to the pre-treatment excess volume (Table 5). This is the most accurate representation
EWMA Journal 2015 vol 15 no 1
-743
-821
-920
-339
-1,237
-652
-410
-2,468
-817
-934
-9
-7
-8
-3
-14
-7
-3
-18
-5
-8
of the actual change in the amount of lymphoedema in
the affected limb and is particularly useful for research
and audit purposes.
When a patient has bilateral lymphoedema, the excess
volume cannot be calculated. Instead, the reduction in
absolute limb volume may be expressed as a percentage
of the pre-treatment
7 total limb volume in each affected
limb. However, this does not provide precise details of the
lymphoedema volume or change in the lymphoedematous
component of the limb. As shown in Table 5, two outcome
parameters were used to calculate the changes in the affected limb of a patient with unilateral lymphoedema. The
two methods produced very different results. Although Parameter 1 relied on the unaffected leg as a control, the result from Parameter8 2 was influenced by the initial volume
of the limb.This is further illustrated in the examples given
in Table 6 where two limbs have each reduced by 2000mls,
although the calculation of percentage change, based on
the initial limb volumes of 10,000mls and 16,000mls, are
very different. Importantly, it is impossible to know how
much of an initial limb volume is due to lymphoedema
in a patient with bilateral swelling. 
31
APPLICATION IN AN AUDIT
Nine patients with unilateral lower limb lymphoedema
participated in an audit of a bandaging system incorporating the spiral application of a foam roll and the figureof-eight application of cohesive, short-stretch bandages14.
The patients were bandaged over 12 days with a total of
6 applications of the bandaging system (Fig. 1). The limb
volume was calculated using the formula for a cylinder
before and after the 12-day treatment course. Circumferential measurements were taken at 4-cm intervals along
the affected and unaffected limb, starting 2 cm above the
ankle. These data were entered into a spreadsheet to calculate the limb volume, excess volume, and % excess volume.
The changes in limb volume in the 9 patients (Table 7)
were expressed using two parameters.
n
Parameter 1: percentage change in excess limb
volume over time.
n Parameter 2: percentage change in absolute limb
volume over time.
RESULTS
The results from the 9 patients with unilateral lymphoedema show a mean reduction in the excess limb volume of
35% (range 11–72%) when Parameter 1 was used (Table
7). This was similar to the mean reduction of excess volume of 33.5%, which was reported by Badger et al.15 in
a study of 31 patients after 18 days of bandaging. Using
Parameter 2, the mean reduction in the absolute limb
volume in the 9 patients who took part in the audit was
8% (Table 7).
CONCLUSIONS
The two parameters for calculating the change in limb
volume yielded different results and were not interchangeable. Our results suggest that Parameter 1 is only suitable
for patients with unilateral lymphoedema, but provides
information on the reduction in lymphoedema volume.
Parameter 2 may be used for patients with bilateral lymphoedema, where no comparator (unaffected) limb is
available.
Both parameters should be reported in research, and
both limbs should be measured. However, Parameter 2
should be used with caution, as the percentage reduction
is based on the whole limb volume. The accurate representation of limb volume reduction cannot be achieved
using Parameter 2, where the extent of lymphoedema is
unknown, as a comparison with the unaffected limb is
not possible. However, both parameters are useful in the
clinical setting to monitor changes in the limb volume
over time.
To ensure accuracy, practitioners should use standardised, valid, and reliable approaches when assessing limb
volume change. Limb volume measurements should be
used in conjunction with other quality of life measures
and patient-reported outcomes to provide a more holistic
perspective on progress and change. Future work could
involve the use of a larger dataset to examine the correlations between different approaches to quantifying limb
volume reduction.
REFERENCES
1. Lymphoedema Framework. Best Practice for the
Management of Lymphoedema, International
consensus. London: MEP Ltd.; 2006. Available at:
http://ewma.org/fileadmin/user_upload/EWMA/
Wound_Guidelines/Lymphoedema_Framework_Best_
Practice_for_the_Management_of_Lymphoedema.pdf
[Accessed 03.11.14].
Bilateral and Unilateral Limb Edema. Phys Ther
2007;87(10):1362-8.
measurements for lymphoedema: implications for the
SNAC trial. ANZ J Surg 2008;78(10):889-93.
6. Sitzia J. Volume measurement in lymphoedema
treatment: examination of formulae. Eur J Cancer
Care (Engl) 1995;4:11–6.
12. Adriaenssens N, Buyl R, Lievens P, Fontaine C,
Lamote J. Comparative study between mobile infrared
optoelectronic volumetry with a Perometer and two
commonly used methods for the evaluation of arm
volume in patients with breast cancer related
lymphedema of the arm. Lymphology
2013;46(3):132-43.
2. International Society of Lymphology (ISL). The
diagnosis and treatment of peripheral lymphoedema.
Consensus document of the International Society of
Lymphology. Lymphology 2013;42:1-11.
3. Sander AP, Hajer NM, Hemenway K, Miller AC.
Upper-extremity volume measurements in women
with lymphedema: a comparison of measurements
obtained via water displacement with geometrically
determined volume. Phys Ther 2002;82:1201-12.
4. Taylor R, Jayasinghe UW, Koelmeyer L, et al.
Reliability and validity of arm volume measurements
for assessment of lymphedema. Phys Ther
2006;86:205–14.
5. Mayrovitz HN, Macdonald J, Davey S, Olson K. &
Washington E. Measurement Decisions for Clinical
Assessment of Limb Volume Changes in Patients With
32
7. Stanton AWB, Badger C, Sitzia J. Non-invasive
assessment of the lymphedematous limb. Lymphology
2000;33:122-35.
8. Katz-Leurer M, Bracha J. Test-retest reliability of arm
volume measurement in women with breast
cancer-related lymphoedema. J Lymphoedema
2012;7(2):8-13.
9. Borthwick Y, Paul L, Sneddon M, McAlpine L, Miller
C. Reliability and validity of the figure-of-eight method
of measuring hand size in patients with breast
cancer-related lymphoedema. Eur J Cancer Care
2013;22:196-201.
10. Karges JR, Mark BE, Stikeleather SJ, Worrell,TW.
Concurrent validity of upper extremity volume
estimates: comparison of calculated volume derived
from girth measurements and water displacement
volume. Phys Ther 2003;83:134–14.
11. Tewari N, Gill PG, Bochner MA, Kollias J. Comparison
of volume displacement versus circumferential arm
13. Tan C-W, Coutts F, Bulley C. Measurement of lower
limb volume: Agreement between the vertically
orientated perometer and a tape measure method.
Physiotherapy 2013;99(3): 247-51.
14. Whitaker J, Williams A, Pope D, Charles H, Muldoon
J. Sub-bandages pressures and comfort in a
lymphoedema bandaging system with a foam layer
and cohesive short stretch bandages. Poster at
Harrogate Wound Care Conference, 2013.
15. Badger C, Peacock J, Mortimer P. A randomisedcontrolled parallel-group clinical trial comparing
multi-layer bandaging followed by hosiery versus
hosiery alone in the treatment of patients with
lymphedema of the limb. Cancer 2000;7:2832-38.
EWMA Journal 2015 vol 15 no 1
SUPPORTING YOUR
CARE JOURNEY
One of the greatest challenges facing today’s medical professionals is complex healthcare systems.
A patient might circle back between many therapy phases, especially when the therapy process is
complicated by underlying health issues.
BSN medical aims to provide an integrated therapy-driven approach – grounded in a broad
portfolio of products, enhanced by insights into current therapeutic areas and complimented by a
progressive approach to partnerships.
DISCOVER THE POTENTIAL OF INTEGRATED THERAPY SOLUTIONS
Experience more and visit us at EWMA 2015, stand 3-50.
THERAPIES. HAND IN HAND.
www.bsnmedical.com
Camilla, 76, Brazil
Living with a leg ulcer
Make every day count
with superior absorption
Biatain® Silicone combines superior
absorption with gentle and secure fit
In the uncertain process of healing wounds, we all want to know we make
every day count. At Coloplast Wound Care, we listen and respond to what you
experience when caring for wounds. That is why we designed Biatain Silicone in
collaboration with Health Care Professionals.1
Biatain Silicone has the unique Biatain 3D polymer foam, which absorbs exudate
vertically, locks away fluid even under pressure, and conforms to the wound bed,
ensuring superior absorption.2,3,4
The perforated, soft silicone adhesive wound contact layer ensures a gentle
fixation to wound and body, for a comfortable and secure fit with minimal pain
upon removal of dressing.3,5,6
Biatain® Silicone
- Superior absorption with soft
adhesion for general purposes
References: 1. Data on file, 2012 2. Data on file, 2013 3. Chadwick P et al. Biatain Silicone Dressings: A case series evaluation, Wounds International 2014;5(1)
4. Marburger M, Andersen MB. In vitro test of eight wound dressings with silicone adhesive: Fluid handling capacity and absorption under compression, Presented at Wounds UK 2013
5. Klode J et al. Investigation of adhesion of modern wound dressings: a comparative analysis of 56 different wound dressings. J Eur Acad Dermatol Venereol. (2011) 25(8):933-9 6. Data on file, 2013.
The Coloplast logo is a registered trademark of Coloplast A/S. © 2015-04. All rights reserved Coloplast A/S, 3050 Humlebaek, Denmark.
Scientific Communication
adrid · Spain
EWMA n GNEAUPP 2014
Submitted to the EWMA
Journal, based on a
presentation given at
Plenary Session:
Innovation, Know-How,
and Technology at the
EWMA - GNEAUPP
2014, Madrid
Emerging targeted
technology to address
unmet clinical needs
- Implementing a development
and adoption strategy
When faced with a new or challenging clinical
situation, healthcare professionals often, of necessity, innovate by adapting or inventing new care
strategies. Despite having a clear drive to innovate
and create new medical devices and systems of
care, healthcare professionals have frequently not
been in the forefront of product development. As
a result, healthcare systems have received products
and services that were “pushed” to them by industry. These products may not be aligned with the
development strategy of healthcare organisations.
Moreover, they may not address perceived or actual patient needs. As such, they are not “owned”
by clinicians or end users.
Changes that are more radical or disruptive have
a greater likelihood of eliciting resistance to implementation. There will always be early adopters.
However, products or system changes are unlikely
to be widely disseminated if (1) the “technology”
fails to deliver or (2) there are inflated expectations.
WHAT IS INNOVATION?
Innovation is the successful implementation of
new ideas and is divided into three stages:
The CEO of the National Health Technology
Adoption Centre, Sally Chisholm, stated: “The
need for the rapid, widespread, and systematic
adoption of innovation within the NHS has never
been more acute.” The same clearly applies to all
healthcare systems. If this is the case, then why are
innovations not rapidly adopted and universally
applied? Currently, the Innovation/Adoption/Diffusion cycle for new medical devices is too long,
and it takes an estimated average of 17 years for
only 14% of new scientific discoveries to enter dayto-day clinical practice1. This introduces barriers
to full adoption and is often controlled by regulatory requirements, reimbursement, and healthcare
provider acceptance. If the process is too slow,
newer technology becomes available. Innovation
is then discouraged, as manufacturers are unable
to recoup development costs before the next wave
of products launches. The Dutch Royal Academy
of Science has recently produced a report2 entitled
“Evaluation of New Technology in Healthcare,”
in which they offer guidance on the evaluation,
use, and regulation of medical devices. The report
n
Invention or identification – finding new or improved ways of doing things through new devices, therapies, or systems
n Adoption – testing new or improved ways of doing things and putting them into practice
n Diffusion – replicating new or improved
devices, therapies, or processes across the
system
Although innovation is linked to a process of
improvement, it is frequently seen as part of the
change process. Innovation may be:
n
Incremental - building on and improving
existing practices
n Radical – solving existing problems using
a completely new approach
n Disruptive - creating an entirely new and
unexpected therapy, market, or mode of
working
WHAT IS INNOVATION WITHIN
HEALTH CARE?
“An idea, service, or product that is either new
to a healthcare system or applied in a way that is
new to that system and significantly improves the
quality of health and care wherever it is applied”.
Professor Peter Vowden
Consultant Vascular
Surgeon and Visiting
Professor of Wound Healing
Research, Bradford, UK
Clinical Director of the
NIHR Healthcare Technology Co-operative
for Wound Prevention and
Treatment in Bradford, UK.
Correspondence:
[email protected]
Conflicts of interest: None

EWMA Journal 2015 vol 15 no 1
35
The eight National Institute for Health Research (NIHR) Healthcare Technology Co-­‐operatives (HTCs) NHS Organisation Barts Health NHS Trust Cambridge University Hospitals NHS Foundation Trust Guy’s and St Thomas’ NHS Foundation Trust Sheffield Teaching hospitals NHS Foundation Trust Bradford Teaching Hospitals NHS Foundation Trust Clinical Area or Theme Chronic gastrointestinal disease Brain injury Cardiovascular disease Devices for Dignity Wound prevention and treatment (WoundTec HTC) Leeds Teaching Hospitals NHS Trust Colorectal therapies Nottinghamshire Healthcare NHS Trust, Institute of Mental health and neurodevelopmental Mental Health disorders University Hospitals of Birmingham NHS Foundation Trust Trauma management Table 1
The eight National Institute for Health Research (NIHR) Healthcare Technology Co-operatives (HTCs)
covers a number of issues that are relevant to all healthcare
systems, irrespective of the country or area in which they
provide services. However, the pressure to rapidly deliver
and adopt innovation must not be at the expense of patient
safety. Good evidence demonstrating clinical and cost effectiveness must be derived from well-constructed clinical
trials. Follow-up post-marketing surveillance data play a
vital role in ensuring that data derived from randomised
studies are repeated in real-world situations3. A criticism
that is frequently raised in medical device-related clinical
trials, particularly in the field of wound care products, is
a lack of consistency and comparability between studies.
This issue is frequently highlighted in systematic reviews4,
and the need to work in accordance with the CONSORT
statement is further emphasised5. To overcome this, a common platform for evaluation that is similar to the suggested
platform for telemedicine (MAST)6 should be introduced.
This framework would require both a generic “wound
care”-related core and a disease-specific focus that deals
with the characteristics of individual wound types, such
as diabetic foot ulceration, venous leg ulcers, malignant
wounds, or acute traumatic wounds.
“Innovation is an ongoing cycle ……. one without a
beginning or an end, where one idea always leads to
the next.”
Diffusion occurs for a number of reasons;
(1)Bottom-up pressure from patients, public demand, and individual choice;
(2)horizontal pressure from peers, outcome reporting, collaboration, competition, and marketing;
(3)top-down pressure from central requirements,
regulations, incentives, and guidance.
Diffusion is also dependent on the cost-effectiveness
model that supports the launch of the initial product, as
derived from the original clinical trials, which are replicated for general use. This model can be challenged by the
36
slow uptake of educational support within the healthcare
system, changes within the system itself, and the skill of the
general healthcare professional when compared to that of
an experienced research team. The Whole System Demonstrator trial7 of telemedicine has highlighted the need for
careful economic and clinical evaluations of new devices
and systems of care in the management of chronic disease8.
Technology acceptance can be related to two key functions: the perceived usefulness of the innovation and
perceived ease of use. When considering, developing, or
introducing innovation, address the following questions:
n
Is the new behaviour/system/device genuinely useful?
How will the “learner” know if it is useful?
n Is the new behaviour/system/device easy to use?
n If it is not easy to use, can anything be done to improve
it?
n
HEALTHCARE TECHNOLOGY
CO-OPERATIVES (HTCS)
In an attempt to address areas of unmet clinical need in the
NHS, the National Institute for Health Research (NIHR)
has established eight HTCs (Table 1), which have been
established to:
n
Act as a catalyst for the NHS “pull” for the develop ment of new medical devices, healthcare technologies,
and technology-dependent interventions.
n Focus on clinical areas and/or themes of high morbid ity, which have high potentials for improving the qual ity of life for NHS patients and improving the effective ness of healthcare services that support them.
n Work collaboratively with patients, patient groups,
charities, industry, and academics.
The NIHR WoundTec HTC specifically addresses innovation that is related to unmet needs in wound prevention
and treatment9. This HTC has specific aims:
EWMA Journal 2015 vol 15 no 1
Scientific Communication
n
Act as a platform for innovation
To carry out these aims, the NIHR WoundTec HTC is
Identify and develop promising concepts for medical working through a formal collaboration between strate devices
gic partners and a network of key stakeholders (patients,
n Provide theoretical, methodological, and design
patient groups, charities, academics, and industry). The
expertise and a clinical base to develop these concepts
HTC has taken on a leadership role in identifying unmet
into testable interventions and devices
needs and developing and translating integrated clinical
n Test the feasibility, effectiveness, cost effectiveness, and
and research knowledge to patient care, thereby improv acceptability of proposed innovations in NHS settings
ing the life of patients, enhancing standards of wound
and various care pathways and promote the spread of
management, and promoting wealth creation. 
Figure 1
best practice
Identifying areas of need: Patient and Public Involvement
n
Figure 1
Identifying areas
of need:
Figure
2 Patient and Public Involvement
Potential for increased features to impact production schedule, product cost, profit,
complexity, and adoption
Figure 2
Potential for increased features to impact production schedule, product cost, profit, complexity, and adoption.
EWMA Journal 2015 vol 15 no 1
37
“How do you make innovation possible? With a need
that launches an idea.”
One of the core strategies in this process is Patient Led
Innovation (PLI), which involves:
n
Transforming patient-identified needs into innovative
medical devices and/or services.
n Innovating existing products and services to meet the
needs of patients and carers.
n Speeding up the development process.
n Providing patient feedback and regular interactions
with designers, engineers, industry healthcare profes sionals, and researchers.
This is achieved by engaging with patients throughout an
innovation-led design process (Fig. 1). However, several
challenges remain. A proper way to engage with patients
to identify need must be implemented. Furthermore, the
conversion from product “push” to need-initiated “pull”
needs to be developed. End-user feedback during the design phase has the potential to improve effectiveness but
may also impact product cost and cost effectiveness when
additional features and functionality are introduced (Fig.
2).
When looking at innovation in wound care products,
Moues et al.10 asked if we, the healthcare professionals,
are one of the barriers to innovation. They commented
that although a greater understanding of wound biology
and technological advances have led to numerous improvements in wound care in the last two decades, the choice
of therapy still largely depends on high-quality marketing, expert opinion, and intuition, rather than scientific
evidence. They state that many healthcare professionals
continue to treat and dress wounds according to age-old
practices, despite the fact that new research shows that this
may not be the best treatment modality for the patient.
In the UK Chief Executive’s report by Sir David Nicholson
for the NHS in England, Sir David Nicholson recognised,
in his forward to Innovation Health and Wealth (2011),
the need for innovation. Paraphrasing some of his comments:
“Our ambition must be for an NHS defined by its commitment to
innovation, demonstrated both in its support for research and its success in
the rapid adoption and diffusion of the best, transformative, most innovative
ideas, products, services, and clinical practice.”
“Now and for the foreseeable future, we must meet health demands from
within our current real terms funding while at the same time improving
quality ……. This means that simply doing more of what we
have always done is no longer an option. We need to do things differently.
We need to radically transform the way we deliver services ……..
Innovation is the way – the only way – we can meet these challenges.
Innovation must become core business for us all.”
References
1. Westfall JM, Mold J, Fagnan L. Practice-based
research-”Blue Highways” on the NIH roadmap.
JAMA 2007;297(4):403-6.
2. KNAW Evaluation of new technology in health care.
In need of guidance for relevant evidence. 2014,
Amsterdam, KNAW.
3. Yera-Alos IB, Alonso-Carbonell L, Valenzuela-Silva
CM, Tuero-Iglesias AD, Moreira-Martinez M,
Marrero-Rodriguez I, et al. Active post-marketing
surveillance of the intralesional administration of
human recombinant epidermal growth factor in
diabetic foot ulcers. BMC Pharmacol Toxicol
2013;14:44.
38
4. Clark M, Black J, Alves P, Brindle C, Call E, Dealey C,
et al. Systematic review of the use of prophylactic
dressings in the prevention of pressure ulcers. Int
Wound J 2014;11(5):460-71.
5. Weller C, McNeil J. CONSORT 2010 statement:
updated guidelines can improve wound care. J
Wound Care 2010;19(8):347-53.
6. Kidholm K, Ekeland AG, Jensen LK, Rasmussen J,
Pedersen CD, Bowes A, et al. A model for assessment
of telemedicine applications: mast. Int J Technol
Assess Health Care 2012;28(1):44-51.
7. Greenhalgh T. Whole System Demonstrator trial:
policy, politics, and publication ethics. BMJ
2012;345:e5280; author reply e305.
8. Henderson C, Knapp M, Fernandez JL, Beecham J,
Hirani SP, Cartwright M, et al. Cost effectiveness of
telehealth for patients with long term conditions
(Whole Systems Demonstrator telehealth questionnaire study): nested economic evaluation in a
pragmatic, cluster randomised controlled trial. BMJ
2013;346:f1035.
9. Vowden P. New wound care HTC launches. J Tissue
Viability 2013;22(1):19-20.
10. Moues CM, Heule F, Legerstee R, Hovius SE. Five
millennia of wound care products--what is new? A
literature review. Ostomy Wound Manag
2009;55(3):16-22.
EWMA Journal 2015 vol 15 no 1
Make better
RESTORING
PEOPLE’S LIVES
At Acelity, we put patients at the
centre of everything we do.
Our vision is to restore people’s lives.
We do this in partnership with the healthcare
community who inspire us to innovate, facilitate
faster recoveries and improve standards of care.
We offer a portfolio of advanced wound healing
and tissue repair products with specialised
knowledge and support to better meet your needs.
Together we help people heal and be whole again.
4743 ACE/GLO/PRB4500
Meet us at the EWMA Conference in London
13-15 May 2015 – stand 3-20
©2014 KCI Licensing, Inc., LifeCell Corporation, and/or Systagenix Wound Management, Limited. All rights reserved. All trademarks designated herein,
unless otherwise noted, are proprietary to KCI Licensing, Inc., LifeCell Corporation, and/or Systagenix Wound Management, Limited, and/or their respective
affiliates and/or licensors. DSL#14-0739.SYX4743.EWMA (Rev. 3/15)
HydroTherapy
HydroClean® plus and HydroTac® are two perfectly
matched products both with unique mechanisms of action,
for the treatment of chronic and hard to heal wounds.
NEW website: www.hydrotherapy.info
Perfectly
matched!
1 HydroClean
®
plus
The unique Rinsing-Absorbing-Mechanism
cleans and activates the wound, stimulating
granulation tissue growth.
2 HydroTac
®
The innovative HydroGel Technology creates
an optimum wound environment and
stimulates epithelialisation, through active
moisture donation.
adrid · Spain
Juan Reig
Medical Doctor, Specialist
in General Surgery,
Former President of the
EUROREC
Institute, Osuna Health
Area, Andalucia, Spain.
Jose A. Valverde
Medical Doctor, Specialist
in Emergency Medicine,
Empresa Pública de
Emergencias Sanitarias
(EPES 061), Sevilla,
Andalucia, Spain.
Monica Reig
Medical Doctor, Specialist
in General and Digestive
Surgery, Surgery Department, San Juan de Dios
Hospital, Bormujos
(Sevilla), Andalucia,
Spain.
Keywords: health
technology, innovation,
ICT, early adopter,
technological trends,
transformational
technologies
Correspondence:
[email protected]
Reprints:
jose.valverde.albacete@
gmail.com
Conflicts of interest: None
42
Great opportunities ahead!
Don’t miss the boat!
Where tech meets health
care…
ABSTRACT
Technology is transforming almost everything
in our daily lives, and there are few spaces
or sectors not affected by this unavoidable
change. However, sometimes our pace of
coping with change is not always as good as
it should be. In this article, we review recent
technological breakthroughs and discuss
ways by which they can improve the work
of healthcare professionals and allow us to
deliver better care to our patients. Which
technologies will have the greatest impact
on wound management and the closely related field of chronic care? We suggest that
big data, 3D printing, communication and
collaborative technologies, and innovative
devices can lead to higher quality and more
efficient care.
Not only new technologies, but also new professional roles, societal challenges, and the
sense of personal empowerment are deeply
changing the way we deliver care. These
factors in combination with advancements
in medicine, genetics, neuroscience, new materials, nanosensors, increased consciousness
about environment and energy as well as the
influence of other non-medical disciplines
opens the way for progress in the healthcare
arena. Such advancements are closely tied
to ethical, privacy, and security concerns that
should be thoroughly considered.
EWMA n GNEAUPP 2014
Submitted to the EWMA
Journal, based on a
presentation given at
Plenary Session:
Innovation, Know-How,
and Technology
at the EWMA - GNEAUPP
2014, Madrid
INTRODUCTION
“Prediction is very difficult, especially about the future,” said Niels Bohr, winner of the Nobel Prize in
Physics. However, it is also true that we must take
risks. In our work and daily lives, we cannot rely
on making mistakes as a way of learning and avoid
guessing what may happen in the future. Based on
the evidence we have today, we use this article to
imagine how tomorrow will look. Contrary to many
opinions, we are convinced that the best is yet to
come.
That is, advances in medicine, neuroscience, genetics, information and communications technology
(ICT), and technology in general; new roles for individuals and society; and increasing concern for our
environment together set a foundation for progress in
the health sector, which appears full of opportunities.
These future developments will occur in a synergistic manner. Isolated advances are not only difficult but are often doomed to failure. The future is
relentless. We cannot hide and believe that we are
not going to be affected.
As individuals in a changing social environment
we want to play a leading role in the healthcare ecosystem and have key decision power over ourselves
and other public and private actors, whether organisations, providers, payers, or insurers.
Determinants of progress in the health sector include mobility; breaking the physical links to fixed
areas, organisations, or traditional processes; vanishing distance and barriers; democratisation of technology access; emergence of new professional roles;
generation of large amounts of information from
heterogeneous and accessible sources; and growing
interest in the environment and the proper use of
energy resources1.
Today’s technology enables us to more easily manage the healthcare policies we design and to implement our vision. It is no longer merely a tool for
EWMA Journal 2015 vol 15 no 1
Scientific Communication
executing an idea; rather, it has intrinsic value and acts
as a catalyst or enabler of strategy. As decision makers,
we cannot wait until a technology is mature or else we
will lose competitive advantage. Instead, we must become
“early adopters” if we want to differentiate ourselves, and
we must actively use and benefit from technology in our
daily lives, because its potential to improve quality of life
for the patients or support the role of health professionals
has never been more obvious.
TECHNOLOGICAL INNOVATIONS
In this current global economic crisis, the healthcare
system is highly valued by its users, who not only apply
constant and incremental pressure to gain access to the
last technological innovations but who also benefit from
affordability of common technologies. At the same time,
healthcare professionals do not perceive ICT as important
to their work.
There is a rationale for this changing environment.
As a driving force common to all industries and not just
the health sector, technology is now an integral part of
everyday life. Technology has become invisible and is incorporated as a natural part of life, not just for younger
generations considered “digital natives” but also for society
as a whole.
The intensity of innovation and the incorporation of
new technologies unprecedented, and the resulting changes increasingly affect us individually and collectively.
Moreover, the growth of computer networks, their increasing accessibility, and the rise of content sharing in
the cloud leads to a distribution of information across
devices and systems without barriers. Because the content
of the information is the same, only slight variations in
sizes and formats need to be considered when presenting
the information.
Another driver of change is that solutions from other
sectors are now permeating the health sector. We cannot
continue saying that healthcare is different and that strategies from other sectors do not work or do not apply to
our environment.
The concept of health itself is constantly evolving, not
only in relation to the paradigm shift from cure to prevention, but also in terms of including broader concepts
such as welfare or “wellness”, as well as integrating traditional remedies and other unconventional therapies. For
example, a currently available app for weight control not
only includes tools for measuring calorie intake, keeping
track of exercise, and monitoring metabolism, but also
incorporates information on personal mood, shared goals
among social networking groups, and personalised virtual
“coaching” messages.
The active presence of communities of action or groups
of people with common interests in diseases and related
EWMA Journal 2015 vol 15 no 1
conditions or their experiences in healthcare systems reflects a different reality of today’s society. We care more
and more about opinions, suggestions, tips, and ideas from
our neighbours in social networks, and this virtual meeting
space will be increasingly present as an everyday part of the
healthcare process, building the concept of “conversation”. 1
!
!
Figure 1. Word cloud of terms used in this report (www.worldle.net).
Aspects of the health system such as the experience of
patients—a concept that exceeds the classical term “satisfaction”—and good communication can influence the
quality of care and improve health outcomes. Such aspects are eventually recognised either because they improve
treatment adherence, for example, or because they generate
confidence and positively impact the course of a disease
or condition2. The incorporation of technology into our
daily lives can greatly improve patient experiences, allowing personalised communication and increasing a sense
of belonging in and closeness to the healthcare system.
In summary, we believe that technological and societal
innovations are directly influencing the challenges that
face our healthcare system at patient, professional, and
organisational levels.
IDENTIFYING TRENDS
The concept of “transformational technology” relates
to how some technological elements have the ability to
induce deeper disruptive changes than the functions for
which the technology was originally designed3,4. It is
opposed to adaptive technology or transition technologies considered as simple evolutions or improvements on
performance. Classic examples are the World Wide Web,
Internet search engines, and the mobile phone.
Experts consider six groups of technologies with the
potential to transform the healthcare sector5,6: big data,
connectivity (including interoperability), improvements in
computer manufacturing (e.g., micro and nanotechnology,
graphene), 3D printers, cloud computing, and the Internet
of Things. These are not considered isolated elements but
rather different pieces of a jigsaw puzzle. For example,
43

common healthcare technologies within the Internet of
Things, improved positioning systems, and miniaturisation can offer opportunities to reduce risks of medical or
diagnostic errors and enable less invasive treatments.
Let’s review the possible contributions of each of these
six technologies.
The amount of data produced is estimated to grow
by 60% annually. When we talk about big data7, we are
referring to the 2.5 quintillion (2.5 × 1018) bytes of data
generated daily8. Big data is characterised by the “4 V’s”:
volume, referring to the continued increase in the amount
of data produced; velocity, referring to the speed at which
data is generated and used; variety, referring to the heterogeneous nature of data obtained from multiple sources;
and veracity, referring to uncertainty in the value of data
and its contribution to decision making.
Connectivity is necessary to ensure that our technological world works smoothly. It is the “sine qua non” for
data exchange between devices or intercommunication
between machines. Connectivity must occur at high speed
and capacity, without barriers, to allow data to easily flow
in an unobstructed manner and to be filed automatically
but with some degree of control. Connectivity is one of
the biggest challenges of the near future due to the exponential increase in the number of connected devices
and terminals, the volume of data exchanged, the need
for connections to be permanently available and safe, the
numerous mechanisms and means of connections, and
the need for a single device to simultaneously connect to
different nodes of the network and in different ways. The
healthcare environment will become a hyper-connected
space where interoperability plays an unquestionable role.
Although computing power in the past has traditionally been linked to computers, today computer power is
present in most different devices in our everyday lives.
Improvement in the manufacture of computing elements
is another element of the technological transformation of
our health system. Nanotechnology and the miniaturisation of components, the integration of graphene circuits
and plates, and the embedding of computing modules in
almost any element of the healthcare environment will
profoundly change our near-future reality. As an example, chip-based systems for examination, diagnosis, and
treatment can be capable of transmitting data and images.
3D printers can also play a role in solving health problems. For instance, a recent New England Journal of Medicine paper describes the creation of an implant using a 3D
printer and biomaterials to treat a child with tracheobronchomalacia9. The possibilities of producing prostheses or
tissue on demand, adapted to the particular anatomy of
each patient, are tremendous. In the future, we will refer
to “cell cartridges” and “organ printers”!
44
Remote storage or cloud computing is another great
revolution in today’s industries, including healthcare. Although a secure cloud is possibly the greatest demand of
the health sector, in general, this technology can greatly
contribute to the advancement of ICT and be widely implemented in healthcare. Hybrid public/private clouds that
are immediately available whenever and wherever needed,
regardless of where the data are stored, can be powerful
tools for professional work. The paradigm shift from ownership of resources to availability of services (e.g., Software
as a Service) radically changes the approach to business in
the health sector, helping to implement concepts such as
availability of relevant clinical information at the point of
care or effectively build unique electronic health records10.
One key issue, however, is the necessary synchronisation
of information across all devices, systems, and media.
The Internet of Things11 refers to the 6,000 million
artefacts potentially connected to the Internet by 2015,
many of which are related to health and wellness. In conjunction with other technologies, the potential savings
from the use of remote monitoring and control systems
for the treatment of chronic diseases could reach 20%.
Moreover, their potential for application in other aspects of
care management, especially those related to quality, safety,
or productivity, is considerable. However, there is the risk
that devices in patients’ homes or personal networks can be
hacked or malfunction, which warrants the need to consider security and ethics. The Internet of Things enables concepts such as ambient intelligence, which will have much
influence on the health environment. The combination
of this technology with connectivity and miniaturisation
of sensors will expand its use exponentially in the coming
years. Like connectivity, Interoperability is necessary to
allow the predicted massive deployment of technology.
A concept that reflects both technological and sociological trends is “Bring Your Own Device” (BYOD)12. In the
health sector, this has obvious implications for security
and privacy, but it is spreading, aided by two factors: 1)
the near-universal availability of tablets, smartphones, or
similar devices and 2) the economic crisis, which minimises investments.
WHERE TO EXPECT NEW DEVELOPMENTS
Advances in the consolidation, analysis, and interpretation of big data will provide objective evidence that can
aid clinical diagnosis and treatment, care planning, and,
more importantly, produce a radical change allowing anticipation to the health evolution. This information will
be more valuable if it can be used to anticipate the occurrence of health events, either through the simple analysis of
large datasets, the use of algorithms, or the use of artificial
intelligence tools.
EWMA Journal 2015 vol 15 no 1
Scientific Communication
In contrast to today’s sporadic measurement of vital
signs, the immediate future leads us to continuous nonintrusive monitoring and control of physiological activities,
even in healthy individuals, in any place and under any
condition. Such monitoring can be performed through
embedded technologies that form an integral part of health
spaces or that even exist in our clothing, and such monitoring will in most part be transparent to the end user.
Another element of great importance for improving the efficiency of the health system as a whole has to
do with finding and using information. There will be a
breakthrough in the emergence of intelligent and focused
search engines that will be able to continuously provide
personalised information to patients based on their specific
conditions. Such information can be provided in a way
that encourages motivation, commitment, and adherence
to treatments and activities for self-management and selfcare, thus significantly increasing the ability of people to
make decisions in a more informed manner. Also, on the
service provider side, knowledge-based decision support
systems for qualified professionals will spread improving
availability of updated clinical evidence and resources
when needed.
People in the health system will not only participate as
individuals but also as members of a community.
We are transitioning from a system
focused and composed of individual health
professionals to one composed of health care
teams coordinated by a personal health
counsellor, who is not necessarily a medical
professional. Understanding that patients
are the centre of the health system serves to
drive this paradigm shift.
What to expect in wound care? Let’s expect technology
that will support more effective and secure care based on
anticipation and prevention rather than just cure, technologies that speed up healing through printed 3D skin
patches, better information systems for follow-up and
maintenance, and new collaborative tools that improve
communication and coordination among members of the
care team. An example of such an advance is smart surgical
sutures that are sensitive to temperature or infections and
are capable of sending information about wound status
from their micro-sensors, thus enabling a fast and efficient
response13.
Obviously, these advances will be distributed asymmetrically across our health system. As a result, the coexistence
of different levels of development and different stages of
implementation will undoubtedly lead to practical difficulties in day-to-day performance.
CONCLUSIONS
The aim of this short article was to convey the wide range
of opportunities and upcoming technological trends in
healthcare settings over the next few years. Healthcare professionals will enjoy greater patient participation and coresponsibility, technologies that are more helpful and easy
to use, more accurate and less invasive diagnostic tests, and
more personalised treatments. Above all, however, they will
have enhanced ability to anticipate, prevent, and perform.
In terms of sociological trends, we make note of empowerment, co-creation, sharing, online reputation, community, collective or mass intelligence, and the concept
of conversation.
Progress driven by technological and sociological trends
should flourish in sustainable health systems characterised
by high social support, efficiency, and the ability to adapt
to new circumstances, in which technology is no longer
just a tool but an indissoluble part of their development.
Will we be able to re-imagine (almost) everything? It will
be the only way to achieve a healthier future.
REFERENCES
1 Reig J. El Reto de la eficiencia en el sistema sanitario.
Las ideas de los expertos. Club GerTech, 2013. http://
www.clubgertech.com/wp-content/
uploads/2013/03/12636-El-reto-de-la-eficiencia-en-elsistema-sanitario-Las-ideas-de-los-expertos.pdf
[Accessed 23.10.14].
com/2011/01/30/transformational-technologies/
[Accessed 23.10.14].
2 Manary MP, Boulding W, Staelin R, Glickman SW. The
patient experience and health outcomes. N Engl J Med
2013;17;368(3):201-3.
6 Reeves, J. Transformational Technologies. Fool 2012.
http://www.fool.com/investing/general/2012/08/31/3transformational-technologies.aspx [Accessed
23/10/2014].
3 Lukas, H. Disruptive and Transformational Technologies. Robert H. Smith School of Business, University of
Maryland. http://blogs.rhsmith.umd.edu/lucas/
disruptive-and-transformational-technologies/
disruptive-and-transformational-technologies/
[Accessed 23.10.14].
4 Krugman, P. Transformational Technologies. The New
York Times 2014. http://krugman.blogs.nytimes.
EWMA Journal 2015 vol 15 no 1
5 Savitz, E. Gartner: 10 Critical Tech Trends For The
Next Five Years. Forbes 2012. http://www.forbes.com/
sites/ericsavitz/2012/10/22/gartner-10-critical-techtrends-for-the-next-five-years/ [Accessed 23.10.14].
7 Wikipedia. Big Data. http://en.wikipedia.org/wiki/
Big_data [Accessed 23/10/2014].
8 IBM Watson Foundations. IBM big data and information management. http://www-01.ibm.com/software/
data/bigdata/ [Accessed 23.10.14].
9 Zopf DA, Hollister SJ, Ohye RG, Green GE. Bioresorbable Airway Splint Created with a Three-Dimensional
Printer. N Engl J Med 2013;368:2043-5.
10Rouse, M. Software as a Service (SaaS). TechTarget.
http://searchcloudcomputing.techtarget.com/definition/
Software-as-a-Service [Accessed 23.10.14].
11Wikipedia. Internet of Things (IoT). http://en.wikipedia.
org/wiki/Internet_of_Things [Accessed 23.10.14].
12Healthcare IT News. Bring your own device (BYOD).
http://www.healthcareitnews.com/directory/byod
[Accessed 23.10.14].
13Kryska S, Grajek M, Rej A. A new weapon in the hands
of surgeons. Intelligent sutures. MEDtube. http://
medtube.net/
tribune/a-new-weapon-in-the-hands-of-surgeonsintelligent-sutures/ [Accessed 23.10.14].
45
Wound healing has always had villains.
Now it has a hero.
INFECTION
EXUDATE
BIOFILM
Our breakthrough new dressing attacks the key local barriers to wound healing, even biofilm.
TWO POWERFUL TECHNOLOGIES
Our proven Hydrofiber™ Technology absorbs and retains excess exudate to help create an ideal
healing environment.*1-5 And now our revolutionary new Ag+ Technology
destroys biofilm and kills infection-causing bacteria.*6-8
See how it helps you save the day at www.convatec.com.
No dressing does more.^
*As demonstrated in vitro
^Defined as the ability to manage exudate, infection and biofilm, as demonstrated in vitro
1. Newman GR, Walker M, Hobot JA, Bowler PG, 2006. Visualisation of bacterial sequestration and bacterial activity within hydrating Hydrober™ wound dressings. Biomaterials; 27: 1129-1139. 2. Walker
M, Hobot JA, Newman GR, Bowler PG, 2003. Scanning electron microscopic examination of bacterial immobilization in a carboxymethyl cellulose (AQUACEL™) and alginate dressing. Biomaterials;
24: 883-890. 3. Bowler PG, Jones SA, Davies BJ, Coyle E, 1999. Infection control properties of some wound dressings. J. Wound Care; 8: 499-502. 4. Walker M, Bowler PG, Cochrane CA, 2007. In vitro
studies to show sequestration of matrix metalloproteinases by silver-containing wound care products. Ostomy/Wound Management. 2007; 53: 18-25. 5. Assessment of the in vitro Physical Properties
of AQUACEL EXTRA, AQUACEL Ag EXTRA and AQUACEL Ag+ EXTRA dressings. Scientific background report. WHRIA3817 TA297, 2013, Data on file, ConvaTec Inc. 6. Physical Disruption of Biofilm by
AQUACEL® Ag+ Wound Dressing. Scientific Background Report. WHRI3850 MA232, 2013, Data on file, ConvaTec Inc. 7. Antimicrobial activity and prevention of biofilm reformation by AQUACEL™ Ag+
EXTRA dressing. Scientific Background Report. WHRI3857 MA236, 2013, Data on file, ConvaTec Inc. 8. Antimicrobial activity against CA-MRSA and prevention of biofilm reformation by AQUACEL™ Ag+
EXTRA dressing. Scientific Background Report. WHRI3875 MA239, 2013, Data on file, ConvaTec Inc.
®/™ Indicates trademarks of ConvaTec Inc. ©2014 ConvaTec Inc. AP-014181-MM
Scientific Communication
adrid · Spain
EWMA n GNEAUPP 2014
Submitted to EWMA Journal, based on a presentation given at a free paper
session (Free paper session: Quality of life) at the
EWMA - GNEAUPP 2014,
Madrid
A patient-led approach
to product innovation in
patient education and
wound management
ABSTRACT
This paper reports results from a multi-disciplinary
industry-academia research partnership whose goal
was to conceive, design and prototype solutions for
older adults with chronic wounds.
Aim: The aim of the project was to explore the potential enhanced benefits of extended patient involvement
in an entire live product development process, from
understanding the wound care environment, through
needs identification, to solution generation and iteration.
Methods: An action-design research methodology
was used to engage with 47 target users and develop
design ideas and prototypes. The research was built
around a theoretical framework that integrates aspirations and needs of target users with socio-technical
systems thinking and innovation management processes.
Results: The design component of the research methodology resulted in the concept design of a wound
management education and information system for
use by patients and their caregivers. This concept was
developed based on observations of and interaction
with patients and caregivers. A prototype solution was
built and used as a vehicle to gain an understanding of
opportunities, issues, and challenges to be addressed
in supporting older adults with chronic wounds and
enabling them to maintain and improve their personal
wellbeing. This led to the identification of the need
for readily available, current wound care information,
advice, and support for older people and caregivers.
The design concept was a response to this need. From
early evaluations of a prototype implementation, age
was identified as not necessarily being a barrier to
the use of a technology-based solution; IT skills, confidence, and access to the internet were identified as
more important factors.
Outcomes: A prototypical wound care information
system was developed that has been evaluated with
target users using deliberative panels and home-based
evaluations of a prototype implemented on a tablet
platform. Wound care solutions focussed on the
need to support people in maintaining their personal
wellbeing lead to different requirements from those
that support wound treatment. By considering wider
perspectives, solution providers have opportunities to
utilise fewer or re-allocate resources whilst improving
user wellbeing by creating user-focussed outcomes
that are effective, efficient, and valued by both patient
and provider.
INTRODUCTION
Policy developments in the UK resulting from the Health & Social Care Act1 prioritise the adoption of a proactive approach to patient involvement in service and
product innovation in healthcare. The “user pull” this creates aligns with innovation
theories2 that emphasise the importance of understanding user and market needs in
addition to technologies that could be used to create solutions. Within industry,
the importance of customer insight is increasingly recognised, and growing numbers
of companies in the medical technology sector are looking to open innovation as
a key approach to drive future growth3. However, currently less than one third of
medical technology-based solutions have been co-created with customers or external
partners4. 
EWMA Journal 2015 vol 15 no 1
Elaine McNichol1
Alison McKay1
Christine Milligan2
Kate Bennett3
Rod Hulme4
Heather Joy5
1 University
of Leeds, Leeds LS2 9JT, UK
2 University of
Lancater, Bailrigg,
Lancaster LA1 4YW, UK
3 University of Liverpool,
Liverpool, Merseyside L69 3BX, UK
4 Smith & Nephew, 15
Adam Street, London, WC2N 6LA
5 Hull City Health Care
Partnership CIC, 5 Beacon
Way, Hull, HU3 4AE, UK
Correspondence:
[email protected]
Conflicts of interest: None
47
In addition to achieving user pull, a further challenge in
creating such solutions lies in understanding the organisational context in which solutions are to be introduced.
This is especially the case when introducing information
and communications technology (ICT)-based solutions,
where failure is often associated with social dimensions of
the environment in which they are introduced and with
interactions between social and technical dimensions5,6.
With solutions intended for use in patients’ homes, the
importance of close interaction with patients and of integrating solutions within the broader patient experience
and home environment is even higher. This research used
a socio-technical systems framework7 as a means of gaining
these insights both in the early stages of the design process
and in the evaluation of prototype solutions.
The problem of older adults living with chronic wounds
was selected as a case study because of the challenges involved in supporting this population to allow them to
live independently, thereby improving their quality of life
and wellbeing. Solutions were conceived, designed, and
prototyped. The specific focus on development of innovative internet/e-technology-based solutions was identified
early in the process, during which patients highlighted the
importance of being able to manage, rather than cure, their
wounds. The approach used both educated researchers
and clinical experts, and addressed issues of both personal
wellbeing and clinical health, driven by a philosophy of
patient-identified need.
BACKGROUND
There is a tension between the primary focus of clinicians, industry, and healthcare organisations with regards
to cure and compliance, and the importance to patients
of the everyday impact of living with a wound and the
requirements of innovations that will address their sense
of wellbeing8. At the same time, there is increased recognition within the NHS in the UK, for example, of public and patient involvement both in research and in the
design and delivery of services9. This creates a challenge
in identifying, hearing, and maintaining the voice of the
patient amongst the plethora of multi-professional voices.
These competing commitments informed the rationale for
beginning with the patient perspective, thereby ensuring
that this perspective was the inspiration for the innovation
process, and that it would continue to be involved and
influence at critical stages of development.
The importance of user pull in successful innovation
processes is increasingly recognised10. ICT-based systems
and solutions can provide the “pull” from patients and
caregivers for greater innovation by enabling patients and
caregivers to make informed choices about which interventions they would like to receive and take responsibility for
48
in managing their own care. Patient and caregiver demand
is an important driver for the adoption of technology as
they become more empowered and more demanding
about the kinds of treatment they want. Patients may
not be able to specifically articulate an innovation, but they
can describe their basic needs and their basic expectations
of wound care management solutions. The aim of this
project was to explore the potential enhanced benefits of
extended patient involvement in an entire live productdevelopment process, from understanding the wound care
environment, through needs identification, to solution
generation and iteration.
METHOD & RESEARCH PROCESS
An action-design research methodology was used11. Core
aspects of the methodology were engagement with users
through the whole process (before any solutions were proposed) and the use of design sketching and prototyping
as a means of quickly exploring and evaluating potential
solutions, broadly illustrated in Figure 1.
Figure 1. The design and development process
As preparation for the cycle, a desk-based analysis of patient
and other stakeholder needs, informed by a socio-technical
systems thinking approach to innovation and management
processes5 , was carried out. This was combined with the
concept of using design to create self-perpetuating Virtuous Cycles of Wellbeing12. The research team engaged
with 47 older people with a focus on the key experience
of “living with” a chronic wound.
The more detailed research process, illustrated in Figure 2, began with a study of the problem domain, which
included a desk-based study and discussions with wound
care professionals, and a literature review of innovation
systems in the wound management domain. This ensured
that all academic participants had a basic awareness of issues and current practices in the management of wounds.
Two series of half-day workshops were then carried out.
These workshops involved 15 selected urban, communitybased, ambulatory, and wheel-chair bound patients and
caregivers with a history of wound care, and an ability to
articulate their stories, experiences, and needs gained from
EWMA Journal 2015 vol 15 no 1
Scientific Communication
of community-based patients and caregivers, again, from
training they had previously received from the University
both urban and rural settings. The prototype was impleof Leeds. The results of this preliminary work, in terms
mented as semi-functional software on a hand-held device,
of how meaningful it was for patients and their caregivers,
in order to allow the patient and caregiver to develop a betwere evaluated at the beginning of the first action design
ter feel for a potential live solution. The research took the
research workshops. This led to a shared understanding of
form of one-to-one or one-to-two interviews, conducted
patient and caregiver perspectives on living with a chronic
by a project team member, either in the patient’s home or
wound and highlighted differences in priorities of different
a neutral health-related environment.
stakeholders within chronic wound care systems where
patients and caregivers place more value on living well
With the exception of the Design team (ex-students), all
(e.g., no discomfort related to compression stockings and
activity was conducted by project team members and asbeing able to wear shoes that are comfortable, aesthetically
sociates drawn from the initial academic, health provider,
pleasing, and odour free13) rather than healing the wound.
and industry participants. Feedback on the process was
Outputs from these workshops were in the form of lowobtained from the team members.
fidelity prototypes of possible solutions and their pros and
cons. Results from the initial study and the workshops
were passed to a professional design team to inform the
RESULTS
development of five concept designs with an IT interface
The key results of the project are split into two areas of
but with no functionality. These concepts were evaluated
focus:
in a second series of patient-led workshops held in both
1. The benefits of extended patient and caregiver
an urban and a rural environment with ambulatory and
involvement in the product development process.
wheelchair-bound community-based patients and caregiv2. The final design concept definition as shown in
ers less familiar with articulating their needs.
Feedback on both the product solutions and their involvement in the development process was Figure 3.
Based upon the qualitative and quantitative feedback from
obtained from the participating patients and caregivers. the
workshops, specified concept selection criteria were
It can be seen that the final concept was an education and
used
to select the final concept for further development.
The final result from this phase of the research was the definition of a concept that was then wound management information system informed by isFeedback on both the product solutions and their inimplemented as a prototype that could be evaluated with a wider range of community‐based patients sues that patients and caregivers said were important to
volvement in the development process was obtained from
and caregivers, again, from both urban and rural settings. The prototype was implemented as semi‐
them. Appropriate expert advice on relevant topic-related
the participating patients and caregivers.
functional software on a hand‐held device, in order to allow the patient and caregiver to develop a issues was included along with advice on management,
The final result from this phase of the research was
better feel for a potential live solution. The research took the form of one‐to‐one or one‐to‐two support and personal goal setting, self-monitoring and
the definition of a concept that was then implemented
reporting of wound profile (self-assessment) capabilities,
asinterviews, conducted by a project team member, either in the patient’s home or a neutral health‐
a prototype that could be evaluated with a wider range
related environment. Understand the problem situation
Desk‐based study of wound care user needs & requirements
Discussions with wound care professionals
Literature review of wound management innovation systems
Research results
Preliminary design workshops
Design development workshop with patients & carers Five Professional concept design designs development of concepts
One concept selected for development
Professional design development of final concept
Final design concept
definition
low fidelity Review problem prototypes understanding with patients & carers Concept development & evaluation with users in rural settings
Prototype development & evaluation with users in urban settings
Figure 2. Flow chart of the research process
Figure 2: Flow chart of the research process EWMA Journal 2015 vol 15 no 1
49

n
USING TECHNOLOGY
IT skills, confidence, and issues of access were all pertinent
to the potential value and impact of the system and were
addressed by creating an easy-to-use system that could be
deployed on multiple platforms.
Ease of access to expert information and personal
wound history as and when needed was seen as empowering and enabling individuals to make decisions
and live their lives more independently, an important
component of “wellbeing.” However, there was some
concern that the technology might mean less input
and support from the clinicians and by default more
work and responsibility for the management of the
wound by the patient. The importance of practitioner
contact was emphasised by participants and seen as
an enabler for technology adoption. This tension is
not limited to wound management; it is also reflected
in the wider self-management literature14,15.
n The recognition that age need not be a barrier to the
use of technology. More important was that the tech nology was described as easy to use, and because it had
followed the KISS ‘keep it short and simple’ principle,
that it overcame any anxieties individuals may have
had due to either a lack of familiarity with IT technol ogy or to lack of physical dexterity.
Among practitioners, views differed between social care
and healthcare professionals; social care professional tended to feel that the solution increased empowerment and
independence, whereas healthcare professionals tended
to hold the view that many older people want to be cared
for rather than empowered, and raised concerns that additional monitoring may increase their workloads and that
changes in patient and practitioner roles reduced the need
for their professional expertise. In discussions considering how these concerns might be addressed, the use of
the solution as a “safety net” and a “red flag” system was
positively received.
The design was generally regarded as strong, however, in
developing it further, a number of technical issues would
need to be addressed. For example, methods for caregivers and patients to measure wounds would be needed,
as would easy-to-use means of capturing lifestyle-related
information, such as nutrition, exercise, and rest. Patients
and caregivers recognised the importance of a good diet
and exercise, but also identified that the impact of the
wound was that “exercise can often be difficult and painful. Anything to help with and monitor exercise would
be very beneficial.” (Patient quotation).
ISSUES IDENTIFIED AS IMPORTANT BY
PATIENTS INCLUDED:
n Trust in the confidentiality of the system, that is, that
they could access information as and when they want ed to as well as record information specific to their
wound that would only be accessible to themselves
and to the healthcare professional. A real fear existed
with patients that technology-enhanced care meant
that their details could be “hacked.”
DISCUSSION AND FUTURE OPPORTUNITIES
The research reported in this paper is part of a wider research initiative with a long-term goal of creating effective
and efficient ways of engaging with the users of health and
social care systems and with a goal of generating meaningful “user pull” to inform the programmes of change that
are being introduced in response to challenges arising from
the ageing population. The methodology and process used
are outlined in Section 2; a more detailed paper on the
!
Figure 3. Design concept
!"#$%&'K8'=&-"#.'62.6&35
!
!
information on and suggestions for exercise and diet, and
links to other potentially useful resources. This addressed
a number of issues that patients and caregivers identified
and other key stakeholders recognised.
LACK OF READILY AVAILABLE CURRENT
WOUND CARE INFORMATION, ADVICE, AND
SUPPORT
A key benefit to patients and caregivers was that the design
overcame a problem described by one patient as “There is
not a lot of care information available other than a simple
leaflet and basic information from district nurses.” Patient focus groups emphasized that information and advice
were not readily available or understandable, and that they
were unable to determine if the advice was appropriate for
themselves and the care they required. The approach to
wound management embedded within the design enables
patients to access information when required, as opposed
to having to remember it from when it was provided, and
allows caregivers and family members to easily access this
information.
50
EWMA Journal 2015 vol 15 no 1
Scientific Communication
methodology is currently in preparation. However, key
features of the process are engagement with users through
the entire process and the use of design prototypes to help
build a shared understanding of both the problem and the
proposed solution, and to identify further development
opportunities.
A key feature of the action design research methodology
is that it benefits both the researcher, by generating new
knowledge, and the system users (patients and caregivers),
through the resulting solutions. The solution reported
in this paper has the potential to lead to a reduction in
treatment costs through more appropriate use of clinical
appointments. The on-line tool would help inform decision making about whether to request an appointment
with a clinician, thereby reducing potentially unnecessary appointments and saving patients time and resources
by their not having to either stay at home waiting for a
visit or travelling to a clinic. By capturing more holistic
information, such as diet, exercise, support, and broader
well-being issues, in addition to wound-specific issues,
individually-designed treatment plans can be created.
From a process perspective, patient-led identification
of needs requiring solutions may identify different priorities to the professionals. Ensuring innovations are fit
for purpose and acceptable (i.e., usable, affordable, and
wanted) to the patient/caregiver makes them more likely
to be adopted, thus speeding up the adoption process of
appropriate innovation. Innovations are tailored with
patients and caregivers to meet their needs, recognising
their unique insights and embedding the inclusion of their
perspective throughout the development process to ensure
that the end product delivers on the initial identified need.
A “patient-led” approach moves beyond the principle
of “patient involvement.”16 It demonstrates a commitment to the concept that the patient has a different but
equally valid expertise that should be heard and inform
service and treatment innovation. The inclusion of the
patient voice at all stages of the innovation process fosters
an “on-going” relationship and helps to address the issue
of tokenistic involvement. In this instance, the context
has been wound care, but the principle and practice of a
patient-led approach to product and service innovation
is transferable to other health conditions and contexts.
CONCLUSIONS
The aim of the project was to explore the potential enhanced benefits of extended patient involvement in an
entire live product development process.
It is clear from the findings that patient and caregiver
participation in the product development process brings
benefits to understanding the issues that are important
to patients’ health and well-being, co-creating potential
solutions that address those issues and thereby potentially
improve clinical outcomes and use of clinical resources,
and tailoring technical requirements to ensure product
innovations are fit for purpose in the lived world of the
patient as well as in the laboratory.
Involving patients and caregivers in selecting product
concepts is not new, but rigorously involving them all
the way through the product development process from
concept through prototyping and ultimately to marketing
is not common and is a practice that this project suggests
is advantageous.
Recommendations for practice:
n Recognise the patient and caregiver’s expertise of lived
experience and respond to it with the same respect as
to a clinician’s or technologist’s expertise.
n Invest time in understanding the patient and caregiver
experience of wounds and innovating new products
and services in response to that insight.
n Involve patients and caregivers at the beginning and through all key stages of innovation development to ensure a good idea becomes a good product or service.
REFERENCES
1. Health and Social Care Act 2012, c.7. Available at:
http://www.legislation.gov.uk/ukpga/2012/7/contents/
enacted (Accessed: 8 January 2015).
6. Clegg C, Shepherd C. The biggest computer
programme in the world… ever!’: time for a change in
mindset? J Inform Technol 2007;22:212-21.
2. Rogers EM, Medina UE, Rivera MA, Wiley CJ.
Complex adaptive systems and the diffusion of
innovations. Innov J 2005;10:1-26.
7. Clegg CW. Sociotechnical principles for system
design. Appl Ergon 2000;31:463-77.
3. Greenhalgh T, Robert G, MacFarlane F, Bate P,
Kyriakidou O. Diffusion of Innovations in Service
Organizations: Systematic Review and Recommendations. Milbank Q, 2004;82:581–629.
4. Price Waterhouse Cooper Health Research Unit
(2013) Medtech companies prepare for an innovation
makeover. www.pwc.com/hriwww.pwc.com/us/
healthindustriestwitter.com/PwCHealth. (accessed
01.05.14)
5. Clegg CW, Gray MO, Waterson PE. The charge of the
‘ByteBrigade’ and a sociotechnical response. Int J
Hum Comput Interact 2000;52:235-51.
EWMA Journal 2015 vol 15 no 1
8. Anon 2012. International consensus. Optimising
wellbeing in people living with a wound. An expert
working group review. London: Wounds International.
9.http://www.england.nhs.uk/ourwork/patients/
[Accessed 01.04.15]
10. Or CKL, Karsh BT. A Systematic Review of Patient
Acceptance of Consumer Health Information
Technology. J Am Med Inform Assoc 2009;16:550–
60.
11. Sein M, Henfridsson O, Purao S, Rossi M, Lindgren R. Action Design Research. MIS Q, 2011;35: 37-56.
13. McNichol E. Involving patients with leg ulcers in
developing innovations in treatment and management
services. Br J Community Nurs 2014;19(9 Suppl):27-32.
14. Bayliss EA, Steiner JF, Fernald DH, Crane LA, Main
DS. Descriptions of Barriers to Self-Care by Persons
with Comorbid Chronic Diseases. Ann Fam Med
2003;1(1):15-21.
15. Blakeman T, Protheroe J, Rogers A, Chew-Graham
C, Kennedy A. Understanding the management of
early-stage chronic kidney disease in primary care: a
qualitative study. Br J Gen Pract 2012;62(597):e23342.
16. McNichol ED. Patient Led Innovation in Healthcare
- The Value of The User Perspective. Int J Healthc
Manag 2012;5(4):216-22.
12. Wartman SA. Toward a virtuous cycle: The changing
face of academic health centers. Acad Med
2008;83(9):797–9.
51
BeneHold TASA Wound Dressing
®
®
See Healing
Exceptionally transparent, thinner than any other generation of absorbent skin adhesive,
and surprisingly absorbent for its size, BeneHold® TASA® (Thin Absorbent Skin Adhesive®)
provides an innovative window into the healing process.
Combined Properties, Distinct Benefits
+
+
+
=
Transparent
Absorbent
Comfortable
Ultra Thin
TASA® remains clear
even as it absorbs fluid
TASA® technology
provides improved
fluid handling
Conformable and
atraumatic, improving
the patient’s experience
Hydrocolloid
performance at just
0.12 mm thinness
Fewer
Dressing
Changes
Helps Lower Cost of Care • Promotes Better Time Management • Can Improve Results
Join us for our Symposium,
See Healing: Transparency,
a Key Factor in the Treatment
of the Neuropathic Foot Ulcer
to learn more about BeneHold® TASA®,
Friday, May 15, 12:20-13:20
in room South Gallery 13-14.
An Avery Dennison business
© 2015 Avery Dennison Corporation. All rights reserved. Avery
Dennison, Vancive Medical Technologies, Vancive, BeneHold, TASA,
Thin Absorbent Skin Adhesive, and Design “V” Logo are trademarks
of Avery Dennison Corporation. Data is on file for all above claims.
MTR-MKT-000154-A
Aspen Medical Europe Ltd., a part of the Hill-Rom Corporation,
is the official distributor of Vancive’s BeneHold® TASA® and the full range of
BeneHold® products in the United Kingdom and Ireland. For more info,
please contact ‘Customer Care’ on Freephone: 0800 032 3399, email
[email protected], or visit www.aspenmedicaleurope.com.
Scientific Communication
European perspectives
on biomaterials for
health
Fergal Donnelly
MD FFPM,
Directorate‑General for
Research & Innovation,
European Commission,
B‑1049 Brussels,
Belgium.
Correspondence:
Fergal.DONNELLY@
ec.europa.eu
Conflicts of interest: None
54
ABSTRACT
Biomaterials for health will become a major focus of European research efforts in the
coming years and as part of the Horizon
2020 Framework Programme for Research
and Innovation. They will find applications
particularly as integral parts of Advanced
Therapy Medicinal Products (ATMPs) or,
indeed, as complete or parts of Medical Devices. The relevant regulations that govern
the marketing of these entities must be taken
into consideration when planning research
and development, and various incentives and
assistance in that regard are available from
regulators.
INTRODUCTION
Most new technical innovations are directly or indirectly linked to the increasing use of specialised materials, which is forecast to continue rising steadily until
at least 2030. The Materials Summit of 2012 brought
together a wide range of representatives of the leading
industrial and research parties to put together a broad
strategic vision of research and development activities
for the eventual deployment of specialised materials.
This is intended to generate and maintain the growth,
competitiveness, and sustainability of European industry to foster economic activity and employment
possibilities along with improved living standards for
European citizens1.
At the same time, the bio-based markets with high
demand, especially in the field of human healthcare,
and with complex yet favourable legislative frameworks have the potential to make a substantial contribution to transform the European economy into one
that is more sustainable and competitive in nature. In
this context, there is a need for specific partnerships
between the private and public sectors, building on
corporate responsibility to facilitate greater transparency and accelerated access to new therapeutic interventions in the healthcare field, whilst at the same
time rewarding innovation and enhanced industrial
competitiveness2.
An integrated approach to research, development,
and innovation actions is therefore anticipated3. In
this way, novel materials should be devised at the same
time as the creation of new products of which the
materials are intended to be an integral part. Processing should also be addressed, thus ensuring both the
novelty of the developed solution and the rapidity of
the solution’s industrial take-up. Among the specific
areas of interest that have been identified as priorities
for action is biomaterials for medical applications, for
EWMA Journal 2015 vol 15 no 1
Scientific Communication
which a Strategic Roadmap for Research has been proposed1, 4.
BIOMATERIALS FOR HEALTH
Biomaterials are examples of Advanced Materials5, because
they can offer major improvements in a wide variety of
different fields, including healthcare. In the health field,
biomaterials often become part of or an entire living structure, either alone or in combination with another biomedical entity in order to perform, augment, or replace
a natural function. They might be non-interactive with
their environment, such as the case of a heart valve, or
possess a more interactive functionality, such as the case
of drug-impregnated stents that release pharmaceutical
products. More recently, biomaterials have been used to
facilitate the operation of Medical Devices6 and Advanced
Therapy Medicinal Products (ATMPs)7 over prolonged
periods of time.
According to various forecasts and estimates, the size of
the global biomaterials market is expected to reach €100
billion by the year 2020, increasing from a mere €20 billion over the preceding 15 years with a Combined Annual
Growth Rate (CAGR) of between 10% and 15%. Increased investment of a public and private nature, technological advances, greater scope for the use and deployment
of biomaterials, and an ageing population – who are by far
the greatest users of biomaterials – are the major factors
that will promote the global biomaterials market growth.
However, major deterrents that negatively impact the
biomaterials market include immunological and inflammatory reactions, stringent regulatory systems, reimbursement, and the biomechanics issues of fracture, fatigue,
and wear. The global biomaterials market is dominated
by North America, followed by Europe, Asia, and the rest
of the world. North America is expected to continue to
lead the biomaterials market in the years to come, followed by Europe. The European market is characterised
by a fragmented picture that affects all sectors: national
pricing policies and reimbursements offered by healthcare
maintenance organisations, national research and innovation policies, etc.
From a technological perspective, the biomaterials market is expected to experience growth due to large increases
in the demand for new products that have to interact
with their environment in specifically tailored ways. This
especially applies to products that are expected to modify
the body’s natural reactions to promote tissue and organ
regeneration, the so-called “smart biomaterials”. Currently,
this field relies largely on the use of “non-smart” biomaterials, which include the traditional categories of polymers,
metals, ceramics, and composites. These only partially
fulfill clinical needs by:
EWMA Journal 2015 vol 15 no 1
n
Replacing damaged tissues and organs (i.e. medical implants)
n Treating diseases through the controlled administration
of drugs (i.e. drug carriers)
n Facilitating diagnosis and monitoring (i.e. contrast
agents and biosensors)
The currently available biomaterials suffer limitations,
leading to reduced longevity (medical implants) and a lack
of biospecificity (biosensors, drug carriers, and contrast
agents).
The need to develop biomimetic and bioresponsive
biomaterials is therefore widely recognised, as this approach offers solutions both for Advanced Therapies and
for improved longevity of Medical Devices. This will need
to be a major research and development focus in the future, with innovation being the key to success. Indeed,
the body’s internal environment can be simulated by synthetic materials to support tissue-repair processes and to
facilitate the cell-specific recognition processes required for
bio-targeted drug delivery or imaging. Likewise, biomimetic, bioresponsive biomaterials are widely recognised as
prerequisites for the future implementation of cell-based
therapies. Major biomaterial breakthroughs in the coming
years should address specific needs, such as the enabling
the ability to control the phenotype of mesenchymal stem
cells in culture.
The major quantum leap for the short to medium-term
future is to move away from merely replacing a natural
function towards promotion of the body’s capacity for selfhealing, thereby facilitating the regeneration and renewal
of the body’s own functions. This might mean modulating
an immune response that already exists in an organism to
allow other actions to follow, such as the infiltration of a
diseased organ with an Advanced Therapy Medicinal Product (ATMP) or a Medical Device so as to repair damaged
tissue. Collectively, the ability of biomaterials to adapt
to their environments in a beneficial manner, referred to
as biocompatibility, will in no small part determine the
success of the therapeutic interventions with which the
biomaterials are associated. This particular aspect of interactive or smart biomaterials is expected to be a major
area of growth for research and development activities in
Horizon 2020 and can help to move research out of the
“Death Valley” and into commercially viable solutions.
The rational design of smart biomaterials therefore cannot be considered unless a better understanding is achieved
of the in vivo perturbation of the biological environment,
drug delivery, the mechanisms of biomaterial degradation
and fate, and the control of tissue-biomaterial interaction.
In particular, the importance of controlling any inflammation process has been highlighted in a tissue-regeneration
context as being of paramount importance. Research will
also need to focus on biomaterials that can be adapted to
55

non-invasive clinical protocols through the concepts of
injectability, self-assembly, and bio-responsiveness. This
approach is becoming crucial for the diagnosis, management, and treatment of critical pathologies such as neurodegenerative disorders (e.g. Alzheimer’s disease, Parkinson’s
disease, and multiple sclerosis) as well as cardiovascular
disorders, cancer, diabetes mellitus, and others.
REGULATORY AFFAIRS
In undertaking research actions involving biomaterials that
will become part of Medical Devices or ATMPs, regulatory requirements should be considered, even in basic
research projects in which new biomaterials are developed
from zero. This means that possible applications and their
implications in terms of regulation should be set out in
detail. Regulatory experts should be involved in the basic
research activities undertaken by consortia to raise awareness of the implications of research decisions in terms of
the regulatory path to be followed.
Regulation should not be looked at in isolation but as
a factor contributing to the acceptability to the healthcare
system of the products containing smart biomaterials. A
clear regulatory path should be set out as a requirement for
proposals to be considered for funding. The requirements
for evidence of safety and efficacy do not come only from
regulators but also from the end users and payers. This
comprises the full value chain from “bench to bedside”,
including the manufacturing sector, where scaling up of
production is an important consideration. As a part of
this exercise, it will also be necessary to develop a new and
better methodology for standardisation, safety assessment,
and clinical evaluation and to help to take appropriate
stock of innovative scientific advances as and when they
occur. This will not in any way replace the current systems
of regulatory approval.
The main regulatory processes that concern Medical
Devices and ATMPs are the relevant European regulations
currently in force that govern these fields6,7.
n
The new environment of the overall regulatory process
for medical devices has important implications for future
research and development in the field, including biomaterials.
As a result of this package, several measures will be
introduced to ensure the traceability and transparency of
the devices and their ingredients, which will have important consequences for the biomaterials that may be a part
of the devices. They will be required to bear a European
Unique Device Identification (UDI), identifying the specific product type and batch, and all operators must be
able to identify all those involved in the supply chain. A
number of major questions need to be integrated by future
research projects with the aim to translate into eventual
clinical use. These will concern conformity assessment,
surveillance audits, testing, and inspections and also more
detailed requirements addressing pre-market clinical evaluation and post-market clinical follow-up. The adaptation
of classification rules and risk-classification procedures
and the reinforcement of clinical evidence requirements
all contribute to a more complex regulatory scenario for
medical devices in Europe.
ADVANCED THERAPY MEDICINAL PRODUCTS
In the case of Advanced Therapies (and the biomaterials that are parts thereof ), which is the larger of the two
fields of potential application, Small and Medium-sized
Enterprises (SMEs) that develop these products for human or veterinary use may avail themselves of various
incentives that are provided by the European Medicines
Agency (EMA), which regulates their marketing in the
EU. These comprise:
n
n
MEDICAL DEVICES
In the field of Medical Devices, the European Commission adopted a package on innovation in health on 26
September 2012, consisting of :
n
n
n
The Communication on safe, effective and innovative
medical devices and in vitro diagnostic medical devices
for the benefit of patients, consumers, and healthcare
professionals8
n The Proposal for a Regulation of the European Parlia ment and of the Council on medical devices, and
amending Directive 2001/83/EC, Regulation (EC) Nº 178/2002 and Regulation (EC) Nº 1223/20099
56
The Proposal for a Regulation of the European Parliament and of the Council on in vitro diagnostic medical
devices10
n
n
Administrative and procedural assistance from the
SME office
Fee reductions for procedures in the pre and postmarketing authorisation phases, including scientific
advice, inspections, line extensions, and variations
Fee exemptions for certain administrative services of
the EMA
Deferral of the fee payable for an application for
marketing authorisation or related inspection
Conditional fee exemption when scientific advice is
followed and a marketing authorisation application is
not successful
Assistance with translations of the product-information
documents submitted in the application for marketing
authorisation
EWMA Journal 2015 vol 15 no 1
Scientific Communication
n
Waiver of the MedDRA licensing fee when registering
with EudraVigilance; this is only available for micro
or small-sized enterprises and not for medium-sized
enterprises
n Inclusion in the public SME register
These incentives can include a 90% reduction in the
total applicable fee charged for scientific advice given regarding applications for ATMPs for human use, a 90%
reduction to the total applicable fee for non-orphan medicinal products, and either a deferral of the total applicable
fee or a conditional fee exemption for an application for
a Marketing Authorisation. Further details are available
from the EMA11.
WOUND HEALING
Biomaterials are used most frequently as part of medical
devices, for example, as fracture-fixation devices, internal
tissue sealants, surgical haemostats, adhesion barriers, and
skin substitutes. Collectively, this domain is expected to be
one of the better performers in terms of market growth,
with an expected overall combined annual growth rate
in the region of 17.8% in the five years ending in 2017.
Plastic surgery and the increase in diabetic ulcers, resulting
from ageing and diabetic populations, are the main drivers
for this growth. Interestingly, this growth is expected to
be greatest not in North America or Europe, but rather
in Asia12.
One of the fields for ATMPs is tissue engineering, which
is expected to be the focus of new developments in wound
healing in the coming years. Biomaterials that facilitate
its operation are therefore expected to enjoy a significant
upsurge in demand for use in applications where skin and
tissue regeneration is desirable. A particularly interesting
example of this is chitin, which has high biocompatibility along with a wide range of potential functions, such
as accelerated skin repair, immunostimulation, and the
stabilisation of drug components intended for delivery.
Another example of an Advanced Therapy that will require
similar biomaterials for their effective deployment and use
in wound healing is stem cell therapy, which is presently
largely confined to autograft use in emergency situations
when other solutions are not available.
Given the fragmented nature of European research activities, an integrated approach at the European level is
crucial to overcome the new technical challenges that lie
ahead and to take advantage of the consequent possibilities
for market growth and expansion. The various stakeholders who are involved from research through innovation
and eventual market placement will need to be pooled
to allow for the increased up-scaling of production and
financial risk sharing and the simultaneous optimisation
EWMA Journal 2015 vol 15 no 1
of the use of available knowledge and resources. A better
focus on research and development priorities through the
definition of a strategic research agenda in consultation
with stakeholders would thereby ensue. A more competitive private sector to drive economic growth can flourish.
Within this context, there could be the means to address
topics such as the regulation and standardisation that require a neutral/multi-stakeholder environment. This will
provide for better long-term benefits at the bedside, in the
form of shorter waiting times for new therapeutic interventions, that reflect the best of the state of the art at an
affordable price, not just for patients but also for healthcare
systems overall.
EDUCATION & TRAINING
The need for and imminent arrival of smart biomaterials
for health pose a particular challenge in the field of education and training, which is somewhat unprecedented in
that it requires a combination or merging of research efforts of a clinical nature with those of a more fundamental
or laboratory-based nature. This means the development of
a broadly accepted career path, based on defined cognitive
learning alongside on-the-job experience, for both physicians and non-physicians to become a registered specialist
in biomedicine. There is also a need for the acquisition
of other skills of a non-scientific nature, such as those in
economics, regulatory affairs, ethics, management, business administration, and law. In addition, the structure of
undergraduate medical degree courses is such that there is
little or no time dedicated to the acquisition of research
skills. This contrasts sharply with the post-graduate sphere,
whether clinical or non-clinical, where a major emphasis is
placed on carrying out and eventually publishing research
in order to acquire credibility in a given therapeutic field.
The main obstacles that need to be overcome are:
n Design appropriate curricula with appropriate oppor tunities for interdisciplinarity as well as the possibility
of research as a long-term career option.
n
n
Modernise resources and strategies to reflect new
developments and challenges related to healthcare
systems, which can thereby be rendered more attractive
for medical researchers.
Facilitate the mutual recognition of degrees and diplomas, thereby fostering better international collaboration, while at the same time maintaining the highest
possible clinical and quality standards.
n
Improve co-operation between academia and the

industrial and clinical sectors to facilitate practical
hands-on training.
Academic institutions that offer degrees and diplomas
related to medical research in all its forms, whether clinical
or non-clinical, should develop more numerous and more
active connections with a wide variety of public and private
stakeholders, both in their immediate regional environment and worldwide. These would comprise large and
small industrial companies, healthcare institutions, regulatory bodies, public administrations, research institutes,
and all other stakeholders with an interest in the research
and production of biomaterials for health. Common and
internationally accepted principles regarding research integrity can help to devise appropriate principles in this
regard, such as the Marie Curie Actions, the ERASMUS
Student Exchange programme, and various activities of the
European Science Foundation, which should be continued and expanded. This would result not only in greater
mobility and career choices but also in the acquisition of
practical skills and the facilitation of better responses to
the challenges that lie ahead.
In this regard, a major objective for Europe should be
the mutual recognition of post-graduate degrees and diplomas, along the same lines as those used for undergraduate
qualifications at present, which would preferably be endorsed by a recognisable pan-European higher education
authority. This should be based upon commonly developed
standards for the global recognition of credentials along
with the development of a pan-European career-tracking
scheme that can support the development of world-class
quality standards in the field of biomaterials research. Not
only will this support and consolidate the classification and
standardisation the different types of new and emerging
biomaterials, but it will also testify to the excellence and
overall competitiveness of European research institutions
and researchers and their mobility within the EU. Continuous professional development programmes for senior
medical researchers (i.e. those in pre-clinical disciplines)
as well as those in applied medical fields would necessarily
become part of this exercise.
The final overall product or deliverable would be an
internationally recognised MD-PhD diploma. This would
comprise the foregoing scientific and non-scientific elements as well as practical hands-on experience, leading to
the production of a memoir supervised and reviewed by
experts in the relevant pre-clinical and clinical fields that
would certify the results of the research carried out. Greater
mobility and career choices can therefore be expected, as
well as greater potential use of the practical skills thus
acquired.
CONCLUSIONS
The ultimate challenge to be addressed in the research and
development of biomaterials for health is the integration
required to overcome the “Death Valley” between laboratory-based research on the one hand and commercially
viable solutions that make a positive difference to the lives
of patients on the other. Regulatory requirements must be
considered, even in those basic research projects in which
new biomaterials are developed from the very beginning,
as these have implications not just for eventual applications
but also advantages and incentives available from regulators which can speed up the development process. This
emphasis on the practical application of research to meet
major societal challenges will help to improve existing research infrastructures and to make better use of research
results. The result will be to further strengthen innovation,
develop new activities, and boost the productivity and
competitiveness of the European economy.
REFERENCES
1. European Research and Innovation in Materials
Science and Engineering: What to change in the
future? Report from the Materials Summit in Brussels,
10 September 2012, 2013 Research and Innovation
EUR 25606, ISBN 978-92-79-27540-1
biomaterials-roadmap-for-horizon-2020_en.pdf
[Accessed 07.04.14]
2. Communication from the Commission to the European
Parliament, the Council, the European Economic and
Social Committee and the Committee of the Regions An Integrated Industrial Policy for the Globalisation Era
: “Putting Competitiveness and Sustainability at Centre
Stage” Brussels, 28.10.2010, COM(2010) 614 final
3. Communication from the Commission to the European
Parliament, the Council, the European Economic and
Social Committee and the Committee of the Regions :
“A European strategy for Key Enabling Technologies
– A bridge to growth and jobs”, Brussels, 26.6.2012,
COM(2012) 341 final
4. Biomaterials For Health - A Strategic Roadmap for
Research and Innovation - Horizon 2020, http://ec.
europa.eu/research/industrial_technologies/pdf/
58
vitro diagnostic medical devices for the benefit of
patients, consumers and healthcare professionals”
Brussels, 26.9.2012, COM(2012) 540 final
5. Communication from the Commission to the European
Parliament, the Council, the European Economic and
Social Committee and the Committee of the Regions :
“Preparing for our future: Developing a common
strategy for key enabling technologies in the EU”,
Brussels, 30.09.2009, COM(2009) 512 final.
9. Proposal for a Regulation of the European Parliament
and of the Council on medical devices, and amending
Directive 2001/83/EC, Regulation (EC) No 178/2002
and Regulation (EC) No 1223/2009: Brussels,
26.9.2012 COM(2012) 542 final 2012/0266 (COD)
6. Directive 90/385/EEC, regarding Active Implantable
Medical Devices, Directive 93/42/EEC regarding
Medical Devices and Directive 98/79/EC regarding In
Vitro Diagnostic Medical Devices.
10.Proposal for a Regulation of the European Parliament
and of the Council on in vitro diagnostic medical
devices (Text with EEA relevance) Brussels, 26.9.2012
COM(2012) 541 final 2012/0267 (COD)
7. Regulation (EC) No 1394/2007 on Advanced Therapy
Medicinal Products (Gene Therapy, Stem Cell Therapy
And Tissue Engineering).
11.Explanatory note on fees payable to the European Medicines Agency, 20 March 2014, EMA/800328/2013, Executive Director, European Medicines Agency, London, UK.
8. Communication from the Commission to the European
Parliament, the Council, the European Economic and
Social Committee and the Committee of the Regions :
“Safe, effective and innovative medical devices and in
12.Biomaterials Market – Global Forecasts to 2017, Healthcare Consulting - MarketsandMarkets 2013.
EWMA Journal 2015 vol 15 no 1
Wound Repair and Regeneration
publishes translational research,
evidence-based clinical investigation,
ground-breaking mechanistic studies
focused on wound healing and tissue
regeneration.
Enter the following url
or scan the QR code
to read the articles:
http://bit.ly/
Zi0xkZ
Read the top five accessed articles from
Wound Repair and Regeneration in 2014
PERSPECTIVE ARTICLE: Growth factors and
cytokines in wound healing
Stephan Barrientos, et al.
A randomized controlled trial of larval therapy
for the debridement of leg ulcers: Results of
a multicenter, randomized, controlled, open,
observer blind, parallel group study
Elizabeth Mudge, et al.
Guidelines for the prevention of pressure ulcers
Joyce K. Stechmiller, et al.
Guidelines for the treatment of pressure ulcers
Joanne Whitney, et al.
Interactions between extracellular matrix and
growth factors in wound healing
Gregory S. Schultz, et al.
14-28804
www.wileyonlinelibrary.com/wrr
Smith & Nephew is proud to support healthcare professionals
in your daily efforts to improve the lives of patients, helping you
to deliver better outcomes for patients and healthcare systems.
www.smith-nephew.com
© Smith & Nephew February 2015
56546
We look forward to seeing you at the EWMA congress 2015! Come and visit us at
booth stand 5-30 at the London Excel. Join us at our symposium on the 14th May, 11.15 – 12.15.
Supporting healthcare professionals for over 150 years
Scientific Communication
adrid · Spain
EWMA n GNEAUPP 2014
Submitted to the EWMA
Journal, based on a presentation given at a free paper
session (Free paper session:
Pressure Ulcers) at the
EWMA · GNEAUPP 2014,
Madrid.
Rosie Cameron
MBA, BA, Tissue Viability
Project Lead, NHS GGC
An eLearning modular
approach to pressure
ulcer prevention and
management: the views
of nursing staff
INTRODUCTION
Pressure ulcers are a significant burden both financially and in terms of health-related quality of life.
In response to a growing regard for pressure ulcers
as preventable causes of harm, the Scottish government has been involved in the ongoing development of comprehensive quality-improvement
programmes encompassing standardised pressure
ulcer-prevention packages and the adoption by
some health boards of a “Zero Tolerance” mantra
regarding avoidable pressure damage (NHS HIS
20111.
There is recognition that a key intervention
in the successful achievement of this aim is staff
education; however, traditional methods of delivery in pre and post registration nursing are not
always adequate2-4. Although there is a shortage of
literature exploring the application of eLearning in
the healthcare setting, proposed benefits include:
convenience, flexibility, compatibility with different learning styles, and cost effectiveness, particularly in the delivery of education programmes
on a mass level 4,5
HYPOTHESIS/AIM
This paper considers the views of nursing staff
on the proposed effectiveness of an eLearning
education package for pressure ulcer prevention
and management interventions in NHS Greater
Glasgow and Clyde (NHSGGC).
METHODS
In NHSGGC, a modular eLearning education
package for pressure ulcer prevention and man
Angela Rodgers
BSc Specialist Nursing
Paediatric, RGN, Dip HEN
Child Branch, Tissue
Viability Nurse, NHS GGC
agement was developed by members of the Tissue Viability Team to support staff involved in
patient-care delivery and to ensure education on
a level that supports the achievement of targeted
quality-improvement outcomes. The programme
was based upon existing NHSGGC education
frameworks and incorporated into LearnPro
NHS, a web-based system that records module
completion and assessment, and meets the requirements for both mandatory and role-specific
training. A small group of nursing staff was randomly selected from across various clinical areas
and skill levels, to test the pilot modules prior to
implementation. A qualitative questionnaire was
used to obtain a formal evaluation of experience
upon module completion. The final module content was adapted and implemented according to
relevant feedback from the pilot evaluation.
RESULTS
The uptake for pilot module completion across
NHSGGC was 100% of the pilot group, and
informal feedback from clinical staff was largely
positive. The majority of staff expressed a favourable attitude towards eLearning as a concept, although a small number reported feeling uncertain
about their skills in utilising it fully. The reported
barriers to utilising eLearning mainly included
barriers associated with resources including: time,
computer availability, and lack of IT support. The
majority of participants believed the pressure ulcer
content of the modules to be relevant and sufficient; however, a small number reported finding
the subject matter too basic in relation to their
clinical role and level of individual knowledge.
Lynn Welsh
MA, BSc (Hon), RGN, Adult
Community Vascular Specialist Nurse, NHS GGC
Katrina McGown
Adult Acute Tissue Viability
Nurse, NHS GGC
On behalf of NHS GGC
Tissue Viability Service.
NHSGGC Tissue Viability
Department Centre for Brain
Injuries
70 Commercial Rd
Gorbals, Glasgow
Scotland G5 0QZ
Correspondence:
Lynn.welsh@
ggc.scot.nhs.uk
Conflicts of interest: None

EWMA Journal 2015 vol 15 no 1
61
CONCLUSION
The Tissue Viability Team found eLearning to be
a useful supplement to traditional delivery methods of pressure ulcer prevention and management;
however, a marked challenge was the delivery of
theoretical content that was suitable for clinical staff
with varied knowledge and skill sets across a large
organisation. Future recommendations for practice
include auditing the incidence of pressure damage
in NHSGGC to critically analyse the direct impact
of eLearning education upon patient outcomes.
ACKNOWLEDGEMENTS
Robert McIlreavy and Learn Pro Development
Team
REFERENCES
1. Ashton J, Price P. Survey comparing Clinicians’ wound healing knowledge
and practice. Br J Nurs 2006;15(9):18-26.
2. Gerkin KL, Taylor TH, Weatherby FM. The perception of learning and
satisfaction of nurses in the online environment. J Nurses Staff Dev
2009;25(1):E8-13.
UPCOMING EWMA
INITIATIVES
Antimicrobial Stewardship in Wound Care Programme
The overall aim of the stewardship programme is to
reduce inappropriate and overuse of antimicrobials in
wound care by promoting, facilitating, and teaching
good antimicrobial use practices. The programme builds
on three key objectives and program deliverables:
n Development of treatment recommendations
n A practical guide for implementation of
antimicrobial stewardship
n Execution of educational events
3. Mazzoleni MC, Maugeri C, Rongoni C, Cantoni A, Imbriani M, Maugeri S. Is
it worth investing in online continuous education for healthcare staff? Stud
Health Technol Inform 2012;180: 939-43.
4. NHS Health Improvement Scotland (2011) Preventing Pressure Ulcers
Driver Diagram and Change Package. http://www.healthcareimprovementscotland.org/ programmes/patient_safety/tissue_viability.aspx {accessed3/12/13}.
5. Stephen-Hayes J. Pre-registration nurses’ views on the delivery of tissue
viability. Br J Nurs 2013;22(20):18-23.
Document: Health-Related Quality of Life – the
Patient’s Perspective
The EWMA Council has recently decided to initiate a
project to highlight the importance of evaluating the
patient´s HRQoL in relation to wound management.
The primary objective of this project is to develop recommendations for use of the available HRQoL assessment
tools for wound care patients.
Document: Oxygen Therapies Guidance
The EWMA Oxygen Therapies Guidance Document will
provide practice-oriented guidance on the current use of
various forms of oxygen therapies for wound treatment.
This will include an overview of the available treatment
options, and an assessment of the best available evidence for use.
Finally, the document will explore the main reasons behind the large differences in the use of oxygen therapies
for wound healing between the U.S.A. and Europe, and
the potential for increasing the use of oxygen therapies
in Europe.
Read more about upcoming EWMA initiatives at
www.ewma.org.
Debridement:
Whose problem is it?
Solutions for patients, purchasers and providers
Chairman: Andrew Kingsley, Devon (UK)
Gregory Schultz,
Gainesville (USA)
“The role of biofilms in wound
chronicity”
Andrew Kingsley,
Devon (UK)
“The relationship between the
patient, purchaser and provider
to meet the challenges of debridement”
Trudy Young,
Cardiff (UK)
“Debridement across all age
groups and wound needs using
all available resources”
www.Lohmann-Rauscher.com
Symposium
14 May 2015,
1:15 – 2:15 p.m.
Room Platinum 1 – 2
Scientific Communication
adrid · Spain
EWMA n GNEAUPP 2014
Submitted to the EWMA
Journal, based on a presentation given at a free paper
session (Free paper session:
Pressure Ulcers) at the
EWMA · GNEAUPP 2014,
Madrid.
Major and minor
amputation rates:
What do they tell us?
INTRODUCTION
Any amputation is a major violation of physical
integrity and should be prevented. Other than
amputation due to trauma, the lower limb is
threatened mainly by peripheral arterial disease
and neurovascular foot syndrome. Representatives
from government health departments and patient
organisations across all European countries met
with diabetes experts under the aegis of the World
Health Organization (WHO) Regional Offices
for Europe and the International Diabetes Federation (IDF) in St Vincent, Italy on 10–12 October
1989, and declared a 50% reduction in the rates
of limb amputations due to diabetic gangrene as
one of the five-year targets1.
There has been an ongoing discussion about
whether this target could be achieved, but in recent years some promising data has been published. This manuscript provides a short overview
of these recent studies and highlights the differences between the minor and major amputation
rates.
PATIENTS AND METHODS
To review the literature, we searched PubMed
for the words “lower limb amputation”, “major
amputation”, “minor amputation”, and “diabetes”. Manuscripts were included in our review if
they were published within the last 5 years and
reported population-based trends in major amputation rates over a period of years. The reports are
summarized in Table 1.
RESULTS
Most studies on major amputation report a decrease in the amputation rate. The United States,
United Kingdom, Italy, Finland, Sweden, and
Germany had similar trends of different sizes. A
direct comparison of the figures is difficult and
needs to consider the populations included in each
analysis. For example, higher amputation rates are
reported from the United States Medicare population compared with populations in other countries. The Medicare population includes individuals who are 65 years and older, disabled, or treated
by hemodialysis. Thus, within this population the
absolute number of amputations is high. Other
studies report amputation rates based on the total
population or patients with diabetes only. Thus,
younger age groups are included in the countries
that report lower amputation rates.
In contrast to these countries, studies from
Ireland and Spain did not report a decrease in
the major amputation rates. Major amputation
rates appear to be fixed at a certain level in these
countries.
Minor amputation rates are not reported in all
included studies, and trends are not consistent
with the major amputation rates within a country. Although major amputation rates decreased
in the United Kingdom, Finland, Sweden, and
Germany, minor amputation rates increased. In
Knut Kröger
Vice President of the
Initiative of Chronic
Wounds, Germany
Department of Angiology,
HELIOS Klinikum Krefeld,
Germany
Correspondence:
knut.kroeger@
helios-kliniken.de
Conflicts of interest: None

EWMA Journal 2015 vol 15 no 1
65
Spain and Ireland, minor amputation rates increased when
major amputations rates increased. Only the United Kingdom and Italy had decreasing minor amputation rates.
DISCUSSION
Overall, strategies to reduce major amputation rates in
patients suffering from diabetes mellitus seemed to be successful in many countries. Moxey et al. previously reviewed
the literature for the incidence of lower extremity amputations from 1989 until 2010, and reported significant
reductions in the incidence of lower-extremity amputation
in specific at-risk populations2. Thus, it is surprising to see
that the incidence failed to decrease in some countries in
recent years. Doctors and politicians in these countries are
well advised to analyse the reasons for this lack of decrease.
In light of the rising prevalence of diabetes mellitus, minor
and major amputation rates might represent different aspects of the same problem. Minor amputation rates might
mirror the burden of the rising prevalence of diabetes mellitus and the effects of sufficient or insufficient primary
prophylaxis of foot lesions in a specific population. Major
amputation rates might provide insight into the effectiveness of treatment strategies when a lesion threatens the
limb.
Decreasing major amputations rates indicate that an
increasing number of patients with a threatened limb are
able to obtain optimal treatment to prevent the deterioration of the lesion. Major amputation is conducted only
when all prior efforts have failed. Thus, if a foot lesion can
be treated effectively with antibiotics, then offloading and
revascularisation major amputations will not be necessary.
However, these therapeutic instruments need to reach the
affected patient early enough. Thus, a decrease in major
amputation rates can be achieved effectively and easily
by referring patients to specialised centres early enough.
Such centres have been established in recent years because
these centres can earn money from all the procedures that
are offered.
Foot lesions in people suffering from diabetes mellitus
usually develop outside a medical setting initially, and it
is the patient that has to initiate the first step to contact a
specialist. When the patient finally contacts the specialist,
part of the toes or forefoot may already be destroyed beyond repair and no medical procedure can restore it. Thus,
despite all the available medical procedures, an indication
for minor amputation is given at the time the foot lesion is
seen for the first time by a specialist. A decrease in minor
amputation rates cannot be achieved through specialised
centres, because no procedure exists to restore a toe. Minor amputation rates can be reduced only by improving primary prevention. Primary prevention includes the
dissemination of information to the affected population,
adequate foot wear and foot care, regular foot inspection
to identify early lesions and subsequent offloading, optimal
glycemic control and weight reduction, and so on. Therefore, the primary prevention of foot lesions is expensive.
It cannot be managed by single specialised centres, but
needs to involve all general practitioners and all health
services to reach the total population. The patient or the
health system has to spend money, and no doctor can earn
money offering one specific procedure.
Given these fundamental differences in the reasons
for major and minor amputation, the global target in the
fight against amputations associated with diabetes mellitus should focus on the reduction in minor amputations.
Although each major amputation that is prevented is a
blessing for the patient, major amputation rates only tell
us about the advances in medicine associated with some
specialists. The reduction in minor amputation rates requires a general change in care for patients suffering from
diabetes mellitus to prevent initial lesions.
The reported minor amputation rates can be assumed
to underestimate the true rate, as only minor amputations
involving surgical procedures are counted in the published
literature. A spontaneous demarcation of the distal part
of a small toe can result in a dry gangrene that might
be removed during a routine dressing change. Thus, an
unknown but probably high number of patients suffering
from foot lesions end up with minor amputations that do
not appear in the analysed databases. Therefore, although
some authors have reported decreasing minor amputation
rates in their countries, these results may not represent
the true rate.
REFERENCES
1. Diabetes Care and Research in Europe: The St Vincent
Declaration. World Health Organization, 1989
2. Moxey PW, Gogalniceanu P, Hinchliffe RJ, Loftus IM,
Jones KJ, Thompson MM et al. Lower extremity
amputations--a review of global variability in incidence.
Diabet Med 2011;28:1144-53.
3. Rowe VL, Lee W, Weaver FA, Etzioni D. Patterns of
treatment for peripheral arterial disease in the United
States: 1996-2005. JVS 2009;49: 910-7.
66
4. Goodney PP, Beck AW, Nagle J, Welch HG, Zwolak
RM. National trends in lower extremity bypass surgery,
endovascular interventions, and major amputations.
JVS 2009;50:54-60.
5. Vamos EP, Bottle A, Edmonds ME, Valabhji J, Majeed
A, Millett C. Changes in the incidence of lower
extremity amputations in individuals with and without
diabetes in England between 2004 and 2008. Diabetes
Care 2010;33:2592-7
6. Buckley CM, Kearney PM, Ali F, Bhuachalla CN, Casey
C, Roberts G et al. Concordance studies between
hospital discharge data and medical records for the
recording of lower extremity amputation and diabetes
in the Republic of Ireland. BMC Res Notes 2013;6:148.
7. Almaraz MC, González-Romero S, Bravo M, Caballero
FF, Palomo MJ, Vallejo R et al. Incidence of lower limb
amputations in individuals with and without diabetes
mellitus in Andalusia (Spain) from 1998 to 2006.
Diabetes Res Clin Pract 2012;95:399-405.
EWMA Journal 2015 vol 15 no 1
Scientific Communication
Country,
Study
UNITED STATES
Rowe et al.,
20093
Goodney et al.,
20094
Patients
Period
Major Amputation
Rates
Nationwide inpatient
sample
(age ≥ 18 years)
Medicare population
(age ≥ 65, disabled, or
on hemodialysis)
1996 2005
30.8% to 21.8% of all
acute admissions for
PAD*
263 to 188 per
100,000 insured
UNITED KINGDOM
National hospital activity
Vamos et al.,
data
20105
(age > 16 years)
1996 2006
Minor Amputation
Rates
n.r.
n.r.
2004 2008
118 to 102 per
100,000 people with
diabetes
157 to 149 per 100,000
people with diabetes
Hospital In-patient
enquiry
(age ≥ 16 years)
2005 2009
47.9 to 48.0 per
100,000 people with
diabetes
96.2 to 127 per
100,000 people with
diabetes
Andalusian Health
Service
(age ≥ 30 years)
Lopez-de-Andres et National hospital
discharge data
al., 20118
1998 2006
2001 2008
14.9 to 14.9 per
100,000 people with
diabetes ≥ 30 years
7.12 to 7.47 per
100,000 inhabitants
in patients with type 2
diabetes
13.1 to 14.3 per
100,000 people with
diabetes ≥ 30 years
9.23 to 10.97 per
100,000 inhabitants in
patients with type 2
diabetes
ITALY
Lombardo et al.,
20149
National Hospital
Discharge Record
database
2001 2010
114.5 to 79.3 per
100,000 people with
diabetes
168.8 to 161.1 per
100,000 people with
diabetes
Nationwide registers on
hospital discharges and
causes of death
19972007
13.6 to 9.3 per
100,000 person-years
in patients with
diabetes
11.0 to 13.5 per
100,000 person-years in
patients with diabetes
SWEDEN
Larsson et al.,
200811
Several sources of
information
1982 2001
16 to 6.8 per 100,000
inhabitants with
diabetes
4.7 to 6.5 per 100,000
inhabitants with diabetes
GERMANY
Kröger et al.,
201412
National hospital
discharge data
2005 2011
23.3 to 17.7 per
100,000 inhabitants
35.0 to 41.8 per
100,000 inhabitants
IRELAND
Buckley et al.,
20126
SPAIN
Almaraz et al.,
20127
FINLAND
Winell et al.,
201310
* Peripheral arterial disease
8. López-de-Andrés A, Martínez-Huedo MA, CarrascoGarrido P, Hernández-Barrera V, Gil-de-Miguel A,
Jiménez-García R. Trends in lower-extremity amputations in people with and without diabetes in Spain,
2001-2008. Diabetes Care 2011;34:1570-6
9. Lombardo FL, Maggini M, De Bellis A, Seghieri G,
Anichini R. Lower extremity amputations in persons
with and without diabetes in Italy: 2001-2010. PLoS
One. 2014;9:e86405.
EWMA Journal 2015 vol 15 no 1
10.Winell K, Venermo M, Ikonen T, Sund R. Indicators for
comparing the incidence of diabetic amputations: a
nationwide population-based register study. Eur J Vasc
Endovasc Surg 2013;46:569-74.
11.Larsson J, Eneroth M, Apelqvist J, Stenström A.
Sustained reduction in major amputations in diabetic
patients: 628 amputations in 461 patients in a defined
population over a 20-year period. Acta Orthop
2008;79:665-73.
12.Kröger K, Moysidis T, Feghaly M, Schäfer E, Bufe A;
on behalf of the Initiative Chronische Wunden e.V.,
Germany. Association of diabetic foot care and
amputation rates in Germany. Int Wound J 2014;4.
1
67
SPECIAL EWMA
MEMBERS OFFER
The journal is internationally renowned for its
cutting edge and state-of-the-art research
and clinical articles, as well as its coverage of
management, education and novel therapies.
journal of wound care
C
Journal of Wound Care (JWC) is the leading
source of tissue viability research and
information. JWC is essential reading for all
specialists who wish to enhance their practice
and stay ahead of developments
in wound management and tissue viability.
WC
volume 24. number 1. january 2015
? ?
?? ?
The monthly international Journal of Wound
Care
JWC has an Impact Factor and is Medline,
Scopus, CINAHL and the Thomson Reuters’
Science Citation Index-Expanded and Current
Contents/Clinical Medicine. All aspects of
wound care practice and research are presented
in a well-illustrated, clear and easy to read format
to aid your professional development.
“The Journal of Wound Care is an
extremely valuable resource that contains
a wealth of peer-reviewed papers detailing
the latest advances in wound care research.
A must read for clinicians, academics and
researchers who want to advance their
own knowledge/practice and keep abreast
of the wound care literature.”
Measurement of microelectric potentials
in a bioelectrically-active wound care device
Evaluation of bactericidal effect of antiseptics on bacteria isolated from wounds
Clinical evaluation of a next-generation antimicrobial dressing
Effect of a tackifying agent on the properties of ceramide 2 hydrocolloid dressings
Use of HBOT and a living bilayer skin substitute on a compromised skin flap
JoWC_2014_24_1_0_cover.indd 1
22/12/2014 11:23
Caroline McIntosh, Head of Podiatry,
National University of Ireland
SAVE 10% – SUBSCRIBE TODAY
Obtain access to the online archive containing all content
published in JWC since 1999 with an online subscription†.
EWMA members quote EWMA14 to receive your discount*
†Online archive accessible only via a online only OR print and online subscription. *Promotional code required
Visit:
www.magsubscriptions.com/jwc
or call us on: +44 (0) 1722 716 997
Join us for debate and discussion:
Journal of Wound Care
Submit your next paper to
Organ der Deutschen Gesellschaft für Phlebologie
Organ der Schweizerischen Gesellschaft für Phlebologie,
Bulletin de la Société Suisse de Phlébologie
Organ der Arbeitsgemeinschaft Dermatologische Angiologie der Deutschen Dermatologischen Gesellschaft
Organ des Berufsverbandes der Phlebologen e.V.
Als Forum für die europäische phlebologische Wissenschaft
widmet sich die CME-zertifizierte Zeitschrift allen relevanten
phlebologischen Themen in Forschung und Praxis: Neue
diagnostische Verfahren, präventivmedizinische Fragen sowie
therapeutische Maßnahmen werden in Original- und Übersichtsarbeiten diskutiert.
Die offiziellen Mitteilungen und Leitlinien der Deutschen
Gesellschaft für Phlebologie werden regelmäßig publiziert,
verschiedene Foren bieten Gelegenheit zum Erfahrungsaustausch zwischen Klinik und Praxis.
2015. 44. Jahrgang | 6 Hefte jährlich | ISSN 0939-978X
[email protected]
www.phlebologieonline.de
7th Joint Meeting of
the European Tissue Repair Society (ETRS)
& the Wound Healing Society (WHS)
ETRS
From Bed to Bench
With the theme “From Bed to Bench” the Copenhagen 2015
ETRS/WHS joint meeting aims to create a forum to facilitate
the translation from the clinical to the experimental side of
wound healing. Please submit your abstract and register for
the meeting at www.etrs-whs2015.org
21-23 October 2015
Copenhagen, Denmark
www.etrs-whs2015.org
Scientific Communication
adrid · Spain
EWMA n GNEAUPP 2014
Submitted to the EWMA
Journal, based on a presentation given at
The European Society for
Clinical Nutrition
and Metabolism (ESPEN)
Guest Session: Obesity and
wound management:
The role of nutrition at the
EWMA - GNEAUPP 2014,
Madrid
Wound risk and
prevention in obesity:
The role of nutrition
INTRODUCTION
Obesity is a worldwide problem, not only because of its serious medical
comorbidities but also due to its increasing prevalence. It has recently been
estimated that the prevalence of obesity has nearly doubled since 1980; 35%
and 11% of adults older than 20 years of age are now overweight or obese,
respectively, and 65% of the world’s population live in nations in which
people who are overweight or obese are more likely to die than people who
are underweight1. Therefore, a growing number of obese people will need
medical assistance. The purpose of this short review is to address the nutritional aspects of wound risk and prevention in obese people.
WOUND RISK FACTORS IN OBESE PEOPLE
Obese people often have several wound risk factors, as shown in Table 1.
Some of these may be preventable, but others are not. In addition, obesity
may impair the body’s normal reaction to the effects of gravity. Pressure causes
the brain to order a positional change to relieve ischemia, but positional
changes may be challenging for obese people and their caregivers, leading
to increased susceptibility to pressure sores2.
María D. Ballesteros-Pomar
MD, PhD
Endocrinology and Nutrition
Department, Clinical Nutrition Unit.
Complejo Asistencial
Universitario de León
Altos de Nava s/n 24008
León, Spain.
Correspondence:
mdballesteros@telefonica.
net
Conflicts of interest: None
SKIN DISORDERS IN OBESE PEOPLE
Obesity and associated comorbidities increase the likelihood of impaired
skin integrity and slow-to-heal wounds. Therefore, obese people are at risk
of developing pressure ulcers, perigenital irritant dermatitis due to urinary
and/or fecal incontinence, benign (e.g., candidal intertrigo, erythrasma) or
more serious (e.g., cellulitis, necrotizing fasciitis) skin infections, venous
ulcers, diabetic foot ulcerations, and surgical site infections3.
Obese people face numerous challenges in maintaining their skin integrity4 due to many pathogenic factors5, as shown in Figure 1. Obese people
are at risk of delayed wound healing due to reduced oxygen and nutrient
perfusion as a result of cardiovascular changes. Furthermore, adipose tissue
has a relatively reduced blood supply, leading to inadequate oxygenation.
Hypoventilation is also common in obese individuals, which reduces tissue
oxygenation4.
Furthermore, moisture and microorganism collection in the skin folds
of obese individuals can also increase the risk of infection and decrease skin
integrity. Immobility, friction, and shear due to substantial weight stress
the skin’s barrier function. Nutritional aspects also have a central role in the
pathogenesis of skin disorders in obese people. In particular, obese people

EWMA Journal 2015 vol 15 no 1
71
TABLE 1.
WOUND RISK FACTORS IN OBESE PEOPLE.
• Advanced age
• Cognitive impairment/altered sensory
perception
• Hypoxia, infection/sepsis
• Intensive care unit experience,
especially vent-dependency
• Hyperglycemia/diabetes
• Inadequate perfusion/oxygenation/
circulation
• Reduced mobility and difficult positional
changes
• Multiple trauma/burns
• Pre-operative illnesses/co-morbidities
(e.g., cardiovascular disease)
Figure 1. Pathogenic mechanisms
of wound risk in obese people
(adapted from Pierpoint et al.5).
may be malnourished despite their physical appearance.
This issue will be addressed in the present overview, as
malnutrition can lead to inadequate protein, vitamins,
and nutrients that are essential to wound repair4.
THE ROLE OF VASCULARITY AS A WOUND RISK
FACTOR IN OBESE PEOPLE
Some recent reviews and studies have addressed the role of
vascularity as a wound risk factor in obese people5-7. An
inherent decreased vascularity of adipose tissue has been
described in obese people, and increased adiposity induces
a signalling cascade that positively feeds back to impair
angiogenesis and cause chronic low-grade inflammation.
In addition, increased expression of 11β-hydroxysteroid
dehydrogenase type 1 (11βHSD1), an intracellular glucocorticoid-amplifying enzyme, has been observed in obese
people. As glucocorticoids suppress angiogenesis, the elevated level of 11βHSD1 serves to amplify the inhibitory effects of glucocorticoids. As adipose tissue becomes
hypoxic from impaired angiogenesis, hypoxia-inducible
factor 1 alpha (HIF1β) levels increase and initiate local
inflammation and fibrosis, which further impair the angiogenic process and wound healing. Other microvascular
abnormalities linked to obesity include reduced nitrogen
oxide availability, which impairs microvascular rarefaction,
and prolonged elevation of free fatty acids in the blood due
to increased fat mass, which impairs capillary recruitment5.
In surgical wounds, the increased tension on wound
edges that frequently occurs in obese people contributes
72
• Some disease states that cause hyper metabolism and increase nutritional risk
to wound dehiscence8. Wound tension increases tissue
pressure, reducing microperfusion and the availability of
oxygen to the wound. The increase in pressure ulcers or
pressure-related injuries in obese individuals is also influenced by hypovascularity, as poor perfusion makes tissue
more susceptible to this type of injury. Venous insufficiency is another vascular factor associated with the development of chronic wounds and delayed wound healing5.
OTHER PATHOGENIC MECHANISMS OF WOUND
RISK IN OBESE PEOPLE
Beyond impaired angiogenesis and vascularity, chronic
low-grade inflammation associated with obesity is another
important pathogenic mechanism of skin disorders and
impaired wound healing. Obesity-related microangiopathy and alterations in immune mediators may lengthen
the inflammatory stage of wound healing and leave obese
individuals more susceptible to infections.
Oxidative stress has also been linked to obesity, especially abdominal obesity, through a deficiency in adiponectin, an adipocytokine that protects against oxidative
stress and inflammation. Low adiponectin levels impair
wound healing via two mechanisms: impaired angiogenesis
and impaired keratinocyte proliferation and migration,
which is a critical process in the re-epithelialisation phase
of wound healing4,5. Another aspect of wound healing that
is potentially affected by a hypoxic environment in obesity is the capability of fibroblasts to synthesise collagen5.
EWMA Journal 2015 vol 15 no 1
Scientific Communication
DIABETES AND WOUND HEALING
IN OBESE PEOPLE
Obesity is often associated with metabolic complications,
with diabetes being one of the most relevant complications
that also has an important role in wound risk and impaired
healing. Poor blood glucose control impairs wound healing
and increases risk of infection, and the metabolic stress
caused by the wound further increases blood glucose.
In diabetic patients, foot ulcers and pressure-related
chronic non-healing wounds are always accompanied by
hypoxia9, resulting from insufficient perfusion and angiogenesis8. Hypoxia may further increase the early inflammatory response, which prolongs injury by increasing levels of oxygen radicals. Hyperglycemia also increases
the production of oxygen radicals, thereby contributing
to oxidative stress. The formation of advanced glycation
end products under hyperglycemic conditions is associated
with impaired wound healing. High levels of metalloproteases found in diabetic foot ulcers and chronic wounds are
also associated with tissue destruction and inhibit normal
repair processes. Diabetic patients exhibit dysregulated
cellular functions leading to inadequate bacterial clearance
and delayed or impaired repair, such as defects in T-cell
immunity, leukocyte chemotaxis, phagocytosis, bactericidal capacity, and dysfunctional fibroblasts and epidermal
cells10. Diabetic neuropathy also contributes to impaired
wound healing. Figure 2 shows factors that contribute to
impaired healing in individuals with diabetes.
MALNUTRITION AND WOUND HEALING
As previously mentioned, obesity does not necessarily imply a good nutritional status. Obese people are sometimes
malnourished because of bad nutritional habits or fad diets, but malnutrition is difficult to detect. This paradoxical
malnutrition results from a calorie-dense diet that is high
in carbohydrates and fats and low in vitamins and minerals5. Many micronutrient and macronutrient deficiencies
have been described in obese people11. Among 232 obese
individuals studied by Ernst et al12. before bariatric surgery, 12.5% were deficient for albumin, 8.0% for phosphate, 4.7% for magnesium, 6.9% for ferritin, 6.9% for
hemoglobin, 24.6% for zinc, 3.4% for folate, 18.1% for
vitamin B12, 32.6% for selenium, 5.6% for vitamin B3,
2.2% for vitamin B6, 2.2% for vitamin E, and 25.4% for
25-OH vitamin D. Albumin deficiency and anemia were
positively correlated with body mass index (BMI), and
48.7% of the obese people included in the study showed at
least one nutritional deficiency. As proper wound healing
requires adequate levels of vitamins and minerals5, obese
people may be at risk of impaired wound repair.
Therefore, obese people may have depleted lean body
mass and protein stores while maintaining high levels of
adipose mass and may be deficient in many vitamins and
minerals needed for healing. Furthermore, detecting malnutrition is not easy in these individuals, as many nutrition
screening tools rely on BMI or percentage weight loss,
making it difficult to assess malnutrition. 
Figure 2. Potential effects of diabetes
on wound healing. MMPs, matrix metalloproteases; ROS, reactive oxygen
species; AGEs, advanced glycation
end products (adapted from Guo et
al.8.
EWMA Journal 2015 vol 15 no 1
73
PREVENTION OF WOUNDS IN OBESE PEOPLE
Some preventative measures might decrease the risk of skin
breakdown and maximise wound healing in obese people13. It is very important to maintain skin integrity using
cleansers, lotions, moisture barrier ointments, and sealants.
Also, patient independence and mobility should be promoted through the use of supplies, equipment, adaptive
devices, and rooms designed for obese patients. Special
attention should be paid to tube site care, positioning,
and stabilisation. Leg elevation and external compression
to encourage fluid recirculation is also important to avoid
pressure sores. Furthermore, an adequate staff-to-patient
ratio significantly helps to prevent sores13.
ROLE OF NUTRITION IN PREVENTING
PRESSURE SORES
Evidence-based guidelines on pressure ulcer prevention
and treatment that have been developed by the European
Pressure Ulcer Advisory Panel (EPUAP)14 and the American National Pressure Ulcer Advisory Panel (NPUAP)15
specifically address the role of nutrition in preventing pressure sores. First, general recommendations are made for
the screening and assessment of nutritional status of every
individual at risk for pressure ulcers, as the early identification and management of undernutrition can prevent
pressure ulcer development. The guidelines suggest using
any valid, reliable, and practical tool for nutritional screening that is quick and easy to use and acceptable to both
the individual and health care worker as well as having
a nutritional screening policy in place in all health care
settings. The Braden Risk Assessment Scale for predicting
pressure ulcer risk includes a nutrition subscale that can be
used in the nutrition screening and assessment process16.
The problem for obese people is that any tool based on
body weight may underestimate malnutrition, and there is
currently no screening tool validated for obese individuals.
Second, the guidelines propose providing nutritional
support to each individual with nutritional and pressure
ulcer risks by performing nutritional assessment, estimating nutritional requirements, comparing nutrient intake
with estimated requirements, providing appropriate nutrition intervention based on an appropriate feeding route,
and monitoring and evaluating nutritional outcome. Individuals with nutritional and pressure ulcer risks should
receive at least 30-35 kcal per kg body weight per day,
with 1.25-1.5 g/kg/day protein and 1 ml/kcal/day fluid
intake. Obese individuals should not be underfed when
at wound risk. When estimating their energy needs, the
use of adjusted body weight or specific formulae should
be considered. In obese people, beware of calories, but
maintain or increase protein supply.
Third, a specific recommendation is to offer highprotein mixed oral nutritional supplements and/or tube
feeding in addition to the usual diet to individuals with
nutritional and pressure ulcer risks. This recommendation
is based on a systematic review and meta-analysis showing
a 25% reduction in pressure ulcer development in at-risk
patients with high-protein oral nutritional supplements
(250-500 kcal/day) compared to routine care17. Obese
people should not be excluded from this recommendation
when they are either malnourished or at high nutritional
risk. A decision tree on nutrition in pressure ulcers prevention and treatment has been published by EPUAP14.
In conclusion, obesity itself should be recognised as a relevant risk factor for wounds, even more so if complicated
by diabetes or cardiovascular disease. Also, as obese people
may be malnourished, nutritional assessment and management, as in any other at-risk patient, is vital for wound
prevention.
REFERENCES
World Health Organization. Obesity and Overweight.
Fact sheet N°311. Reviewed May 2014. Available
at:http://www.who.int/mediacentre/factsheets/fs311/en/
Accessed July 20,2014.
pathy, hypertension, and insulin resistance. Circulation.
2004;109(21):2529-35. Epub 2004 May 10.
Levy BI, Schiffrin EL, Mourad JJ, Agostini D, Vicaut E,
Safar ME, Struijker-Boudier HA. Impaired tissue
perfusion: a pathology common to hypertension,
obesity, and diabetes mellitus. Circulation.
2008;118(9):968-76.
Lowe JR. Skin integrity in critically ill obese patients. Crit
Care Nurs Clin North Am 2009;21(3):311-22.
Beitz JM. Providing quality skin and wound care for the
bariatric patient: an overview of clinical challenges.
Ostomy Wound Manag. 2014;60(1):12-21.
Trans Tasman Dietetic Wound Care Group - Professional Association. Evidence based practice guidelines
for the nutritional management of adults with pressure
injuries. 2011. NGC:008729. Available at: http://daa.
asn.au/wp-content/uploads/2011/09/Trans-TasmanDietetic-Wound-Care-Group-Pressure-Injury-Guidelines-2011.pdf . Accesssed July 21, 2014.
Guo S, Dipietro LA. Factors affecting wound healing. J
Dent Res. 2010;89(3):219-29. Epub 2010 Feb 5.
Tandara AA, Mustoe TA. Oxygen in wound healing—
more than a nutrient. World J Surg 2004; 28:294-300.
Sibbald RG, Woo KY. The biology of chronic foot ulcers
in persons with diabetes. Diabetes Metab Res Rev
2008;24(Suppl 1):25-30.
Moizé V, Deulofeu R, Torres F, de Osaba JM, Vidal J.
Nutritional intake and prevalence of nutritional
deficiencies prior to surgery in a Spanish morbidly
obese population. Obes Surg. 2011;21(9):1382-8.
Pierpont YN, Dinh TP, Salas RE, Johnson EL, Wright
TG, Robson MC, Payne WG. Obesity and surgical
wound healing: a current review. ISRN Obes. 2014 Feb
20;2014:638936.
de Jongh RT, Serné EH, IJzerman RG, de Vries G,
Stehouwer CD. Impaired microvascular function in
obesity: implications for obesity-associated microangio
74
Ernst B, Thurnheer M, Schmid SM, Schultes B.
Evidence for the necessity to systematically assess
micronutrient status prior to bariatric surgery. Obes
Surg. 2009;19(1):66-73. Epub 2008 May 20.
Mathison CJ.Skin and wound care challenges in the
hospitalized morbidly obese patient. J Wound Ostomy
Continence Nurs. 2003;30(2):78-83.
Clark M, Schols JM, Benati G, Jackson P, Engfer M,
Langer G, Kerry B, Colin D; European Pressure Ulcer
Advisory Panel. Pressure ulcers and nutrition: a new
European guideline. J Wound Care. 2004;13(7):26772.
Dorner B, Posthauer ME, Thomas D and National
Pressure Ulcer Advisory Panel. The Role of Nutrition in
Pressure Ulcer Prevention and Treatment: National
Pressure Ulcer Advisory Panel White Paper. 2009
NPUAP Nutrition White Paper. Available at: http://
www.npuap.org/wp-content/uploads/2012/03/NutritionWhite-Paper-Website-Version.pdf. Accessed July 24,
2014.
Braden B. The Braden Scale for Pressure Ulcer
Prediction. Available at: http://www.bradenscale.com/
images/bradenscale.pdf. Accesed July 25, 2014.
Stratton RJ, Ek AC, Engfer M, Moore Z, Rigby P, Wolfe
R, Elia M. Enteral nutritional support in prevention and
treatment of pressure ulcers: a systematic review and
meta-analysis. Ageing Res Rev. 2005;4(3):422-50.
EWMA Journal 2015 vol 15 no 1
More Healing
+
Less Pain
=
(That’s all the math I need to know)
Ferris Mfg. Corp. 5133 Northeast Parkway, Fort Worth, TX 76106 USA • +1 817-900-1301 • www.polymem.eu
Unless otherwise indicated, all trademarks are owned by or licensed to Ferris. © 2013, Ferris Mfg. Corp., Fort Worth, TX 76106 USA
MKL-680 REV-0 0315
EPUAP 2015
18th Annual Meeting of the European
Pressure Ulcer Advisory Panel
16 – 18 September 2015
Ghent · Belgium
www.epuap2015.org
Venue: Culture and Conference Centre Het Pand
PUTTING THE PRESSURE
IN THE HEART OF EUROPE
• Early registration deadline 15 June 2015
• Abstract submission deadline 30 April 2015
Organised by the European Pressure Ulcer Advisory Panel
and the University Centre for Nursing & Midwifery (Ghent University)
in cooperation with
EPUAP Business Office
[email protected]
+420 251 019 379
Cochrane Reviews
ABSTRACTS OF RECENT
­COCHRANE REVIEWS
Publication in The Cochrane Library Issue 7, 2014
Phototherapy for treating
pressure ulcers
Chiehfeng Chen, Wen-Hsuan Hou, Edwin SY Chan,
Mei-Ling Yeh, Heng-Lien Daniel Lo.
Citation: Chen C, Hou WH, Chan ESY, Yeh ML, Lo
HLD. Phototherapy for treating pressure ulcers.
Cochrane Database of Systematic Reviews 2014,
Issue 7. Art. No.: CD009224. DOI:
10.1002/14651858.CD009224.pub2.
Copyright © 2014 The Cochrane Collaboration.
Published by John Wiley & Sons, Ltd.
ABSTRACT
Background: A pressure ulcer is defined as “an area of
localized injury to the skin and/or underlying tissue,
usually over a bony prominence, as a result of pressure, or pressure in combination with shear”. The use
of phototherapy - that is, light (or laser) used as an
adjuvant, non-surgical intervention, with the aim of
having a therapeutic effect on healing - has increased
recently.
Objectives: To determine the effects of phototherapy
on the healing of pressure ulcers.
Search methods: In January 2014, we searched the
Cochrane Wounds Group Specialised Register; The
Cochrane Central Register of Controlled Trials (CENTRAL); Ovid MEDLINE; Ovid EMBASE; Ovid MEDLINE
(In-Process & Other Non-Indexed Citations); and
EBSCO CINAHL. We did not restrict the search by language or publication date.
Selection criteria: Randomised controlled trials (RCTs)
comparing the effects of phototherapy (in addition to
standard treatment) with sham phototherapy (in addition to standard treatment), another type of phototherapy (in addition to standard treatment) or standard or
conventional treatment alone.
Data collection and analysis: Two review authors
assessed studies for relevance and design according to
EWMA Journal 2015 vol 15 no 1
the selection criteria, extracted data and evaluated
study quality. The authors made attempts to obtain
missing data by contacting study authors. Disagreement was resolved by consensus and discussion with a
third review author.
Main results: We identified seven RCTs involving 403
participants. All the trials were at unclear risk of bias.
Trials compared the use of phototherapy with standard
care only (six trials) or sham phototherapy (one trial).
Only one of the trials included a third arm in which
another type of phototherapy was applied. Overall,
there was insufficient evidence to determine the relative
effects of phototherapy for healing pressure ulcers.
Time to complete healing was reported in three studies. Two studies showed the ultraviolet (UV) treated
group had a shorter mean time to complete healing
than the control group (mean difference -2.13 weeks
(95% CI -3.53 to -0.72, P value 0.003)). One study
reported that the laser group had a longer mean time
to complete healing than the control group (mean difference 5.77 weeks; 95% CI -0.25 to 11.79). However,
this result should be interpreted with caution, as these
were small studies and the findings may have been due
to chance. Three studies reported proportions of ulcers
healed with a variety of results. One study reported a
different outcome measure, and the other two studies
had different treatment durations. These variations did
not allow us to pool the studies and draw any conclusions as to whether phototherapy is effective or not.
Adverse effects were reported in only two studies that
compared phototherapy with control; the risk ratio for
adverse events was imprecise. One study reported risk
ratio (RR) 0.72 (95%CI 0.18 to 2.80). However,
another study reported RR 0.89 (95% CI: 0.71 to 1.12)
based on the number of events in each group, rather
than the number of people with events. Among five
studies reporting the rate of change in ulcer area, three
studies found no statistically significant difference
between the two groups. Pooling was not undertaken
because of differences in outcome measures reported.
The results were based on data from trials with unclear
risk of bias for which generation of the randomisation
sequence, concealment allocation and blinding of outcome assessors were unclear. No studies reported on
quality of life, length of hospital stay, pain or cost.
Authors’ conclusions: We are very uncertain as to the
Sally Bell-Syer, MSc
Managing Editor
Cochrane Wounds Group
Department of
Health Sciences
University of York
United Kingdom
Correspondence:
[email protected]
Conflicts of interest: None
www.wounds.cochrane.org

77
effects of phototherapy in treating pressure ulcers. The quality of
evidence is very low due to the unclear risk of bias and small
number of trials available for analysis. The possibility of benefit
or harm of this treatment cannot be ruled out. Further research
is recommended.
Plain language summary
Phototherapy for treating pressure ulcers
What are pressure ulcers? Pressure ulcers (also called bed sores
or pressure sores) are sores on the skin caused by constant pressure or friction. They usually affect people who are immobilised
or find it difficult to move themselves, for example the elderly or
paralysed. Pressure ulcers frequently occur on bony parts of the
body, such as the heels and hips, and also on the coccyx (tail
bone). Pressure ulcers do not always heal, and, if they do heal,
healing can take a long time.
What is phototherapy? Phototherapy is a treatment in which
part of the body is exposed to daylight, a or light of a specific
wavelength. It is used for treating a variety of diseases, and may
involve lights and lasers. Phototherapy is used to treat pressure
ulcers in the hope that it will reduce the time the ulcers take to
heal.
The purpose of this review: This review tried to find out whether
phototherapy treatment(s) given in addition to standard care
(i.e. pressure relief, removal of dead tissue from the wound,
infection control and application of dressings) improves healing
times for pressure ulcers. Standard care plus phototherapy could
be compared against standard care alone, or against standard
care plus sham phototherapy, or against standard care plus
another type of phototherapy.
Findings of this review: The review authors searched the medical literature up to 7 January 2014, and identified seven relevant
medical trials, with a total of 403 participants. Six trials compared the use of phototherapy with standard care only; one trial
compared it with standard care plus sham phototherapy. Only
one trial included a third treatment group that investigated
another type of phototherapy.
Two trials reported the time taken for pressure ulcers to heal
completely, and these showed an improvement in healing time
for people in the phototherapy group who received treatment
with ultraviolet light. However, this result should be interpreted
with caution, as these were small, poor quality trials, at unclear
risk of bias (i.e. with potentially misleading results), and the findings may have been due to chance. The other trials reported
either conflicting results or various measures/time points among
trials, which meant that we could not conclude whether or not
phototherapy is effective for treating pressure ulcers. Two trials
reported incidence of harmful (adverse) effects and noted no
significant differences between the phototherapy and standard
treatment groups. Four trials provided funding information, two
from industry funding, the others from an institutional grant. No
studies reported on quality of life, length of hospital stay, pain or
cost.
This review identified only a few, small studies provided with
insufficient evidence to support the use of phototherapy as a
routine treatment for pressure ulcers. More trials will need to be
78
conducted before it can be established whether this treatment
works and is safe.
Perioperative corticosteroids for preventing
complications following facial plastic surgery
Edina MK da Silva, Bernardo Hochman, Lydia M Ferreira.
Citation: da Silva EMK, Hochman B, Ferreira LM. Perioperative
corticosteroids for preventing complications following facial plastic surgery. Cochrane Database of Systematic Reviews 2014,
Issue 6. Art. No.: CD009697. DOI: 10.1002/14651858.
CD009697.pub2.
Copyright © 2014 The Cochrane Collaboration. Published by
John Wiley & Sons, Ltd.
ABSTRACT
Background: Early recovery is an important factor for people
undergoing facial plastic surgery. However, the normal inflammatory processes that are a consequence of surgery commonly
cause oedema (swelling) and ecchymosis (bruising), which are
undesirable complications. Severe oedema and ecchymosis
delay full recovery, and may make patients dissatisfied with procedures.Perioperative corticosteroids have been used in facial
plastic surgery with the aim of preventing oedema and ecchymosis.
Objectives: To determine the effects, including safety, of perioperative administration of corticosteroids for preventing complications following facial plastic surgery in adults.
Search methods: In January 2014, we searched the following
electronic databases: the Cochrane Wounds Group Specialised
Register; the Cochrane Central Register of Controlled Trials
(CENTRAL) (The Cochrane Library); Ovid MEDLINE; Ovid
MEDLINE (In-Process & Other Non-Indexed Citations); Ovid
Embase; EBSCO CINAHL; and Literatura Latino-Americana e
do Caribe em Ciências da Saúde (LILACS). There were no
restrictions on the basis of date or language of publication.
Selection criteria: We included RCTs that compared the administration of perioperative systemic corticosteroids with another
intervention, no intervention or placebo in facial plastic surgery.
Data collection and analysis:
Two review authors independently screened the trials for inclusion in the review, appraised trial quality and extracted data.
Main results: We included 10 trials, with a total of 422 participants, that addressed two of the outcomes of interest to this
review: swelling (oedema) and bruising (ecchymosis). Nine studies on rhinoplasty used a variety of different types, and doses, of
corticosteroids. Overall, the results of the included studies
showed that there is some evidence that perioperative administration of corticosteroids decreases formation of oedema over
the first two postoperative days. Meta-analysis was only possible
for two studies, with a total of 60 participants, and showed that
a single perioperative dose of 10 mg dexamethasone decreased
EWMA Journal 2015 vol 15 no 1
Cochrane Reviews
oedema formation in the first two days after surgery (SMD =
-1.16, 95% CI: -1.71 to -0.61, low quality evidence). The evidence for ecchymosis was less consistent across the studies, with
some contradictory results, but overall there was some evidence
that perioperatively administered corticosteroids decreased
ecchymosis formation over the first two days after surgery (SMD
= -1.06, 95% CI:-1.47 to -0.65, two studies, 60 participants,
low quality evidence ). The difference was not maintained after
this initial period. One study, with 40 participants, showed that
high doses of methylprednisolone (over 250 mg) decreased both
ecchymosis and oedema between the first and seventh postoperative days. The only study that assessed facelift surgery identified no positive effect on oedema with preoperative administration of corticosteroids. Five trials did not report on harmful
(adverse) effects; four trials reported that there were no adverse
effects; and one trial reported adverse effects in two participants
treated with corticosteroids as well as in four participants treated
with placebo. None of the studies reported recovery time, patient
satisfaction or quality of life. The studies included were all at an
unclear risk of selection bias and at low risk of bias for other
domains.
Authors’ conclusions: There is limited evidence for rhinoplasty
that a single perioperative dose of corticosteroids decreases
oedema and ecchymosis formation over the first two postoperative days, but the difference is not maintained after this period.
There is also limited evidence that high doses of corticosteroids
decrease both ecchymosis and oedema between the first and
seventh postoperative days. The clinical significance of this
decrease is unknown and there is little evidence available
regarding the safety of this intervention. More studies are
needed because at present the available evidence does not support the use of corticosteroids for prevention of complications
following facial plastic surgery.
Plain language summary
Corticosteroids for preventing complications following facial
plastic surgery
Complications following facial plastic surgery: Today, facial
plastic surgery is one of the most common types of surgery. People frequently chose to have it for aesthetic (beauty) reasons, so
doctors need to minimise the unpleasant effects (complications)
associated with these procedures. All surgical procedures produce an inflammatory response, which may cause swelling and
bruising. Severe swelling and bruising are troublesome for
patients, as they delay full recovery.
Why corticosteroids might help: Corticosteroids, more often
known as ‘steroids’, are medicines that doctors prescribe to
reduce inflammation in a wide range of conditions. They are
commonly used in facial plastic surgery to reduce swelling and
bruising, though it is not known how efficient or safe they might
be.
The purpose of this review: This review tried to find out whether
giving corticosteroids around the time of facial plastic surgery
reduces swelling and bruising compared to another intervention,
no intervention, or a fake medicine (placebo).
Findings of this review: The review authors searched the medi-
EWMA Journal 2015 vol 15 no 1
cal literature up to January 2014, and identified 10 relevant
medical trials, with a total of 422 participants. Nine of these
studies were on people having rhinoplasty (surgery to reshape
the nose) and one was on people having a facelift.The trials
investigated a variety of corticosteroid medicines, as well as different doses of corticosteroids. People in the studies were
assessed for swelling and bruising for up to 10 days after surgery. None of the studies stated the funding source.
There was some low quality evidence that a single dose of corticosteroid administered prior to surgery might reduce swelling
and bruising over the first two days after surgery, but this advantage was not maintained beyond two days. One study, with 40
participants, showed that high doses of corticosteroid decreased
both swelling and bruising between the first and seventh postoperative days. The usefulness of these results is uncertain and
there is currently no evidence regarding the safety of the treatment. Five trials did not report on harmful (adverse) effects; four
trials reported that there were no adverse effects; and one trial
reported adverse effects in two participants treated with corticosteroids as well as in four participants treated with placebo. None
of the studies reported recovery time, patient satisfaction or
quality of life.
Therefore, the current evidence does not support use of corticosteroids as a routine treatment in facial plastic surgery. More trials will need to be conducted before it can be established
whether this treatment works and is safe.
Chinese herbal medicines for treating skin and
soft-tissue infections
Yun Fei Wang, Hua Fa Que, Yong-Jun Wang, Xue Jun Cui.
Citation: Wang YF, Que HF, Wang Y-J, Cui XJ. Chinese herbal
medicines for treating skin and soft-tissue infections. Cochrane
Database of Systematic Reviews 2014 , Issue 7 . Art. No.:
CD010619. DOI: 10.1002/14651858.CD010619.pub2 .
Copyright © 2014 The Cochrane Collaboration. Published by
John Wiley & Sons, Ltd.
ABSTRACT
Background: Skin and soft-tissue infections (SSTIs) are common
infections of the epidermis, dermis or subcutaneous tissue. SSTIs
range in severity from minor, self-limiting, superficial infections
to deep, aggressive, gangrenous, life-threatening infections.
Some classifications divide SSTIs into ‘complicated’ and
‘uncomplicated’ infections based on clinical severity. Treatments
of SSTIs involves antibiotic therapy, surgical debridement or
drainage, and resuscitation if required. Sometimes these treatments are limited by high treatment costs, bacterial resistance to
antibiotics and side effects, therefore, many people with SSTIs
are turning to Chinese herbal medicines to treat this problem.
Chinese herbal medicines are natural substances that have been
used for centuries in China where they are generally considered
to be effective for SSTIs. Some Chinese herbal medicines have
been shown to have antibacterial and anti-inflammatory properties, although a few herbal medicines have been reported to 
79
have side effects. Therefore there is a need to review the current
clinical evidence systematically to inform current practice and
guide future studies on Chinese herbal medicines for SSTIs.
Objectives: To evaluate the benefits and harms of Chinese
herbal medicines for treating skin and soft-tissue infections
(SSTIs).
Search methods: Searches were not restricted by date, language
or publication status. In July 2014 we searched the following
electronic databases: the Cochrane Wounds Group Specialised
Register; the Cochrane Central Register of Controlled Trials
(CENTRAL) (The Cochrane Library); Ovid MEDLINE; Ovid
MEDLINE (In-Process & Other Non-Indexed Citations); Ovid
EMBASE; Ovid AMED (Allied and Complementary Medicine);
and EBSCO CINAHL.
Selection criteria: All randomised controlled trials (RCTs) in
people with SSTIs that compared Chinese herbal medicines with
another intervention or control.
Data collection and analysis: Two review authors screened the
literature search results independently; there were no disagreements.
Main results: We identified no RCTs that met the inclusion criteria.
Authors’ conclusions: There is currently no information available from RCTs to support or refute the use of Chinese herbal
medicines in treating people with SSTIs.
Plain language summary
Should Chinese herbal medicines be used in patients with skin
and soft-tissue infections?
What are skin and soft-tissue infections? Skin and soft-tissue
infections (SSTIs) are common infections of the skin or the tissue
beneath the skin. They include impetigo, abscesses, cellulitis,
erysipelas, necrotising (flesh-killing) skin infections, infections
caused by animal or human bites or by animal contact, and
infections after surgery.
Most SSTIs do not require treatment, but heal by themselves.
Some SSTIs are more serious and can become life-threatening,
and these need medical treatment.
What are Chinese herbal medicines? Chinese herbal medicines
are mostly extracts of plants, or parts of plants, that are used
individually, or combined, as medicines. These traditional medicines have been used in China for centuries, and Chinese doctors currently prescribe them to treat SSTIs.
Why use Chinese herbal medicines for SSTIs? In the Western
world antibiotics are used to treat SSTIs, however antibiotics are
expensive, can cause harms (side effects) as well as benefits, are
not suitable for all people, and are becoming less effective as
bacteria start to develop resistance to them. Alternative treatments need to be identified, and Chinese herbal medicines
could provide that alternative.
80
The purpose of this review: The aim of this review was to see if
medical research showed whether Chinese herbal medicines are
an effective treatment for SSTIs. We wanted to compare the use
of Chinese herbal medicines with other treatments, or a fake
treatment (placebo), to see which produced a better outcome
for patients in a particular type of medical study called a ‘randomised controlled trial’.
Findings of this review: We could not find any randomised controlled trials that compared the use of Chinese herbal medicines
for treating SSTIs with other treatments or a placebo. Therefore,
we cannot support or refute the use of Chinese herbal medicines
to treat SSTIs.
In future, we hope that randomised controlled trials will be conducted to evaluate the benefits and side effects of Chinese
herbal medicines compared with current practice for the treatment of SSTIs. These trials would help people and doctors to
decide on the best way to treatment SSTIs.
Publication in The Cochrane Library Issue 8, 2014
Dressings for the prevention of surgical
site infection
Jo C Dumville, Trish A Gray, Catherine J Walter, Catherine A
Sharp, Tamara Page.
Dumville JC, Walter CJ, Sharp CA, Page T. Dressings for the prevention of surgical site infection. Cochrane Database of Systematic Reviews 2011, Issue 7. Art. No.: CD003091. DOI:
10.1002/14651858.CD003091.pub2.
Copyright © 2014 The Cochrane Collaboration. Published by
John Wiley & Sons, Ltd.
ABSTRACT
Background: Surgical wounds (incisions) heal by primary intention when the wound edges are brought together and secured often with sutures, staples, clips or glue. Wound dressings, usually applied after wound closure, provide physical support, protection from bacterial contamination and absorb exudate. Surgical site infection (SSI) is a common complication of surgical
wounds that may delay healing.
Objectives: To assess the effects of wound dressings for preventing SSI in people with surgical wounds healing by primary intention.
Search methods: In February 2014 we searched: The Cochrane
Wounds Group Specialised Register; The Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library);
The Database of Abstracts of Reviews of Effects (DARE) (The
Cochrane Library); The Health Technology Assessment Database (HTA) (The Cochrane Library); NHS Economic Evaluation
Database (NHSEED) (The Cochrane Library); Ovid MEDLINE;
Ovid MEDLINE (In-Process & Other Non-Indexed Citations);
EWMA Journal 2015 vol 15 no 1
Cochrane Reviews
Ovid EMBASE and EBSCO CINAHL. There were no restrictions
based on language or date of publication or study setting.
Selection criteria: Randomised controlled trials (RCTs) comparing alternative wound dressings or wound dressing with no dressing (wound exposure) for the postoperative management of surgical wounds healing by primary intention.
Data collection and analysis: Two review authors performed
study selection, risk of bias assessment and data extraction independently..
Main results: Twenty RCTs were included (3623 participants).
All trials were at unclear or high risk of bias. Twelve trials
included people with wounds resulting from surgical procedures
with a contamination classification of ‘clean’, two trials included
people with wounds resulting from surgical procedures with a
‘clean/contaminated’ contamination classification and the
remaining trials evaluated people with wounds resulting from
various surgical procedures with different contamination classifications. Two trials compared wound dressings with leaving
wounds exposed. The remaining 18 trials compared two alternative dressing types. No evidence was identified to suggest that
any dressing significantly reduced the risk of developing an SSI
compared with leaving wounds exposed or compared with alternative dressings in people who had surgical wounds healing by
primary intention.
Authors’ conclusions: At present, there is insufficient evidence
as to whether covering surgical wounds healing by primary
intention with wound dressings reduces the risk of SSI or whether
any particular wound dressing is more effective than others in
reducing the rates of SSI, improving scarring, pain control,
patient acceptability or ease of dressing removal. Most trials in
this review were small and at high or unclear risk of bias. However, based on the current evidence, we conclude that decisions
on wound dressing should be based on dressing costs and the
symptom management properties offered by each dressing type
e.g. exudate management.
Plain language summary: No recommendations regarding type
of wound dressing for the prevention of surgical site infection
Millions of surgical procedures are conducted globally each
year. The majority of procedures result in wounds in which the
edges are brought together to heal using stitches, staples, clips
or glue - this is called ‘healing by primary intention’. Afterwards,
wounds are often covered with a dressing that acts as a barrier
between them and the outside environment. One advantage of
this may be to protect the wound from micro-organisms, and
thus infection. Many different dressing types are available for
use on surgical wounds, however, it is not clear whether one
type of dressing is better than any other at preventing surgical
site infection, or, indeed, whether it is better not to use a dressing at all. We conducted a review of all available, relevant, evidence regarding the impact of dressings on the prevention of
surgical site infections in surgical wounds healing by primary
intention. The review examined data from 16 randomised controlled trials and found no evidence to suggest either that one
dressing type was better than any other, or that covering these
wounds with dressings at all was better at preventing surgical
EWMA Journal 2015 vol 15 no 1
site infection, or that any dressing type improves scarring, pain
control, patient acceptability or ease of removal. It is important
to note that many trials in this review were small and of poor
quality, at high or unclear risk of bias and there is an overall lack
of evidence. Decisions on wound dressing should be based on
dressing costs and the need for management of specific symptoms e.g., absorption of exudate.
Publication in The Cochrane Library Issue 11, 2014
Wound drainage following groin dissection for
malignant disease in adults
David R Thomson, Hazim Sadideen, Dominic Furniss.
Citation example: Thomson DR, Sadideen H, Furniss D. Wound
drainage following groin dissection for malignant disease in
adults. Cochrane Database of Systematic Reviews 2014 , Issue
11 . Art. No.: CD010933. DOI: 10.1002/14651858.CD010933.
pub2 .
Copyright © 2014 The Cochrane Collaboration. Published by
John Wiley & Sons, Ltd.
ABSTRACT
Background: Groin dissection is commonly performed for the
treatment of a variety of cancers, including melanoma, and
squamous cell carcinoma of the skin, penis or vulva. It is uncertain whether insertion of a drain reduces complication rates,
and, if used, the optimum time for drain removal after surgery is
also unknown.
Objectives: To assess the current level of evidence to determine
whether placement of a drain is beneficial after groin dissection
in terms of reducing seroma, haematoma, wound dehiscence
and wound infection rates, and to determine the optimal type
and duration of drainage following groin dissection if it is shown
to be beneficial.
Search methods: In September 2014 we searched the following
electronic databases using a pre-designed search strategy: the
Cochrane Wounds Group Specialised Register; The Cochrane
Central Register of Controlled Trials (CENTRAL) (The Cochrane
Library). In November 2013 we searched Ovid MEDLINE; Ovid
MEDLINE (In-Process & Other Non-Indexed Citations); Ovid
EMBASE and EBSCO CINAHL. We did not restrict the search
and study selection with respect to language, date of publication
or study setting.
Selection criteria: We considered all randomised controlled trials (RCTs) comparing wound drainage with no wound drainage
in individuals undergoing groin dissection, where the most superior node excised was Cloquet’s node (the most superior inguinal
lymph node). No limits were applied to language of publication
or trial location. Two review authors independently determined
the eligibility of each trial.

81
Data collection and analysis: Two review authors, working independently, screened studies identified from the search; there
were no disagreements.
Tissue adhesives for closure of surgical incisions
Main results: We did not identify any RCTs that met the inclusion criteria for the review.
Jo C Dumville, Paul Coulthard, Helen V Worthington, Philip
Riley, Mathew Fortnam, Neil Patel, James Darcey, Marco
Esposito, Maarten van der Elst, Oscar J F van Waes
Authors’ conclusions: There is a need for high quality RCTs to
guide clinical practice in this under-researched area.
Plain language summary: The effects of using drainage tubes
after surgical removal of lymph glands from the groin
What are lymph glands? Lymph glands are part of the body’s
immune system and swell or enlarge when the body is fighting
an infection. They are located in a number of places in the body,
including the neck, armpits, and groin.
Why remove lymph glands? Surgical removal of the lymph
glands found in the groin (the inguinal lymph nodes) is an
important part of the treatment for several types of cancer,
including melanoma and other types of skin cancer, as well as
squamous cell cancer of the penis, vulva and the surrounding
skin. Sometimes complications, such as wound infection, bruising (haematoma) or a collection of lymph fluid in the area
(seroma), can occur after removal of these lymph nodes.
Why insert drainage tubes after surgery? Surgeons can insert
plastic drainage tubes into the area from which the lymph nodes
have been removed. These tubes are inserted towards the end of
the operation, once the lymph glands have been removed. The
aim of the drainage tubes is to drain away any fluid or blood
that may collect in the wounds and cause complications. The
drains are usually left in place until the amount of fluid draining
out of them in a 24-hour period has reduced to a certain volume
(typically less than 30 mL to 100 mL), although some surgeons
will remove the drains at a particular time point after surgery
(this can vary from 1 day to more than 1 week). Patients can
remain in hospital while the drain is in place, although many
surgeons will let patients leave hospital and have the drain managed on an outpatient basis.
However, it is unclear whether placement of a drainage tube
reduces, increases or has no effect on complications following
this type of surgery. Furthermore the best timing for removal of
drainage tubes is unknown.
The purpose of this review: The aim of this review was to review
all randomised clinical trials (RCTs) that have compared what
happens to patients who had a drain inserted after removal of
the inguinal lymph nodes with patients who did not have a drain.
We also looked for RCTs that examined the effect of removing
drains at different times. We searched the medical literature up
to September 2014 to gather all the available evidence.
What the review discovered: We did not identify any RCTs that
compared what happens when you do or do not use drains after
surgery for inguinal lymph node removal and therefore we still
do not know if drains are beneficial in this context.
82
Citation example: Dumville JC, Coulthard P, Worthington HV,
Riley P, Fortnam M, Patel N, Darcey J, Esposito M, van der Elst
M, van Waes OJ F. Tissue adhesives for closure of surgical incisions. Cochrane Database of Systematic Reviews 2014 , Issue
11 . Art. No.: CD004287. DOI: 10.1002/14651858.CD004287.
pub4
Copyright © 2014 The Cochrane Collaboration. Published by
John Wiley & Sons, Ltd.
ABSTRACT
Background: Sutures (stitches), staples and adhesive tapes have
been used for many years as methods of wound closure, but tissue adhesives have entered clinical practice more recently. Closure of wounds with sutures enables the closure to be meticulous, but the sutures may show tissue reactivity and can require
removal. Tissue adhesives offer the advantages of an absence of
risk of needlestick injury and no requirement to remove sutures
later. Initially, tissue adhesives were used primarily in emergency
room settings, but this review looks at the use of tissue adhesives
in the operating room/theatre where surgeons are using them
increasingly for the closure of surgical skin incisions.
Objectives: To determine the effects of various tissue adhesives
compared with conventional skin closure techniques for the closure of surgical wounds.
Search methods: In March 2014 for this second update we
searched the Cochrane Wounds Group Specialised Register; The
Cochrane Central Register of Controlled Trials (CENTRAL) (The
Cochrane Library); Ovid MEDLINE; Ovid MEDLINE (In-Process
& Other Non-Indexed Citations); Ovid EMBASE and EBSCO
CINAHL. We did not restrict the search and study selection with
respect to language, date of publication or study setting.
Selection criteria: Only randomised controlled trials were eligible for inclusion.
Data collection and analysis: We conducted screening of eligible studies, data extraction and risk of bias assessment independently and in duplicate. We expressed results as randomeffects models using mean difference for continuous outcomes
and risk ratios (RR) with 95% confidence intervals (CI) for dichotomous outcomes. We investigated heterogeneity, including both
clinical and methodological factors.
Main results: This second update of the review identified 19
additional eligible trials resulting in a total of 33 studies (2793
participants) that met the inclusion criteria. There was low quality evidence that sutures were significantly better than tissue
adhesives for reducing the risk of wound breakdown (dehiscence; RR 3.35; 95% CI 1.53 to 7.33; 10 trials, 736 participants
EWMA Journal 2015 vol 15 no 1
that contributed data to the meta-analysis). The number needed
to treat for an additional harmful outcome was calculated as 43.
For all other outcomes - infection, patient and operator satisfaction and cost - there was no evidence of a difference for either
sutures or tissue adhesives. No evidence of differences was
found between tissue adhesives and tapes for minimising dehiscence, infection, patients’ assessment of cosmetic appearance,
patient satisfaction or surgeon satisfaction. However there was
evidence in favour of using tape for surgeons’ assessment of
cosmetic appearance (mean difference (VAS 0 to 100) 9.56
(95% CI 4.74 to 14.37; 2 trials, 139 participants). One trial
compared tissue adhesives with a variety of methods of wound
closure and found both patients and clinicians were significantly
more satisfied with the alternative closure methods than the
adhesives. There appeared to be little difference in outcome for
different types of tissue adhesives. One study that compared
high viscosity with low viscosity adhesives found that high viscosity adhesives were less time-consuming to use than low viscosity
tissue adhesives, but the time difference was small.
This is how life feels
to people with EB.
Their skin is as fragile as a butterfly’s
wing. They have Epidermolysis Bullosa,
a painful and currently incurable skin
blistering condition.
www.debra-international.org
Authors’ conclusions: Sutures are significantly better than tissue
adhesives for minimising dehiscence. In some cases tissue adhesives may be quicker to apply than sutures. Although surgeons
may consider the use of tissue adhesives as an alternative to
other methods of surgical site closure in the operating theatre,
they need to be aware that sutures minimise dehiscence. There
is a need for more well designed randomised controlled trials
comparing tissue adhesives with alternative methods of closure.
These trials should include people whose health may interfere
with wound healing and surgical sites of high tension.
Plain language summary: Tissue adhesives for closure of surgical skin incisions. Tissue adhesives or glues are increasingly used
in place of stitches (sutures) or staples to close wounds. It has
been suggested that tissue adhesives may be quicker and easier
to use than sutures for closing surgical wounds. Tissue adhesives
carry no risk of sharps injury - unlike needles that are used for
sutures - and are thought to provide a barrier to infection. This
may mean that they also promote healing, and the need for
removal of sutures is avoided.
The researchers searched the medical literature up to March
2014, and identified 33 medical studies that investigated the
use of tissue adhesives for closure of wounds. They compared
tissue adhesive with another method of closure such as sutures,
staples, tape, or another type of tissue adhesive. The main outcomes of interest were whether wounds stayed closed - and did
not break down - and whether they became infected. The results
of the review showed clearly that fewer wounds broke down
when sutures were used. Studies also reported that some types
of tissue adhesives might be slightly quicker to use than other
types. There was no clear difference between tissue adhesives
and the alternative closure methods for cosmetic results or costs.
Results regarding surgeons’ and patients’ preferred skin closure
method were mixed.
International.
0+´
iopå¨
læø’
m,.-
IOPÅ^
LÆØ*
M;:_
EWMA Journal
Previous Issues
Volume 14
Number 2
October 2014
Published by
European
Wound Management
Association
WOUND CARE
– SHAPING THE FUTURE
Rf
dC
A PATIENT,
PROFESSIONAL,
PROVIDER
AND PAYER
PERSPECTIVE
Volume 14, no 2, October 2014
Economic outcomes of a new chronic wound treatment system
in Poland
Grzegorz Krasowski, Robert Wajda, Małgorzata Olejniczak-Nowakowska
Dressings for split thickness skin graft donor sites
Dorte P. Barrit, Hanne Birke-Sorensen
The utility of pulse volume waveforms in the identification of
lower limb arterial insufficiency
Jane H Davies, Jane E A Lewis, E Mark Williams
The importance of using a nutritional risk analysis scale in
patients admitted to continued care
Jose M Corrales, Nuria P Gayo, Mª del Carmen P Águila,
Almudena M Martín, Ana Ribeiro
Neonatal facial pressure ulcers related to non-invasive ventilation
Laura Bonell-Pons, Pablo García-Molina, Evelin Balaguer-López,
Mª Ángeles Montal, María C Rodríguez
Volume 14, no 1, May 2014
Prevalence of pressure ulcers in hospitalized patients in
Germany
Heidi Heinhold, Andreas Westerfellhaus, Knut Kröger
Excess use of antibiotics in patients with non-healing ulcers
Marcus Gürgen
Regenerative medicine in burn wound healing: Aiming for the
perfect skin
Magda MW Ulrich
Promising effects of arginine-enriched oral nutritional supplements on wound healing
Jos M.G.A. Schols
Efficacy of platelet-rich p
­ lasma for the treatment of chronic
wounds
Vladimir N. Obolenskiy, Darya A. Ermolova, Leonid A. Laberko,
Tatiana V. Semenova.
Volume 13, no 2, October 2013
Risk assessment scales for ­pressure ulcers in intensive care
units: A systematic review with meta-analysis
F. P. García-Fernández et al.
Pressure-time integral of elastic versus inelastic bandages
H. Partsch, G. Mosti
VERUM – A European approach for successful venous leg ulcer
healing
R. Brambilla et al.
Effect of topical h
­ aemoglobin on venous leg ulcer healing
M. Arenbergerova et al.
The effects of an arginine-enriched oral nutritional supplement
on chronic wound healing in non-malnourished patients
J. Schols et al.
Efficacy of honey gel in the treatment of chronic lower leg
ulcers
O. Tellechea et al.
Other journals
EWMA wishes to facilitate the exchange of
information on wound healing in a broad perspective
with this section on International Journals.
ACTA
VULNOLOGICA
ORGANO UFFICIALE DELL’ASSOCIAZIONE ITALIANA ULCERE CUTANEE
Volume 12
December 2014
No. 4
CONTENTS
165
187
Infections and pressure sores
A novel methacrylate powder dressing
(Altrazeal®) for hard-to-heal wounds. Case report
ORIGINAL ARTICLES
CASE REPORTS
Brenta F., Vischio M., Scalise A., Jaber O., Scevola D.,
Nicoletti G.
177
Evaluation of the efficacy of a preparation containing essential fatty acids and plant extracts
in the prevention and treatment of dehydrated
skin in diabetic patients
Federici A., Federici G.
Vol. 12 - No. 4
Fraccalvieri M., Morozzo U., Salomone M., Ruka E.,
Fava R.
193
An infected wound secondary to subcutaneous
heroin injection: self-management in wound
care. Case report
Acquaro J., Sales P., Bignamini E.
ACTA VULNOLOGICA
XV
Save the Date
for
2015!
Clinical Symposium on Advances in Skin & Wound Care • September 18-21, 2015 •
Hyatt Regency, New Orleans, Louisiana
Advances in
SKIN&
WOUND
CARE
®
The International Journal
for Prevention and Healing
www.woundcarejournal.com
C M E
Volume 28 Number 2 February 2015
CLINICAL MANAGEMENT EXTRA
Changes in Classifications of Chronic Lower-Limb Wound Codes in Patients with Diabetes:
ICD-9-CM Versus ICD-10-CM
Jeanne R. Lowe, PhD, RN; Greg Raugi, MD, PhD; Gayle E. Reiber, PhD, MPH; and JoAnne D. Whitney, PhD, RN, CWCN, FAAN
ORIGINAL INVESTIGATIONS
What Is the Healing Time of Stage II Pressure Ulcers? Findings from a Secondary Analysis
Alvisa Palese, MNS; Saiani Luisa, MNS; Pota Ilenia, BNS, RN; Dario Laquintana, MNS; Giuseppe Stinco, MD; Paola Di Giulio, MNS, RN;
and on behalf of the PARI-ETLD Group
Use of Silicone Materials to Simulate Tissue Biomechanics as Related to Deep Tissue Injury
Jessica L. Sparks, PhD; Nicholas A. Vavalle, MS; Krysten E. Kasting; Benjamin Long, MS; Martin L. Tanaka, PhD; Phillip A. Sanger, PhD;
Karen Schnell, MSN; and Teresa A. Conner-Kerr, PhD
Association of Sociodemographic Factors with Hope for Cure, Religiosity, and Spirituality in
Patients with Venous Ulcers
Geraldo Magela Salomé, PhD, RN; Sergio Aguinaldo de Almeida, RN; and Lydia Masako Ferreira, MD, PhD
PLUS
Payment Strategies • Practice Points • Infolink
Endorsed by
Lippincott Williams & Wilkins
Finnish
Infections and pressure sores
Brenta F., Vischio M., Scalise A., Jaber O., Scevola D.,
Nicoletti G.
Evaluation of the efficacy of a preparation con¬taining
essential fatty acids and plant extracts in the prevention
and treatment of dehydrated skin in diabetic patients
Federici A., Federici G.
A novel methacrylate powder dressing (Altrazeal®) for
hard-to-heal wounds. Case report
Fraccalvieri M., Morozzo U., Salomone M., Ruka E., Fava R.
An infected wound secondary to subcutaneous heroin injection: self-management in wound care. Case report
Acquaro J., Sales P., Bignamini E.
Advances in Skin & Wound Care, vol. 28, no 2, 2015
www.aswcjournal.com
English
Use of Silicone Materials to Simulate Tissue Biomechanics
as Related to Deep Tissue Injury
Jessica L. Sparks, PhD; Nicholas A. Vavalle, MS; Krysten E.
Kasting; Benjamin Long, MS; Martin L. Tanaka, PhD; Phillip
A. Sanger, PhD; Karen Schnell, MSN; and Teresa A. ConnerKerr, PhD
What Is the Healing Time of Stage II Pressure Ulcers?
Findings from a Secondary Analysis
Alvisa Palese, MNS; Saiani Luisa, MNS; Pota Ilenia, BNS,
RN; Dario Laquintana, MNS; Giuseppe Stinco, MD;
Paola Di Giulio, MNS, RN; and on behalf of the PARI-ETLD
Group
Association of Sociodemographic Factors with Hope for
Cure, Religiosity, and Spirituality in Patients with
Venous Ulcers
Geraldo Magela Salomé, PhD, RN; Sergio Aguinaldo de
Almeida, RN; and Lydia Masako Ferreira, MD, PhD
Haava, no. 4, 2014
www.shhy.fi
Trip skater’s frost bite
Heli Kavola
The blade of skate is as sharp as knife of chef
Immy Berry, Sara Maastovaara
Some things just do not work
Sirpa Paananen
Occasions
Piia Grek-Stjernberg
Spectrum of wounds in the doctor’s station
Ritva Saraste
Recognition and come across of a patient with traumatic
crisis
Päivi Vuokila-Olkkonen
Matti’s experience of traumatic crisis
Sirpa Tapio
Research from the world
OCD: baceteriofobia and fear of smithereens
Ulla Dunder
Hundreds of wounds, skin lacerations and damages challenge the helpers
Anu Pukki
The care and prevention of malnutrition among the
patients with wounds
Susanna von Knorring , Kaisa Kajander
EPUAP 2014, Stockholm
Volume 13, no 1, April 2013
The Biofilm-forming capacity of s­ taphylococcus aureus
from chronic wounds can be useful for determining Wound-Bed
Preparation methods
Y. Yarets, L. Rubanov, I. Novikova, N. Shevchenko
In vitro efficacy of various topical antimicrobial agents against
multidrug-resistant bacteria
M. Hajská, L. Slobodníková, H. Hupková, J. Koller
The mTOR inhibitors and the skin wound healing
F. Benhadou, V. del Marmol
A review of evidence for negative pressure wound therapy
(NPWT) use post spinal surgery
R. A. Atkinson, K. J. Ousey, S. Lui, J. B. Williamson
A randomized study on the effectiveness of a new pressurerelieving ­mattress overlay for the prevention of pressure ulcers
in elderly patients at risk
E. Ricci, C. Roberto, A. Ippolito, A. Bianco, M. T. Scalise
Motorcycle ride position, venous return, and symptoms of
­chronic venous insufficiency
Ellie Lindsay, P. Vowden, K. Vowden, J. Megson
Acta Vulnologica, vol. 12, no 4, 2015
www.vulnologia.it
Italian
Spanish
Helcos, vol. 25, no. 4, 2014
Pressure ulcers epidemiology in Spain in 2013: results
from the 4th National Prevalence Survey”
Pedro L. Pancorbo-Hidalgo et al.
Variability on the mangment of chronic wounds. What do
nurses think about”
José Antonio Esperón Güimil et al
The EWMA Journals can be downloaded free of charge from www.ewma.org
84
EWMA Journal 2015 vol 15 no 1
EWMA
Int. Journal of Lower Extremity Wounds vol. 13, no 4, 2014
http://ijlew.sagepub.com
English
Fa
ct
or
: 2.
02
3
Current
Total-pages: 124
Spine-width: 4.00mm
Paper-type: UPM Gloss 70
ISSN 1742-4801
20
13
Im
pa
ct
february 2015 | volume 12 | issue 1
inte rna tio na l wo und jo urna l
international wound journal
An international journal for multidisciplinary
wound research and practice
ore granulation
porcine study comparing
Therapy to VeraFlo™ Therapy
aline, there was 43%* more
ranulation after 7 days
of therapy.
february 2015 | volume 12 | issue 1
®
CH
SSING
H FOR
T LAYER
r medical
RESSURE
Editor-in-Chief: Professor Keith Harding
Editor: Dr Douglas Queen
www.systagenix.com
d Granulation Response In Vivo.
MEDLINE Listed
Available online: wileyonlinelibrary.com/journal/iwj
sician and product instructions
tary to KCI Licensing, Inc., LifeCell
1/16/15 1:28 PM
VOLUME 23 ISSUE 4 NOVEMBER 2014
ISSN 0965-206X
base
ye on
search
0 titles | 5,000 Publishers
JOURNALOF
tissueviability
s
ies
dvantage of
nd services.
In this issue:
• Establishing community wound prevalence within an inner London borough
• Honey for non-healing leg ulcers
• Analysis of microcirculation in sore-prone pressure areas on conventional and anti-decubitus
hospital mattresses
Official Journal of the
29-11-2014 01:55:26
English
journal of wound care
C
opus
Difficult Situations Managing Diabetic Foot. Evidences and
Personal Views: Is to Operate on Patients With Diabetic Foot
Osteomyelitis Old-Fashioned?
Eric Senneville and Sophie Nguyen
Confronting a Dramatic Situation: The Charcot Foot Complicated
by Osteomyelitis
Luca Dalla Paola
Do Diabetic Foot Infections With Methicillin-Resistant Staphylococcus aureus Differ From Those With Other Pathogens?
Besa Zenelaj, Cindy Bouvet, Benjamin A. Lipsky, and Ilker Uçkay
Saving the Limb in Diabetic Patients With Ischemic Foot Lesions
Complicated by Acute Infection
Giacomo Clerici and Ezio Faglia
Pain in chronic venous insufficiency
(including venous claudication)
M. Stücker; M. Dörler
Peripheral arterial occlusive disease (PAOD)
The most important differential diagnosis in leg pain
C. Jeanneret-Gris
Chronic critical ischaemia of the legs
T. O. Meier; B. R. Amann-Vesti
Neurogenic claudication
A. Mehrkens; B. Jeanneret
Restless legs syndrome
J. Hafner; P. Dziunycz; A.L. Frauchiger; N. Gräni; F.
Kaufmann; N. Jaberg-Bentele; C. Luder; M.T. Mohanna;
P. Stieger; B. Weber; D.O. Mayer; S. Läuchli; C. Buset
Complex regional pain syndrome
(CRPS) Previously Sudeck’s atrophy
J. Hafner; C. Buset; P. Dziunycz; N. Gräni; F. Kaufmann;
N. Jaberg-Bentele; C. Luder; M.T. Mohanna; P. Stieger; B.
Weber; D.O. Mayer; S. Läuchli; A.L. Frauchiger
Wound pain
N. Gräni; C. Buset; P. Dziunycz; A.L. Frauchiger; F.
Kaufmann; N. Jaberg-Bentele; C. Luder; M.T. Mohanna;
P. Stieger; B. Weber; D.O. Mayer; S. Läuchli; J. Hafner
Journal of Tissue Viability, vol. 23, no 4, 2014
www.journaloftissueviability.com
English
telligence
HDFURVV
Phlebologie, vol. 43, no 6, 2014
www.schattauer.de
German
WC
volume 24. number 1. january 2015
? ?
?? ?
The monthly international Journal of Wound
Care
Measurement of microelectric potentials
in a bioelectrically-active wound care device
Evaluation of bactericidal effect of antiseptics on bacteria isolated from wounds
Clinical evaluation of a next-generation antimicrobial dressing
Effect of a tackifying agent on the properties of ceramide 2 hydrocolloid dressings
Use of HBOT and a living bilayer skin substitute on a compromised skin flap
Establishing community wound prevalence within an inner
London borough: Exploring the complexities
A. Hopkins , F. Worboys
A quantitative analysis of microcirculation in sore-prone pressure
areas on conventional and pressure relief hospital mattresses
using laser Doppler fl owmetry and tissue spectrophotometry
J. Rothenberger , S. Krauss , M. Held , D. Bender , H.-E. Schaller ,
A. Rahmanian-Schwarz , M.A. Constantinescu , P. Jaminet
Letter to the Editor
Honey for non-healing leg ulcers
S.S. Tin , V. Wiwanitkit
English
Rane vol. 4, no 1, 2013
www.lecenjerana.com
Novel AG /alginate nanocomposites for wound treatments:
animal studies
Jasmina Stojkovska, et.al
Clinical forms of plantar necrotising fasciitis
Cedomir S Vucetic, et.al
The significance of D - dimer in early diagnosis of deep vein
­thrombosis in coagulation disorder patients (abstract)
Ivana Jelic
The possibilities of use of dermoscopy as a diagnostic method in
chronic venous insufficiency and chronic venous ulceration (abstract)
Javorka B. Delic, Vesna Mikulic
Swedish
Sårmagasinet vol. 1, no 1, 2014
www.ntvw.nl
Journal of Wound Care, vol. 24, no 1, 2015
www.journalofwoundcare.com
Evaluation of bactericidal effect of three antiseptics on
bacteria isolated from wounds
D.U.A. Kumara, S.S.N. Fernando, J. Kottahachchi, D.M.B.T.
Dissanayake, G.I.D.D.A.D. Athukorala, N.S. Chandrasiri, K.W.N.
Damayanthi, M.H.S.L. Hemarathne, A.A. Pathirana
A real-life clinical evaluation of a next-generation antimicrobial
dressing on acute and chronic woundsl
M. Walker, D. Metcalf, D. Parsons, P. Bowler
Measurement of microelectric potentials in a bioelectricallyactive wound care device
in the presence of bacteria
S.S. Park, H. Kim, I.R.S. Makin, J.B. Skiba, M.J. Izadjoo
Use of HBOT and a living bilayer skin substitute for a compromised flap with chronic steroid use: a case report
A.L. Pistorio, J. Leslie, R.B. Gustavson, R.C. Baynosa
The effect of the concentration of tackifying agent on the
adhesive and skin protective properties of ceramide
2-containing hydrocolloid dressings
M. Kohta, T. Iwasak
SårMAGASINET
E n t i d s k r i f t f r å n s å r s j u k s k ö t e r s k o r i Sv e r i g e
Rapport
från EPUAP
•
NY
tidning
Tema: trycksår
SårMagasinet nr 1 2014
Leczenie Ran vol. 11, no 3, 2014
Polish
Protein metabolism in the patients with thermal injury
Kucharzewski M, Ryszkiel I, Wilemska-Kucharzewska K,
Rojczyk-Gołębiewska E, Pałasz A
The evaluation of chosen extracellular matrix enzymes activity
during regeneration of experimental thermal injuries
Olczyk P, Komosińska-Vassev K, Winsz-Szczotka K, Stojko J,
Klimek K, Gajewski K, Olczyk K
The speed of healing process of the leg venous ulcer after application of the foam dressing with silver ions – own experience
Kucharzewski M, Mieszczańsk P, Wilemska-Kucharzewska K
In vitro evaluation of the single and multispecies biofilm prevention capabilities of two wound irrigation solutions and a topical
antiseptic
Westgate SJ, Cutting KC
Lithuanian
Theme Pressure ulcers
Focus EPUAP, Stockholm
From shame to success, the journey of a geriatric hospital
Sit/and position change clinics
Paediatric pressure ulcers
PUCLAS 3
New Clinical guidelines, pressure ulcers
Pressure ulcers in the spinal cord injured
Pressure ulcers an African initiative
nr 1 2014
1
Wounds (SÅR) vol. 23, no 1, 2015
www.saar.dk
Portrait of the bacteria Pseudoomonas aeruginosa
Henrik Pierre Calum
Wound care – General management and local competences
Jens Fonnesbech
Sitting positions that work! Two experienced occupational therapist swill teach nurses and therapists how to build a common
language and share specialist skills
Jens Fonnesbech
Wound support in Central Region Denmark – support function
for telemedicine wound assessment
Jens Fonnesbech
Status on National Telemedicine Wound project
Dorthe S. Lassen, Merete H. Jensen
“On this principle have I based a practice” Joseph Lister and
the early antiseptics.
Adam Bencard
Scandinavian
Lietuvos chirurgija, vol. 14, no 3, 2014
www.chirurgija.lt
Endoscopic ultrasound predicts early recurrence of esophageal
varices after endoscopic band ligation: a prospective cohort study
Masalaite L, Valantinas J, Stanaitis J
Successful video-assisted thoracic surgery for pleural empyema
Jagelavicius Z, Jovaišas V, Kybartas A, Zilinskas A, et al.
Treatment of local complications that develop after catheterisation
through the femoral artery puncture
Asakiene I, Cernauskas A, Misonis N, Zabulis V, et al.
Good results with transcutaneous tibial nerve stimulation for
advanced chronic constipation treatment
Stundiene I, Zeromskas P, Pfeifer J, Valantinas J
Neurilemoma of intrathoracal vagal nerve: clinical case
Askinis R, Krasauskas A, Zaremba S, Cicenas S
EWMA Journal 2015 vol 15 no 1
Wund Management, vol. 8, no 6, 2014
English abstracts are available from www.mhp-verlag.de
German
ISSN 1864-1121
8. Jahrgang
74528
6
2014
Wund
Management
Schwerpunktthema: Chronische Wunden und Ernährung
Originalarbeit
Effektivität einer azellulären synthetischen
Matrix als Ergänzung zur Standardversorgung
bei Ulcus cruris venosum und mixtum:
Vergleich von klinischen Studiendaten
und Routinedaten
Übersicht
Bedarf und Einfluss der Ernährung
auf die Wundheilung
Pflegelexikon
Exsudat
– Bedeutung und Bewertung
Cochrane Pflegecorner
Frühes versus spätes
postoperatives Baden oder
Duschen zur Verhinderung
von Wundkomplikationen
Dèbridement mit medizinischen Larven
– Ein Update
Blickpunkt
Bedürfnisorientierte und bedarfsgerechte
Ernährung in der stationären Altenhilfe
Images
Livedovaskulopathie
Offizielles Mitteilungsorgan
Initiative Chronische Wunden e. V. (ICW e. V.)
Österreichische Gesellschaft für Wundbehandlung (AWA)
Schweizerische Gesellschaft für Wundbehandlung (SAfW)
Wundnetz Kiel e. V.
Wundverbund Südwest e. V.
Wundzentrum Hamburg e. V.
Wundzentrum Nord e. V.
000_Titel_0614.indd 1
18.11.14 14:09
Effectiveness of an Acellular Synthetic Matrix as an
Adjunct to Standard Care in Venous and Mixed Leg
Ulcers: Comparison of Clinical Study Data and Routine
Data
M. Augustin*, M. Gutknecht, Z. Anastasiadou, K. Heyer,
K. Harding, P. Aldons, H. Edwards, M. Stacey, E.-L. Heinrichs, R. Shannon
Larval debridement therapy – an update (Review)
K. Protz
EWMA 2015
LONDON
EWMA 2015 Conference in London, UK
By José Verdú Soriano, EWMA Scientific Recorder.
·
BY
OC
IAT IO N
W
·
86
NDORS
SE E
ED
UR
N
The 2015 programme will offer guest sessions from several
organisations that are active in thematic issues related to
wound healing and management.
An International Partner Session will be hosted by EWMA’s American Partner, the Association for the Advance-
EHEALTH IN WOUND CARE
-FROM THE PERSPECTIVE OF HEALTH
CARE PROFESSIONALS
E U R OP EA
The conference theme is WOUND CARE – SHAPING
THE FUTURE - A PATIENT, PROFESSIONAL, PROVIDER, AND PAYER PERSPECTIVE, which reflects that
the interdisciplinary teamwork and collaboration between
patients, professionals, and policy makers are essential for
facilitating good practice and providing continuity of care.
This will be even more important in the future, as health
care systems throughout Europe have to cope with increasing pressure to demonstrate the efficient and cost-effective
use of resources to optimise wound care with the help of
innovative procedures and practices. It is imperative that
all these perspectives are considered if we are to realise the
goal of successful wound management.
Stay informed by visiting the conference
website, www.
ewma2015.org, to see
registration opportunities or obtain further
information about the
programme. You can
also get your updates
on EWMA’s social
media platforms.
The full-day streams are extremely
popular among EWMA conference delegates and will offer more
in-depth presentations and discussions within particular fields
of knowledge. The EWMA 2015
full-day symposia includes the eHealth symposium, the joint EWMA-BSAC symposium, the joint
EWMA-JCN symposium as well
as the TVS symposium.
OU
SS
Expectations for this conference are high, as more than
800 abstracts have been submitted.
The conference offers more than 1,000 scientific presentations by international key speakers, free paper presenters, poster presenters, workshop facilitators, and satellite
symposium speakers. A record number of participants
(3,400+) are expected, and the exhibition is the largest in
the history of EWMA.
ment of Wound Care (AAWC). The title of the session is
“AAWC, Your International Partner, Presents: A Global
View of Wound Care: Past, Present, and Future.”
· CO
The 25th Conference of the European Wound Management Association (EWMA 2015) will be a historic event
in many ways. The scientific programme has expanded
significantly and will consist of various key sessions, workshops, lectures, full-day streams, and satellite symposia,
with scientists from Europe as well as the rest of the world.
The 2015 conference is organised in cooperation with the
Tissue Viability Society (TVS).
ND
· M A NA GE M E
NT
·A
With this symposium, EWMA focuses, for a third time,
on the ever-increasing role of eHealth and information
and communication technologies (ICT) in health care.
Specifically, the role of eHealth in wound care will be
emphasised.
Increasingly, eHealth is being introduced as an important
approach to solving the future challenges that our health
care systems will face. eHealth solutions are perceived as
essential tools to enable the provision of more care outside
hospitals and to facilitate interdisciplinary collaboration
and communication across units and sectors to optimise
continuity of care. We are currently witnessing the rapid
development of available technologies, with increasing
EWMA Journal 2015 vol 15 no 1
examples of regions and countries where eHealth is already
a part of their routine care. This will forever change the
way that care is delivered. The hope is that use of these
technologies will lead to more responsive care of higher
quality and at lower cost. It is now important to understand how this can be achieved.
This year’s eHealth symposium will examine state-of-theart eHealth services that are already in use in wound care,
as well as expectations for future health care systems. It will
delve into the need for organisational changes and shifts
in the roles and responsibilities of patients and healthcare
professionals in eHealth implementation and the delivery
of eHealth supported care. Finally, the programme will
present some of the recent technical developments in this
field. The programme will conclude with a wrap-up session
that aims to highlight the main conclusions of the day.
This session will also generate a discussion about ways of
moving towards the large-scale deployment of high quality
eHealth services in wound care.
To guide the audience through these topics, EWMA has
invited several leading experts, researchers, and experienced practitioners within the field of eHealth and wound
care.
to properly utilise clinical guidelines, and insufficient implementation of basic policies to promote rational use.
Infection is one of the most frequent complications in
wound management; consequently, antimicrobial agents
are readily used in the treatment of wounds. Alarmingly,
it is estimated that approximately 50% of antibiotic use
in both outpatient and inpatient settings is inappropriate.
In wound management, the use of topical antimicrobial
agents is particularly important, as the misuse of these
agents is believed to be as serious as the misuse of orally
or intravenously administered antibiotics. EWMA is dedicated to facing this challenge.
To strengthen our knowledge and educational power, we
have joined forces with the British Society for Antimicrobial Chemotherapy for this educational event.
EWMA SYMPOSIUM: CHALLENGE YOUR
PRACTICE: WOUND MANAGEMENT AND
DRESSING SELECTION IN THE COMMUNITY
This Nursing in the Community study day will give accessible, practical guidance on understanding, assessing,
and managing wounds. The attendees will be able to gain
a clear working knowledge of what needs to be done in
community care to achieve better outcomes.
JOINT SYMPOSIUM OF BSAC AND EWMA
Combatting antimicrobial misuse in Wound Care
The World Health Organization (WHO) has identified
key factors that contribute to the general misuse of antimicrobials: diagnostic uncertainty, lack of skills, failure
WORKSHOPS
n Skincare of patients with a chronic wound
n Improve mobility and independence with high-quality foot care - SOFTCAST HEEL PROTECTORS
n Evidence-based pressure ulcer risk assessment and implementation in clinical practice
nDebridement
n Cooperating Organisations Workshop
n Meet the experts: Everything you want to know about Maggot therapy
nBiofilm
nPodiatry
n Nutrition in wound care
n Designing a registry of wounds: the how and why
n Can Cochrane reviews inform your clinical decision making?
n Strategies for engaging students - support from new
technologies in the delivery of education
EWMA Journal 2015 vol 15 no 1
Let’s join forces to bring the European wound healing
community together in its mission to raise the awareness
of wound management and drive the wound management agenda forward across Europe. We look forward to
welcoming you in London!
www.ewma2015.org
PROGRAMME
HIGHLIGHTS
KEY SESSIONS
n Opening plenary session: Wound care - shaping the future - A patient, professional, provider, and payer perspective
n Living with non-healing wounds. Psychosocial concerns and
quality of life as patient-informed outcomes
n Pressure ulcer risk assessment: What do we know today?
n Wound care & geriatrics/Dementia in wound care
n Palliative wound care – Evidence-based practice for
managing challenging skin lesions
n Hard-to-heal wounds – a challenge for all involved
n Paediatric wound care
n Leg ulcer diagnosis and treatment – addressing the
challenges
n NPWT - where are we now, what are the controversies?
n Guidance document: eHealth in wound care - from
conception to implementation
87
EWMA
PROMOTING
ANTIMICROBIAL STEWARDSHIP
IN WOUND CARE
Infection is one of the most frequent complications in
wound management and, consequently, antimicrobial
agents are readily used in the treatment of wounds. Alarmingly, it is estimated that approximately 50% of antibiotic
use in both the outpatient and inpatient settings is inappropriate. It is a well-established fact that inappropriate use
and overuse of antimicrobial agents triggers the emergence
of resistant bacteria and causes patient harm. Patients with
antimicrobial-resistant infections are more likely to experience ineffective treatment, recurrent infection, delayed
recovery or even death.
The WHO has identified the following as key factors
contributing to the general misuse of antimicrobials1:
diagnostic uncertainty, lack of skills, failure to properly
utilise clinical guidelines and inadequate implementation
of basic policies to promote rational use1. For wound
management, the misuse of topical antimicrobial agents is
as serious as the misuse of antibiotics administered orally
or intravenously.
Antimicrobial stewardship programmes are increasingly
advocated as a means to decrease the misuse of antimicrobial agents. Along with infection prevention and control, hand hygiene and surveillance, antimicrobial stewardship is considered a key strategy in local and national
programmes to prevent the emergence of antimicrobial
resistance and reduce preventable healthcare-associated
infections.
EWMA’S ANTIMICROBIAL STEWARDSHIP PROGRAMME
Currently, there are no international or coordinated legislative or regulatory mandates designed to optimize the use
of antimicrobial therapy through antimicrobial stewardship. Given the societal value of antimicrobials and their
diminishing effectiveness due to antimicrobial resistance,
EWMA supports broad implementation of antimicrobial
stewardship.
88
PROGRAMME AIM
The overall aim of EWMA’s antimicrobial stewardship
programme is to reduce inappropriate use and overuse of
antimicrobials in wound care by promoting, facilitating
and teaching good antimicrobial practice. With a focus
on the health professional’s role in the area of appropriate
use of antimicrobials across health care settings, the programme is targeting not only health professionals involved
with wound care - doctors, nurses, pharmacists, microbiologists - but it is also reaching out to policy makers, such as
clinical administrators or managers at the local, regional
or national level. The aim is supported by the following
objectives and programme deliverables:
Treatment recommendations
n Development and publication of clinical treatment rec ommendations (decision support tools) that can be
used to stratify patients with infected wounds into
treatment groups at the point of care
n Establishment of expert consensus on key elements of
evidence-based best practice antimicrobial prescribing
n Development of recommendations for specific wound
types: diabetic foot ulcers, venous leg ulcers, and pres sure ulcers
Practical guide to implementation of
antimicrobial stewardship
n Development, publication and dissemination of a prac tical guide to antimicrobial stewardship in wound care
n Description of structural and organisational require ments to optimise antimicrobial treatment of wounds across all health care settings
Dissemination & education events
Development, planning and execution of an educa-
tional curriculum and educational events disseminat-
ing treatment recommendations and a practical guide
to antimicrobial stewardship
n Dedicated symposia at upcoming EWMA conferences
n Regional courses on antimicrobial stewardship in coln
EWMA Journal 2015 vol 15 no 1
laboration with EWMA Cooperating Organisations
and International Partner Organisations
n EWMA’s EU advocacy activities
As part of the EWMA antimicrobial stewardship programme, BSAC and EWMA will host a joint session on
antimicrobial wound management.
THE OBJECTIVES OF THE JOINT EWMA 2015
SYMPOSIUM ARE AS FOLLOWS:
n To enlighten the audience about the innovation and
best practices in prevention, diagnosis and treatment
of wound infections
n To educate the audience about the challenges of anti-
microbial resistance in wound care
n To inspire and prepare the audience to work with and
implement antimicrobial stewardship programmes
n The symposium is free of charge for all delegates with
a valid registration for EWMA 2015.
BRITISH SOCIETY
FOR ANTIMICROBIAL
CHEMOTHERAPY
(BSAC) /EWMA
JOINT SYMPOSIUM
Pisa International
Diabetic Foot Course,
30 September - 3 October 2015
Pisa, Italy
This 4 day theoretical course & practical
training gives participants a thorough introduction to all aspects of diagnosis, management and treatment of the diabetic foot.
Lectures will be combined with practical
­sessions held in the afternoon at the diabetic
foot clinic at the Pisa University Hospital.
Lectures will be in agreement with the
­International Consensus on the Diabetic Foot
& Practical Guideline on the Management
and Prevention on the Diabetic Foot.
NDORS
SE E
ED
UR
·
BY
· CO
Antimicrobial Stewardship in
Wound Management
Thursday 14th May, 14:15-17:55
EWMA Conference 2015, London
Management of
the Diabetic Foot
·
OU
SS
N
OC
IAT IO N
E U R OP EA
W
ND
· M A NA GE M E
NT
·A
This course is endorsed by EWMA.
Read more about the symposium here:
www.ewma2015.org/scientific/bsac-ewma-symposium.html
1. Medicines: rational use of medicines. Fact sheet number 338. 2010, World Health
Organization.
EWMA Journal 2015 vol 15 no 1
www.diabeticfootcourses.org
EWMA
2016
Bremen
SAVE THE DATES
11-13 MAY 2016
BREMEN · GERMANY
www.ewma.org
www.deutscher-wundkongress.de
www.wund-dach.org
·
BY
NDORS
SE E
ED
UR
·
W
OU
SS
N
OC
IAT IO N
E U R OP EA
EHEALTH IN WOUND CARE
- OVERVIEW AND KEY ISSUES TO
CONSIDER BEFORE IMPLEMENTATION
· CO
EWMA
ND
· M A NA GE M E
NT
·A
A joint document of the Australian Wound Management Association (AWMA),
Australia and the European Wound Management Association (EWMA), Europe.
The document is developed in connection with the United4Health project.
Published as an online supplement by the Journal of Wound Care
This document aims to provide wound care clinicians with a rapid and structured overview of the
key issues related to the use of eHealth applications (telemedicine and telehealth) within wound
care. This includes:
n An overview of the terminology and
available literature on this topic
n Guidance on the methodology for the
evaluation of eHealth solutions
n A discussion of the potential benefits
of eHealth technologies in wound care as
well as the possible barriers to their
implementation
n Recommendations for ensuring a good
implementation process
n Recommendations for supporting the
involvement of wound care professionals
in safeguarding that eHealth solutions
in wound care meet the needs of patients
METHODOLOGY
The layout of the document follows the structure
and focus areas of the Model for the Assessment
of Telemedicine (MAST), which defines crucial
items to address in the evaluation of an eHealth
application.
The content of the document is developed on the
basis of a literature review that identified available
documentation for the use of eHealth solutions in
wound care. Furthermore, the document draws on
various key documents that have been published
recently on the general development, evaluation,
and implementation of eHealth solutions. These
documents include valuable up-to-date information relevant to any group of clinicians who wish
to follow and influence the way eHealth solutions
are integrated into daily clinical practice.
EWMA Journal 2015 vol 15 no 1
FINDINGS AND CONCLUSIONS
The literature review revealed that the amount and
level of evidence for the use of eHealth applications in wound care remains limited. Some MAST
domains have not been examined in any of the
available studies. Thus, more research is required
to identify the potential benefits and harms to
patients as well as the possible challenges related
to the implementation of eHealth solutions in
wound care.
Zena Moore,
Document editor
Correspondence:
[email protected]
Potential barriers as well as facilitators for the
implementation of eHealth applications into
wound care practice are identified in the document, and these may either enhance or impede the
implementation process. However, the available
research on the use of eHealth care demonstrates
patient satisfaction; improved access to health
services for all client cohorts, including underprivileged groups; and increased job satisfaction
for clinicians.
The document recommends that wound care clinicians who are considering the use of eHealth
eHealth in

are
Wound C
Now available for free
download at
www.magonlinelibrary.com/page/
jowc/resources
n
plementatio
eption to im
From conc
www.ewma.org
ument
A joint doc
91
applications in their clinical practice should
consult widely and conduct regular evaluations
of the outcomes to ensure efficient implementation of these services.
To support this approach, some steps to ensure
a good implementation process within a given
organisation have been proposed. These steps
are synthesised into a three-level model and illustrate the areas demanding specific attention
in the different phases, ranging from initial considerations to actual implementation and the use
of the system in a clinical practice.
This model is illustrated in Figure 1. A more
detailed description of the model is provided
in the full document.
This document is published in connection with the
United4health project (www.united4health.eu).
Funding programme: ICT Policy Support Programme (ICT
PSP) as part of the Competitiveness and Innovation
Framework Programme by the European Commission.
Figure 1: What must be in place during the development and implementation
of an eHealth solution.
EWMA CONFERENCE 2015
eHealth Symposium
London · Thursday 14 May & Friday 15 May
eHealth in wound care – from the perspective of the health care professionals
OVERALL OBJECTIVE
With this symposium, EWMA focuses, for a third time, on the
ever-increasing role of eHealth and information and communication technologies (ICT) in health care in general and
wound care in particular.
This year’s eHealth symposium will examine the state of the
art of eHealth services already in use in wound care, as well
as expectations for future health care systems. It will delve into
the need for organisational changes and shifts in the roles and
responsibilities of the patients and healthcare professionals in
eHealth implementation and delivery of eHealth supported
care. Finally, the programme will present some of the recent
technical developments in this field. The programme will conclude with a wrap-up session aiming to highlight the main
conclusions of the day.
The purpose of the wrap up session is also to generate discussion about ways of moving forward towards the large-scale
deployment of high quality eHealth services in wound care.
PROGRAMME
THURSDAY 14 MAY
16.55 - 17.55
Key session: Guidance document on eHealth in wound care
FRIDAY 15 MAY
08.00 - 09.30
Remote assessment in wound care: Towards mature solutions and large-scale deployment
10.15 - 11.15
The healthcare system of the future – healthcare without borders
11.15 - 12.15
The organisational dimension of eHealth implementation
12.30 - 13.30
New technologies - new opportunities
14.15 - 15-15
Wrap up session: State of the art of eHealth in wound care
Read more about the symposium programme at
www.ewma2015.org/scientific/ehealth-symposium
The eHealth symposium is held in connection with the United4health project
www.united4health.eu
EWMA has invited some of the leading experts, researchers,
and experienced practitioners within the field of eHealth and
wound care to guide the audience through these topics.
EWMA Secretariat · Nordre Fasanvej 113, 2 · DK-2000 Frederiksberg · Denmark · www.ewma.org
EWMA NEWS
NEWS FROM CHRODIS-JA
EWMA is an associated partner in the Joint Action on Chronic diseases
(CHRODIS-JA) initiative by the European Commission, which has now been
working for 1 year. Represented by EWMA council member Prof. Alberto
Piaggesi EWMA in particular engages in the work package (WP) 7 which
addresses the challenge that the burden of diabetes places on the health
systems and individuals. The WP7 will as one of the tasks map data and
good practices on prevention of complications of type 2 diabetes – among
these diabetic foot ulcers.
During the first year a questionnaire on National Diabetes Plans has been
sent out. Currently answers from 21 countries are being processed and a
draft report on the contents of various National Diabetes Plans is being prepared. This will be followed by an analysis of the processes for prevention of
diabetes and complications used in the European Member States. Ultimately
the work will produce a guideline on how to make National Diabetes Plans
based on best practises content and process wise.
EWMA will participate in the next meeting of the WP 7 in Rome, 2-3 July,
2015.
EWMA PILOT PROJECT:
WOUND CENTRE ENDORSEMENTS
With the objective of developing a programme for the EWMA endorsement of wound centres, the EWMA has
initiated a pilot project targeting the endorsement of a wound centre at the Beida Hospital in Beijing, China.
A working group comprised of wound care clinicians with experience in developing wound care centres in different European countries will be responsible for defining the criteria and procedures for the endorsement of
wound centres. The pilot project, which is led by Prof. Finn Gottrup, will focus on wound centres based inside a
hospital, including an in-patient ward. However, EWMA also plans to develop specific criteria for wound centres
based outside the hospital.
A set of draft criteria has been developed and will be shared and discussed with the Chinese wound care centre
to ensure that the developed criteria match the reality of the centres targeted by the programme and meet the
standards defined by EWMA.
The pilot project is expected to be finalised in the autumn of 2015.
The members of the working group are: Hubert Vuagnat (Chair),
Finn Gottrup, Luc Gryson, Arkadiusz Jawien, and Severin Laüchli.
This project is supported by an unrestricted grant from the Coloplast Access to Health Care foundation.
EWMA Journal 2015 vol 15 no 1
93
LEG ULCER GUIDANCE
DOCUMENT
The EWMA Leg Ulcer Guidance initiative aims to
produce a practical guidance document that may
be applicable within different clinical settings for leg
ulcer treatment in Europe.
The working group responsible for this project started their initial planning of the project in February
2015, and the final document is planned for launch
during the EWMA 2016 Conference in Bremen, Germany, 11-13 May 2016.
The document will be developed in collaboration
with the Australian Wound Management Association (AWMA), and the document editors are Peter
Franks (UK) and Judith Barker (Australia, AWMA
representative). The author group also includes
Mark Collier (UK), Georgina Gethin (Ireland), Arkadiusz Jawien (Poland), Severin Läuchli (Switzerland),
Christine Moffatt (UK), and Sebastian Probst (Switzerland)
In relation to this initiative, a key session on leg
ulcers will be held at the EWMA 2015 conference.
This session will include an outline of the current
challenges related to the organisation of treatment,
as well as an introduction to the diagnosis and assessment of the different types of leg ulcers, by
members of the document author group.
The initiative is supported by unrestricted grants
from L&R/Activa and BSN Medical
EWMA Key Session:
EWMA Conference 2015, London
Leg ulcer diagnosis and treatment – addressing
the challenges
Thursday 12 May 16:55-17:55
SPECIAL SESSION FOR UNDERGRADUATE
STUDENT NURSES DURING THE EWMA 2015
CONFERENCE
Based on the success of previous years, a special
session intended for undergraduate student nurses
will take place during the EWMA 2015 Conference.
There has been such an overwhelming interest from
students from all over the UK that the event was
already fully booked in early April.
The session will give undergraduate student nurses
an introduction to wound management. For the
students, this will be a unique setting to receive an
introduction to the field of wound management in
general and pressure ulcers and diabetic foot ulcers
in particular, both on a national and international
level.
For the first time, one of the presentations during
the session will be given by an undergraduate nurse.
94
The presentation will be made by 3rd year nursing
student, Charlotte Johnston, who has successfully
arranged a pressure ulcer conference at the University of Lincoln and was named “Rising Star of the
Healthcare Sector”. Charlotte will talk about her
personal motivation and present the topic “Pressure
ulcer prevention: what can we do as students?”
Furthermore, representatives from both TVS and
EWMA will be represented at the session, and there
will be a presentation on international cooperation
and career opportunities within the field of wound
management.
The session will take place on Wednesday 13 May
from 15.30-16.30 pm.
www.ewma2015.org
EWMA Journal 2015 vol 15 no 1
EWMA NEWS
DEVELOPMENTS ON
THE NEW EWMA GUIDANCE
DOCUMENT ON NEGATIVE
PRESSURE WOUND THERAPY
In 2007, EWMA published a Position Document on
“Topical Negative Pressure in Wound Management”.
This document was focused on a single device, which
at that time was the main negative pressure wound
therapy (NPWT) device available on the market. Since
2007, the NPWT technology has advanced considerably, and a number of new devices and treatment applications have become available.
Against this background, a new EWMA guidance document on NPWT is being elaborated. The document
will be published in 2016 and presented at the EWMA
2016 conference in Bremen.
The first meeting of the author group was held at the
EWMA Secretariat on Sunday 22 February 2015. Here,
the content of the document was discussed and established. Secondly, an industry partner meeting was
held, where the document outline was presented and
discussed.
Among the major developments coming out of the
meeting were:
n The decision to include all three types of NPWT
within the document: on open wounds, with instilla tion, and over closed incisions. This approach en sures the most broadly relevant document with a
reach not seen earlier in the NPWT literature.
n Extensive coverage of specific factors and guidance
in terms of treatment of wounds with different aeti ologies and within different specialities such as
trauma, cardiovascular surgery, and problem
wounds.
n A special focus from the patient’s perspective.
EWMA Journal 2015 vol 15 no 1
n
A dedicated chapter on organisation, which will deal
with the cross-sectional possibilities and barriers including reimbursement structures and implementation.
The EWMA NPWT document author group is comprised of the following experts:
n Editor Jan Apelqvist, Immediate Past President, PhD,
Dr. med. (Sweden)
n Co-editor Christian Willy, Prof. Dr. med. (Germany)
n Ann-Mari Fagerdahl, RN, PhD (Sweden)
n Malin Malmsjö, Prof. Dr. med. (Sweden)
n Alberto Piagessi, Prof. Dr. med. (Italy)
n Astrid Probst, RN (Germany)
n Peter Vowden, Prof. Dr. med. (United Kingdom)
A key session will be held at the EWMA conference in
London, which will introduce and discuss important
elements from the document. In addition, a range of
dissemination and implementation activities is planned
following the document presentation at the EWMA
Conference in Bremen in 2016, which is expected to
strengthen the document’s impact and application.
The initiative is supported by unrestricted grants from
Acelity, BSN, Mölnlycke, Smith&Nephew, Spiracur.
EWMA Key session
EWMA Conference 2015, London
NPWT - Where are we now, what are the
controversies?
Friday 15 May 14:15-15:45
95
SWAN-iCare
The aim of the SWAN-iCare project is to develop a wearable device that allows for the monitoring and
personalised management of hard-to-heal diabetic foot ulcers and venous leg ulcers.
One key role of EWMA in the SWAN-iCare consortium is to facilitate the dissemination of information
to raise awareness about the project. This year, the annual EWMA conference in London will serve as
the central platform to disseminate information about the project to experts in the field of wound care.
EWMA has invited the SWAN-iCare consortium to introduce the project at a symposium dedicated to
eHealth from the perspective of the wound care professional. The project will be presented by Prof. Marco
Romanelli, MD, PhD, of the University of Pisa.
Members of the SWAN-iCare consortium also will attend the Focus Group meeting at the EWMA conference. The overall aim of the Focus Group meeting is for the SWAN-iCare consortium to obtain input
from potential end users regarding the product prototype. To facilitate this process EWMA will feature a
panel of wound care clinicians with expertise in the management of diabetic foot ulcers and venous leg
ulcers. The Focus Group meeting is seen as a strategic opportunity to gain independent validation and
sharpen the product specifications at a critical point of the development phase.
www.swan-icare.eu
NEW CONSENSUS
GUIDELINES FROM THE
INTERNATIONAL WORKING
GROUP ON THE DIABETIC FOOT
During the 7th International Symposium on the Diabetic Foot, May 20 – 23 in The Hague, Netherlands,
the International Working Group on the Diabetic
Foot (IWGDF) will launch their IWGDF Consensus
guidelines on the management and prevention of
the Diabetic Foot.
The guidelines, which are updated once every 4
years by experts on the various aspects of diabetic
foot syndrome, include practical and specific guidelines for topics such as: Footwear and Off-loading,
Infection, Wound Management, Prevention and
peripheral artery disease, Diagnosis and Prognosis.
The recommendations in the specific guidelines are
developed through the review of supporting scientific
evidence.
The purpose of these documents is to provide
guidelines that will reduce the impact of diabetic
foot disease via quality healthcare with considerations for cost and using the principles of evidencebased medicine augmented with expert opinion. The
intended audience for these guidelines is healthcare
professionals working with patients suffering from
diabetic foot syndrome or patients at risk for developing diabetic foot syndrome.
The guidelines are free of charge and published
both in print and online at www.iwgdf.org. The
guidelines are translated and published in English,
French, and Spanish.
The International Symposium on the Diabetic Foot, at which the updated guidelines will be
launched, is the world’s largest diabetic foot meeting, bringing together more than 1.200 experts from
around the world. See the Symposium program and
learn more at www.diabeticfoot.nl.
www.iwgdf.org
96
EWMA Journal 2015 vol 15 no 1
EWMA NEWS
Organisations
Report from the 6th
Pisa International Diabetic Foot Course 2014
Pisa
International
Diabetic
Foot Course
2014
Prof. Alberto Piaggesi
Director, Diabetic Foot
Section
University Hospital of Pisa
Correspondence:
[email protected]
www.diabeticfootcourses.org
The 6th International Diabetic Foot Course,
“Management of the Diabetic Foot”, was
held in Pisa, Italy, 1-4 October 2014.
38 participants from 18 different countries, 12
international faculty members and 16 national
faculty members, took part in the 2014 course.
Sharing this experience and interacting with
the most recognised international experts in
the field were highly valued by the participants.
The Diabetic Foot Course combines theory are
practical training. Theoretical lectures were
held in the mornings and practical workshops
with smaller groups were held in the afternoons in the specialised diabetic foot clinic at
the University Hospital of Pisa.
The course finished with a 2-hour long direct
transmission from the operating room, where
Alberto Piaggesi and his staff performed two
operations, which were commented on and
discussed live by two faculty members.
EWMA Journal 2015 vol 15 no 1
The results of an evaluation survey in addition
to general comments from the participants
during the course suggested great satisfaction
with the outcome of the course, emphasising
the benefits of combining practice and theory.
The 7th International Diabetic Foot Course
will be held again in Pisa, 30 September-3
October 2015. Additional information is available at www.diabeticfootcourses.org or from
the Course Secretariat at [email protected].
Participants and faculty members of the 2014 Course:
97
Organisations
EWMA international
Partner Organisation
THE WOUNDCARE KIT
-A KEY TOOL FOR WOUND
CARE IN A HUMANITARIAN
ENVIRONMENT
International organisations (such as UNICEF, HCR,
ICRC, and MSF (Doctors Without Borders)) commonly
use health or medical equipment kits to quickly respond
to the main medical or health situations they encounter
during their programmes.
A kit is a set of elements selected for a definite task and assembled in a box. It is designed to enable a quick response
during emergency. It must be reliable, relatively cheap
and bring rapidly all the elements needed in a definite
emergency situation in settings with limited resources.
WAWLC representatives presenting the wound care kit in Toronto
31 Oct 2014: From left: John Macdonald, David Keast, Hubert
Vuagnat, Terry Treadwell, Eric Comte.
A wound care kit will consist of a box containing the basic necessary supplies needed to treat wounds at a health
centre level.
reduced to 36 items, was set and communicated during
the 20th annual conference of the Canadian Association
for Wound Care November 2014.
The conception of the actual wound care kits used by different international organisations dates back more than 20
years and does not consider the new knowledge acquired
during these last decades in wound care and wound healing.
The next step, beginning right now, is the physical constitution of this new kit. This prototype will allow us to
have a better estimate of its volume, weight and price.
Furthermore, it will allow us to think of the packaging.
A new wound care kit encompasses the concept of
“advanced wound care” and will be a dynamic tool
to:
n Provide basic equipment for wound care
n Harmonise training with a standardised list of
medical goods
n Facilitate budget calculation both for fund
providers and the organisations themselves
n Facilitate deployment in emergency situations
n Facilitate negotiations with industrial firms to gain
the best commercial conditions
Since a little more than two years, a working group of the
World Alliance for Wounds and Lymphedema Care (www.
wawlc.org), has organised workshops to obtain an expert
consensus on the kit content. During two workshops held
during EWMA’s 2013 (Copenhagen) and 2014 (Madrid)
conferences and further work through the internet, an
initial 42-item list was retained. From this list a second list,
98
Next, with a partner, 15 kits will be made and sent to
3 pilot sites familiar with modern wound care (two in
Africa, one in Haiti). This pilot phase will allow the necessary adaptations that will lead to a final 10-month-long
test phase. At the end of this process, through the lessons
gained, the definitive kit will be constituted.
Collaboration with industry is still open and will be
crucial in the realisation of the kit.
For any questions, please do not
hesitate to contact the authors.
n Hubert Vuagnat
[email protected],
n
Eric Comte,
[email protected]
EWMA Journal 2015 vol 15 no 1
Kit items:
Gauze and dressing
WAWLC was officially launched as a global partnership encouraged by the WHO in 2009. Read more about WAWLC activities
at www.wawlc.org. WAWLC is an international partner organisation of EWMA.
1
Non-woven gauze, sterile
2
Non-woven gauze, non-sterile
3
Paraffin gauze, sterile
4
Transparent polyurethane film
Bandaging
5
Cohesive bandage
6
Under cast padding, roll
7
Crêpe bandage
Tape
WALWC SESSION AT
EWMA 2015
At the EWMA conference in London, a WAWLC guest
session will be held with the title “Update on WAWLC
Activities in Resource-limited Settings.” The session will
feature an update on the kit development process.
8
2-cm adhesive tape roll
9
10-cm adhesive tape roll
Cream and ointment
10
Vaseline cream
11
Silver sulphadiazine
Hygiene and disinfectant
12
Sterile saline
13
Liquid soap
14
Polyvidone iodine, 10%, solution
15
Alcohol gel hand rub with dispenser
16
Disposable gloves, non-sterile
17
Scalpel blade, scalpel
18
Scalpel blade, scalpel with handle
19
Syringe 20 ml
20
Disposable drapes
21
Easy-to-use wound care protocols
REFERENCES
22
Marker pen
1. Guidelines for medicine donations. WHO. Geneva. Third Edition 2011.
23
Individual patient record
24
Paper tape rules
Time: Wednesday 13 May 13.45-15.00
Place: Platinum 5
Chairs: David Keast, Hubert Vuagnat
Material
Writing and paper
2. Kit System Management. (Managing Access to Medicines and Health Technologies,
Chapter 26). WHO. Geneva. 2012. http://apps.who.int/medicinedocs/documents/
s19603en/s19603en.pdf. [Accessed 24.06.2012]
The authors would like to thank the rest of the working group: Kingsley Asiedu, Robyn
Björk, David Keast, Jan Kristensen, John Macdonald, Terry Treadwell and, of course, all
of the other individuals who contributed to this work.
EWMA Journal 2015 vol 15 no 1
Waste disposal
25
Sharp container
26
Plastic waste bag
99
Obituary
20 April 2015
Visit EWMA
on our
Social Media
platforms
Follow us and get the latest
­updates about
EWMA activities:
www.facebook.com/
EWMA.Wound
www.linkedin.com/company/
european-wound-managementassociation
Twitter: @ewmatweet
GRAPHIC DESIGNER OF
EWMA JOURNAL SINCE 2001,
BIRGITTE CLEMATIDE
It is with great sorrow that we have received the
information about Birgitte Clematide’s death a
few days ago.
Birgitte has been the most important person
behind EWMA’s graphical design for the past 15
years.
She created the design for EWMA Stockholm
2000, the new EWMA logo in 2000 and the first
EWMA Journal in 2001.
Since then, she has been instrumental in the
graphic design for all EWMA Journals and conference programmes.
Her original expression helped define the characteristic and easily recognizable profile of EWMA
and the EWMA conferences. Hers was a talent
combined by the critical curiosity of the academic,
the great imagination of the artist and the professionalism of the craftsman.
She will be missed by everyone involved in EWMA.
On behalf of
The European Wound Management Association
(EWMA)
Instagram: @ewmapics
100
EWMA Journal 2015 vol 15 no 1
EWMA NEWS
Organisations
AWMA NEWS
AWMA
Australian
Wound
Management
Association
Margo Asimus,
AWMA President
It is with great pleasure that I have been offered this
opportunity to introduce myself to the EWMA membership. In May 2014, I was appointed AWMA
President. For over 20 years, I have enjoyed being
involved in the specialty of wound management,
first as a stomal therapist/wound specialist/infection
control officer in the acute system that inspired a
goal to become a nurse practitioner in the community setting consulting in high-risk, communitybased clinics from 2004. Since 2012, I have worked
as Vice President for AWMA alongside our now
immediate past president Bill McGuiness.
In the second half of 2014, the AWMA committee
was closely aligned to the strategic direction and
focused activity in identified key result areas
(KRAs). Each area has executive leadership with
the following defined objectives:
1.Profile
2.Growth
3.Governance
4. Education & Research
5.Nationalisation
Jane Andrews
Deputy CEO,
Wound
Management
Innovations
CRC Australia
www.awma.com.au
The WMI CRC is a joint venture involving 20 participating industry, academic and end-user organisations with a shared vision of transforming wound
outcomes. The WMI CRC has four operational areas, including research, development, clinical translation and education. The WMI CRC was established in 2010 with over $100 million dollars of
cash and in-kind contributions from the Australian
Government and WMI CRC participants.
The partnerships and relationships between AWMA
and WMI CRC continue to grow stronger as our collaborations and synergies forge ahead, and we
strive together to achieve great results in key areas.
2015–2016 will bring some significant changes to
AWMA as we know it today. However, as we continue to increase membership, undertake political
lobbying, collaborate with our international partners
and conduct awareness campaigns, we must move
away from a hard-working voluntary organisation to
a business that functions efficiently and grows to
meet the needs of Australians. I look forward to
leading this challenge together with our motivated
AWMA committee and partnership from the WMI
CRC.
Establishing this framework has moved AWMA closer to a portfolio structure in preparation for Nationalisation when it occurs later this year.
In addition to the KRA activities, AWMA subcommittees have been very productive in planning
projects that are scheduled for completion over the
next 12 months:
n Australian and New Zealand Clinical Practice
Guidelines for the Prevention and Management
of Venous Leg Ulcers revision
n Wound Aseptic Technique position documents
n Australian Wound Management Association
Standards revision
n Wound Awareness Campaign (August launch)
The Wound Management Innovation CRC (WMI
CRC) is working with AWMA on characterising the
dimensions of Australia’s wound problems by establishing a National Wound Registry. Clinical registers
are recognised as efficient tools to improve health
outcomes and to reduce direct health costs. In
addition, the WMI CRC and AWMA will be jointly
launching a patient awareness campaign to ensure
that people with wounds are directed to the most
appropriate resources.
EWMA international
Partner Organisation
EWMA Journal 2015 vol 15 no 1
101
Organisations
AAWC NEWS
AAWC
Association for
the Advancement
of Wound Care
Dear Colleagues and Friends at EWMA,
The Association for the Advancement of Wound
Care (AAWC) is pleased to update the readers of
the EWMA Journal. The year 2015 commemorates
the historical and successful evolution of AAWC as
we celebrate its 20th Anniversary.
Much like EWMA, a diverse interprofessional membership and the patients we serve are our inspiration. It is diversity that keeps our organisations
strong! Since my last report, AAWC has flourished
both in sustaining membership and significantly
increasing sponsorship support.
Vickie R. Driver
President of AAWC
ABOUT AAWC
As the leading interpro­
fessional organisation in the
United States dedicated to
advancing the care of
­people with and at risk for
wounds, AAWC provides
a whole year of valuable
benefits! Be sure to join us
for near daily updates and
alerts on Facebook
and LinkedIn.
www.aawconline.org
EWMA international
Partner Organisation
102
AAWC continues as the host society, along with
WHS as co-host, for the multi-societal initiative in
the US entitled “Wound-care Experts/FDA—Clinical
Endpoints Project (WEF-CEP)”. Because “complete
closure” is the only current endpoint that the US
Food and Drug Administration (FDA) uses to determine drug and device therapy approvals, our teams
are developing a new set of clinical endpoints to
propose to the FDA—additional endpoints that are
meaningful to our patients.
In the spirit of collaboration, we are working with
the Wound Healing Society, as well as experts in
Canada and Mexico, to evaluate the intricate process for combining multiple guidelines over the next
few years. While each wound care association
involved will continue to advance its own important
mission for our field, AAWC’s vision is that one day
there will be one set of resources supported by tens
of thousands of multidisciplinary, collaborative, professional organisation members.
HELP SHA
PE OUR F
IELD!
Attend the
AAWC’s
20th Anniv
ersary Mem
bership Me
eting
at the Sym
posium on
Advanced
Wound Ca
re (SAWC)
San Anton
io, US,
April 30 May 3, 20
15
You also will not want to miss the AAWC 20th
Anniversary Celebration on Friday from 8:30 PM –
10:30 PM. Special gifts will be provided, and there
will be exciting announcements, including the presentation of the 2015 AAWC Distinguished Member
Award! Enjoy door prizes, food, drinks, live DJ
music, dancing and fun! We thank SAWC for sponsoring this delightful fiesta-style party!
I would be remiss not to mention our Association
board members, volunteer committee chairs, members and staff who are monumental contributors to
our success. Last but not least, we are proud to be
represented by over 70 members from more than
30 countries. The AAWC thanks all of its multidisciplinary members and warmly invites all EWMA
readers to join AAWC.
SAWC Spring in San Antonio, April 30-May 3 will
be the most exciting US symposium in years. Not
only are we celebrating the Association’s 20th
Anniversary but also we are launching the inaugural AAWC Clinical Practice Track. We hope you will
choose some or all of these sessions as you create
your personalised SAWC schedule.
AAWC is hard at work shaping the field of wound
care as an advocate for this profession and our
patients. We are already working for you—why not
make it official and join? Together, we can advance
the practice of wound care.
If you will be attending SAWC Spring, please join us
at our 20th Anniversary Membership Meeting:
“Help Shape Our Field!” on Friday from 6 PM –
7:15 PM. This will be an interactive meeting where
we will recount the great strides forward AAWC has
made over the last 20 years. Join us to learn more
about our current initiatives and exciting upcoming
plans.
Dr. Vickie R. Driver
President, AAWC
Sincerely,
EWMA Journal 2015 vol 15 no 1
EWMA NEWS
Organisations
RESPONSE TO THE
CHALLENGES OF CHRONIC
WOUND DISEASES:
CTRS’S ACTION
Prof. Xiaobing Fu
President of CTRS
CTRS is a new
EWMA international
Partner Organisation
www.chinese-trs.com/en
EWMA international
Partner Organisation
EWMA Journal Currently, in China, economic improvement has
been accompanied by a great change in lifestyle,
along with an increasing incidence of chronic diseases. In 1998, a multicentre epidemiological study
on inpatients with chronic wounds indicated that
the leading cause of chronic cutaneous wounds
was trauma (67%), with a low frequency of diabetic
foot ulcers (DFUs; <5%). Ten years later, the leading causes of chronic cutaneous wounds were
DFUs (32.6%), trauma/burns (23.8%), iatrogenic
factors (10.6%) and pressure ulcers (10.5%). This
result is directly proportional to the high morbidity
of diabetes in China. The prevalence of diabetes
changed from 2.5% in 1994 to 5.5% in 2001 and
reached 9.7% in 2008. Regarding the worldwide
average morbidity of DFUs (15%), China has an
estimated prevalence of at least 100 million adults
with diabetes, for about 15 million patients with
DFUs.
Another focus of CTRS is addressing the training
issue. CTRS has developed a 3-year training programme in wound care in China that is sponsored
by the World Diabetes Foundation and Coloplast
Access to Healthcare foundation. The project
focuses on training physicians and nurses in wound
care for patients with diabetic mellitus and other
chronic skin wounds. In the past 2 years, 1,618
health care professionals, including 915 physicians
and 703 nurses, have been trained. Participants are
from more than 200 hospitals in 21 provinces.
About 1,200 patients per month on average have
benefited from this project. In total, 13 hospitals
have become training bases to continue the education program. The aim of the program is to help
Chinese medical professionals efficiently manage
chronic wounds, thereby shortening the wound
healing time, reducing the amputation rate and
treatment costs, and improving the quality of life.
Chronic wounds such as DFUs, pressure ulcers, and
leg ulcers take a long time to heal and can be
accompanied by high disability. Such ulcers seriously affect the quality of life of patients and have a
heavy burden on social security. Just several years
ago, China had only a few wound care units or
wards in hospitals where health care professionals
can provide systematic treatment with advanced
knowledge and new technology on wound care. As
one of the examples, most Chinese patients with
DFUs see physicians in different departments, such
as endocrinology, orthopaedic, vascular surgery,
general surgery, trauma surgery, burns and plastic
surgery, dermatology, and emergency departments.
Thus, the therapeutic results can vary greatly
because of a lack of knowledge and limited technology in different departments.
Another training program specifically for GP and G
nurses from Shanghai Community Health Care
Centres was completed in 2013. More than 200
participants have joined the programmes with 4
training courses.
To cope with the challenge, the Chinese Tissue
Repair Society (CTRS) has been making great
efforts to promote the development of wound healing in China and is endowed with multidisciplines
and specialisations. The vision is to improve wound
management, and the strategy is to offer concerted
care while continuing to pursue research excellence
into the understanding of disease pathology and
exploring the role of technologies.
2015 vol 15 no 1
The training project led by CTRS covered the eastern half of
the country.
103
Organisations
ELCOS
Sociedade de
Feridas
Kátia Furtado
ELCOS President
Tânia Santos
ELCOS Assembly
ELCOS is a new
EWMA Cooperating
Organisation
EWMA
Cooperating Organisation
www.sociedadeferidas.pt
104
ELCOS
Portuguese Wound
Society - an innovative
approach
ELCOS is a scientific society that assembles professionals from different areas (health, education and
research) who have a common interest in promoting the discussion, training and research in tissue
viability and wound care. Currently, there are 720
members comprising nurses, physicians, physiotherapists, psychologists, nutritionists, and pharmacists.
The founders of ELCOS include some co-founders
and representatives of counterpart organisations at
the national and international levels who intended
to embody a project on the national scene: an
organisation with the ultimate aim of promoting
public health.
This initial group, with multidisciplinary training
acquired in Portugal and abroad (in the fields of
nursing, chronic wounds, nutrition, psychology, and
health facilities management), all with specialised
training in community health, launched the project
that was anchored along political lines and was
clearly defined in its mission, vision and values.
Ambitious but conscious, with policy outlined in its
limits, the founding group invited the ELCOS Board
and its departments and regional councils comprised of different professionals. All have in common the interest to promote and/or support educational, technical, scientific, ethical and research initiatives in the prevention and treatment of wounds,
thus covering clinical practice, teaching and scientific research. Therefore, the human capital of
ELCOS consists of professionals at various levels in
the scientific community: physicians (specialists in
general surgery, vascular, plastic, endocrinology
and dermatology), nurses (specialists in various areas), pharmacists, engineers specialising in media
applied to the areas of telemedicine and university
teachers.
The board members and regional councils consist
of a cast with scientific knowledge (with bachelors,
masters, and doctorates), ensuring sustained activity in terms of research training, with representation
at the level of the EPUAP, EWMA and WHO. To
fulfil its goal, the ELCOS-Portuguese Healing Society and the Study and Research Wound Centre are
organised geographically into regional councils,
aiming to address regional nosology in terms of
chronic wounds through the involvement of interested professionals in each region, in partnership
with health and education institutions at a local level.
We intend to identify in each region the existing
nosology in terms of chronic wounds, the incidence
and prevalence, human resources, and knowledge
to develop a regional action plan that allows sustained work developed in partnership with institutions to respond in a directed way to the specific
problems of each region. In this task to eradicate
the disease within the context of poverty in which so
many times it appears we follow the words of the
General Director of WHO (1983): “Everyone is on
and has the power to change things: citizens of the
villages and cities, families and communities and all
sorts of political and social groups, such as education and research institutions, non-governmental
organizations and professional associations. But
also health experts and those responsible for the
community, such as civil and religious leaders,
teachers, judges, workers of social security.”
Without the deep involvement of the entire population, health for all will always be a mirage.
Every year, ELCOS holds an annual Iberian Forum
of Ulcers and Wounds in a different city and, this
year (2015), the VI Iberian Forum will occur in Lisbon. Furthermore, and following the mission of covering clinical practice, teaching and scientific
research in partnership with health and education
institutions, we will conduct Post Graduate Courses
in Tissue Viability in partnership with universities
throughout Portugal and Basic and Advanced
Courses in Wound Management in partnership with
health institutions.
In 2014, following the agenda led by the International Diabetes Federation and joining the global
diabetes community to produce a powerful voice for
diabetes awareness and advocacy, we organised
the 1st Iberian Symposium in Diabetes, and it was
a success with the presence of national and international economists, politicians and health professionals.
By joining ELCOS, members receive a discount at
our annual Forum and in so many other activities
that we develop. For instance, we have published a
Wound Dressing book in 2012, and we are completing another book on debridement that will be
launched in March 2015.
All publications are free
for ELCOS members.
For more information, please visit
us at www.sociedadeferidas.pt
EWMA Journal 2015 vol 15 no 1
EWMA 2016
BREMEN · DE
11-13 MAY 2016
THE EWMA UNIVERSITY
CONFERENCE MODEL (UCM)
IN BREMEN
The EWMA UCM programme offers students of
wound management from institutes of higher
education across Europe the opportunity to take
part of their academic studies whilst participating in
the EWMA Conference.
The opportunity of participating in the EWMA UCM
is available to all teaching institutions with wound
­management courses for health professionals.
The UCM programme at the EWMA 2016 Conference in ­Bremen will offer networking o
­ pportunities
between the students from various UCM groups,
UCM Lectures as well as assignments and workshops arranged specifically for the UCM students.
EWMA strongly encourages teaching institutions
and students from all countries to benefit from the
possibilities of international networking and access
to lectures by many of the most experienced wound
management experts in the world.
PARTICIPATING INSTITUTIONS:
Donau Universität Krems
Austria
Haute École de Santé
Geneva, Switzerland
HUB Brussels
Belgium
Lithuanian University of Health Sciences
Lithuania
University of Hertfordshire
United Kingdom
Universidade Católica Portuguesa
Porto, Portugal
Yours sincerely
Dubravko Huljev
Chair of the Education Committee
For further information about the EWMA UCM, please visit the
Education section of the EWMA website www.ewma.org or contact the
EWMA Secretariat at [email protected]
Make a difference in clinical practice
Become a Member of EWMA
Benefits of your EWMA Membership:
n You make a difference in clinical practice within wound management in Europe
n Right to vote and stand for EWMA Council
n EWMA Journal sent directly to you two times a year
n EWMA news and statements sent directly to you
n A discount on your registration fee for EWMA Conferences
n Right to apply for EWMA travel grants
n Yearly membership fee € 25
n Yearly membership fee for members of cooperating organisations € 10
EWMA Journal 2015 vol 15 no 1
105
Organisations
SLOVAK WOUND
HEALING SOCIETY
SLOVAK
WOUND
HEALING
SOCIETY
Associate Professor Jan
Koller, M.D., Ph.D.
SSPLR President
SSPLR is a new
EWMA Cooperating
Organisation
EWMA
Cooperating Organisation
INTRODUCTION
The Slovak Wound Healing Society (SSPLR ) was
founded in 2012 as a professional association of
health care professionals dealing with the management and care of both acute and chronic wounds
of different origin. SSPLR, following its establishment, applied and was accepted as an organisational unit of the Slovak Medical Association
(SkMA).
MISSION AND OBJECTIVES OF SSPLR
n SSPLR is an association of health care profes sionals who participate in the management and
care of acute and chronic wounds of different
aetiology
n SSPLR aims to comprehensively solve both
health and social care problems in the area of
wound management
n SSPLR aims to transfer the latest scientific,
professional, medical, diagnostic and therapeu tic knowledge into practice in continuous medi cal education and practical training activities
n SSPLR shall assert a decisive role in the prepara tion of professional standards for wound care at
the hospital, outpatient and home care levels
n SSPLR shall initiate, submit, enforce and publish
professional opinions on the following:
- issues pertaining to expertise and scientifi cally based knowledge of wound management
- ethical issues for physicians and other health
care professionals
- issues related to existing and preparing
regulatory standards and professional
opinions in health care
- nominations of experts as members of various
committees
n SSPLR shall nominate members to represent the
society in international professional wound care
associations, particularly in the EWMA Coope rating Organisations.
INFORMATION CONCERNING PAST OR
UPCOMING CONFERENCES/MEETINGS
Since its establishment, SSPLR has participated
actively in several wound healing sessions at national scientific meetings of other SkMA professional
associations such as the Annual Conference of the
Slovak Angiology Society in 2013 and the Slovak
Surgical Society in 2013 and 2014. SSPLR provided
scientific guarantee and lecturers for two wound
healing scientific workshops in the year 2013 and
three in 2014. At least two more such workshops
are scheduled to occur in February and April 2015.
Members of SSPLR actively participated presenting
lectures and posters at the EWMA conferences in
2013 and 2014. Active participation is also expected at the 2015 EWMA annual conference in London.
DESCRIPTION OF RESEARCH PROJECTS IN
WOUND HEALING OR WOUND MANAGEMENT
SSPLR is planning to initiate educational programmes in wound healing management at the
national level in Slovakia in the very near future.
EWMA position documents are being translated
into the Slovak language. A continuous education
programme also using EWMA position documents
for all levels of wound healing professionals is in
preparation. The next step is the preparation of
national guidelines for wound management in Slovakia.
Presentation of the opportunities and challenges
within the organisation of wound care in Slovakia
As in other countries, many problems exist in the
management of chronic wounds such as leg ulcers,
diabetic ulcers and pressure sores. Regarding the
novel treatment methods and use of advanced
medical devices for chronic wound treatment, some
are fully reimbursed, while others are partially reimbursed by health care insurance companies.
The most important challenges of SSPLR in the
near future include the initiation of educational
activities in wound management along with setting
up wound healing facilities at regional levels. The
continuing medical education programmes will be
organised at a level for physicians, as well as at a
level for nurses, on regional principles to enable
easier participation of all health care personnel
engaged in wound management in the activities.
All of the continuing medical education seminars
and practical courses will be accredited and organised, according to national CME regulations, in
cooperation with the Slovak Accreditation Council
for Continuing Medical Education. We are also
expecting an even closer cooperation with EWMA
and the EWMA Cooperating Organisations in this
field.
www.ssplr.sk/en
106
EWMA Journal 2015 vol 15 no 1
HELLENIC SOCIETY OF
WOUND HEALING
THE HELLENIC
SOCIETY
OF WOUND
HEALING
Georgia Koulermou,
President of HSWH, MD,
PhD, Director of the Department of Plastic Surgery and
Burns, Nicosia General
Hospital, Hon. Professor of
Plastic Surgery
The Hellenic Society of Wound Healing and Chronic Ulcers (HSWH) was founded in 2003 as a scientific non-profit association. The Society is based in
Athens but also has members from other Hellenic
cities all over Greece and from Cyprus. The main
aims and objectives of the Society are:
n To cooperate closely with the relevant national
and European authorities to improve the services
to patients with chronic and acute tissue deficits
n To reduce the psychosocial effects created by
these deficits
n To promote prevention by giving best training on
health professionals.
n The reduction of treatment costs
n The improvement of quality of life of these
patients
n To promote continuing education, both health
professionals and the public concerned by
organising educational events
n To contribute in establishing cooperation
between national professionals and international
organisations
n To promote research in this area, having the
ability for sponsored research programs
n To provide advisory and educational services to
patients and their relatives, agencies and health
care professionals
n To improve wound care standards, according to
the international guidelines, for patients
HSWH works to achieve these objectives through
encouragement and guidance of research, particularly among young scientists, as well as through the
systematisation of knowledge concerning chronic
and acute trauma in Greece, and the supervision
and execution of postgraduate and continuing education programs.
HSWH is a new
EWMA Cooperating
Organisation
EWMA
Cooperating Organisation
ACTIVITIES
Between 2003 and 2013, HSWH has organised the
National Would Healing Conference, which occurs
bi-annually with 500–1000 participants.
During the National Congress, the “Ioannovich
Award” is given to the best scientific presentation.
Furthermore, HSWH offers four to five scholarships
for young scientists to follow a programme at
wound healing centres abroad.
HSWH is often invited to national and international scientific conferences; among these are the
Annual National Conference of Hellenic Association of Nurses (ESNE) and the Annual National
Conference of Hellenic Doctors (PIS).
Furthermore, HSWH have been invited to organise several workshops at hospitals of the public, military and private sectors, as well as to co-organise
several educational programmes at the Plastic Surgery department and Burn Center of Nicosia General Hospital in Cyprus focusing on the prevention
of pressure ulcers.
HSWH has co-organised meetings with the Mediterranean Council for Burns and Fire Disasters
(MCB) and European Tissue Repair Society (ETRS),
as well as supported seminars for European Academy of Wound Technology (EAWT).
Moreover, HSWH performed a Practical Training
Program in collaboration with the World Union of
Wound Healing Societies (WUWHS) and organised
five workshops of Advanced Burn Life Support
(ABLS).
In 2012, HSWH co-organised an EAWT
approved Summer School that also focused on the
prevention of pressure ulcers.
RESEARCH EFFORTS
In January 2007, HSWH organised the first national
pressure ulcer prevalence study in which approximately 30 hospitals all over Greece participated,
and the prevalence was found to be 8,08%. The future plans and objectives are important for
the board. HSWH will continue the engagement in
new and existing research activities and collaborations with Greek and International Scientific Societies. In addition, the elaboration of guidelines for
health care professionals is planned for the near
future.
HSWH has established an excellent level of collaboration with the industry, which is considered an
important partner in the dissemination of knowledge concerning wound healing and wound management. Any advice, comments or criticisms
offered by the industry are reviewed by the academic and clinical partners in the organisation.
The area of wound care in Greece leaves much
to be desired because reforms and economic
restraints result in decreasing budgets in all sectors
of the Greek healthcare system, including the
wound healing sector. Also, the lack of specialised
centres is considered a challenge for the advancement of wound healing in Greece.
Finally, even more improvement could be made
within education and research in wound healing in
our country—for example, by creating a masters
degree in the area of Advanced Wound Management.
www.hswh.gr
EWMA Journal 2015 vol 15 no 1
107
EWMA
Corporate Sponsors
Corporate A
ConvaTec Europe
www.convatec.com
acelity
www.acelity.com
BSN medical GmbH
www.bsnmedical.com
www.cutimed.com
Coloplast
www.coloplast.com
Flen Pharma NV
www.flenpharma.com
PAUL HARTMANN AG
www.hartmann.info
Lohmann & Rauscher
www.lohmann-rauscher.com
Mölnlycke Health Care Ab
www.molnlycke.com
Ferris Mfg. Corp.
www.PolyMem.eu
Wound Management
Smith & Nephew Medical Ltd
www.smith-nephew.com/wound
sorbion GmbH & Co. KG
www.sorbion.com
Corporate B
3M Health Care
www.mmm.com
SastoMed
www.sastomed.com
Chemviron
www.chemvironcarbon.com
ABIGO Medical AB
www.abigo.se
Boyd Technologies
www.boydtech.com
DryMax
www.absorbest.se/
drymax-woundcare
KLOX Technologies Inc
www.kloxtechnologies.com
Laboratoires Urgo
www.urgo.com
SOFAR S.p.A.
www.sofarfarm.it
Welcare Industries SPA
www.welcaremedical.com
Söring Gmb
www.soering.com
Stryker
www.stryker.com
B. Braun Medical
www.bbraun.com
Nutricia Advanced
Medical Nutrition
www.nutricia.com
108
EWMA Journal 2015 vol 15 no 1
Organisations
Conference Calendar
Conferences 2015
Theme
Annual Meeting of Swedish Wound Care Nurses Association (SSiS)
Spring Symposium on Advanced Wound Care
and Wound Healing Society (SAWC)
Month
Days
City
Country
Medical techniques in wound April
diagnostics and wound treatment.
20-21
Stockholm
Sweden
Interdisciplinary Diabetic Foot, Amputation Prevention, PAD and
Wound Care
29 -3 ‘San Antonio, TXUSA
April-May
Deutscher Pflegekongress / Deutscher Wundkongres
May
6-8
Bremen
Germany
25th Conference of the European Wound
Management Association (EWMA)
London
United Kingdom
7th International Symposium on the Diabetic Foot (ISDF)
May
20-23
7th Annual Conference 2015 of the
Wound Care
May
21-23
New Zealand Wound Care Society (NZWCS)
– A Matter of Balance
16th European Federation of National Infection
May
27-29
Associations of Orthopaedics and Traumatology
(EFORT) Congress
The Hague
The Netherlands
Blenheim
New Zealand
Prague
Czech Republic
Annual congress of the Swiss Association for Woundcare (SAfW Romande)
May 28
Morges
Switzerland
27th National Congress of the Spanish Association of Vascular Nursing and Wounds (AEEVH)
June
4-5 Castellon
Spain
Rande 2015
Wound Healing & Tissue Repair June
11-12
18. Jahreskongress (DGfW)
June
18-20
Trinec
Czech Republic
Ludwigshafen
Germany
34th Annual Congress of European Bone and Joint Infection Society (EBJIS)
September
10-12
18th Annual European Pressure Ulcer Advisory Putting the Pressure
September
16-18
Panel Meeting (EPUAP)
in the Heart of Europe
Estoril, Lisboa
Portugal
Ghent
Belgium
16th European Burns Association Congress (EBA)
September
16-19
Hannover Germany
Eliminating Heel Pressure Ulcers September
24
London
UK
“WOUND CARE – SHAPING THE FUTURE A PATIENT,
PROFESSIONAL, PROVIDER
AND PAYER PERSPECTIVE”
May
13-15
The 15th Annual Leg Club Conference
Handle with Care. Head to Toe
September
23-24 Aspects of Wound Healing
DEBRA International Annual Congress
September
25-26
Worcester Rugby Club UK
London
UK
Society of Advanced Wound Care Fall Symposium (SAWC)
The Pisa International Diabetic Management of the
Foot Courses 2015
Diabetic Foot
September
26-28
Las Vegas
United States
September-
October 30-3
Pisa
Italy
17th Annual Meeting of the Austrian Wound Association (AWA)
October
2-3
13th Annual Congress of the Italian Association October
7-10
for the study of Cutanecus Ulcers (AIUC)
St. Pölten
Austria
Bari, Fiera
Italy
24th Conf. of the European Academy of Dermatology and Venereology (EADV)
October
7-11
National Multidisciplinary Congress (NOVW)
Trilogy about Wounds
October
13
Copenhagen
Denmark
Ede
Netherlands
7th Joint Meeting of ETRS & WHS
Copenhagen
Denmark
‘From Bed to Bench’
October
21-23
21st Annual Conference of Canadian Association of Wound Care (CAWC)
Oct-Nov
29-1
Toronto
Canada
VIII Ibero-Latin American Congress about Ulcers and Wounds (SILAUHE)
November
11-13
Mérida
Mexico
Together - Smarter in Woundcare November
24-25 Utrecht
The Netherlands
15th Congress of the Wound Care Society (WCS)
11th Annual Conference of Ukraine Wound Treatment Organisation (UWTO)
November
26-28 Kiev
Ukraine
Annual Meeting of Danish Wound Healing Society (DSFS)
November
27-28
Billund
Denmark
For web addresses please visit www.ewma.org
EWMA Journal 2015 vol 15 no 1
109
Cooperating Organisations
CSLR
Czech Wound Management Society
www.cslr.cz
AEEVH
Spanish Association of Vascular Nursing and Wounds
www.aeevh.es
CWA
Croatian Wound Association
www.huzr.hr
AFIScep.be
French Nurses’ Association in Stoma Therapy, Wound
Healing and Wounds
www.afiscep.be
DGfW
German Wound Healing Society
www.dgfw.de
AISLeC
DSFS
Italian Nurses’ Cutaneous Wounds A
­ ssociation
www.aislec.it
D A N I S H WO U N D
HEALING SOCIE T Y
Danish Wound Healing Society
www.saar.dk
AIUC
ELCOS
Italian Association for the study of Cutaneous Ulcers
www.aiuc.it
Portuguese Wound Society
www.sociedadeferidas.pt
AMP Romania
FWCS
Wound Management Association Romania
www.ampromania.ro
Finnish Wound Care Society
www.shhy.fi
APTFeridas
GAIF
AWTVNF
GNEAUPP
All Wales Tissue Viability Nurse Forum
www.welshwoundnetwork.org
National Advisory Group for the Study of P
­ ressure
Ulcers and Chronic Wounds
www.gneaupp.org
AWA
HSWH
Associated Group of Research in Wounds
www.gaif.net
Portuguese Association for the Treatment of Wounds
www.aptferidas.com
Hellenic Society of Wound Healing and Chronic Ulcers
www.hswh.gr
Austrian Wound Association
www.a-w-a.at
ICW
BEFEWO
Chronic Wounds Initiative
www.ic-wunden.de
Belgian Federation of Woundcare
www.befewo.org
LBAA
Latvian Wound Treating O
­ rganisation
BWA
Bulgarian Wound Association
www.woundbulgaria.org
LUF
The Leg Ulcer Forum
www.legulcerforum.org
CNC
Clinical Nursing Consulting – Wondzorg
www.wondzorg.be
LWMA
Lithuanian Wound Management Association
www.lzga.lt
SOBENFeE
Brazilian Wound M
­ anagement
­Association
www.sobenfee.org.br
International Partner Organisations
AAWC
Association for the Advancement
of Wound Care
www.aawconline.org
AWMA
Australian Wound Management Association
www.awma.com.au
CAWC
Canadian Association of Wound Care
www.cawc.net
Debra International
IWII
Int. Wound Infection Institute
www.woundinfection-institute.com
ILF
KWMS
Korean Wound Management Society
www.woundcare.or.kr/eng
NZWCS
EFORT
SILAUHE
CTRS
(Chinese Tissue Repair Society)
www.chinese-trs.com/en
110
World Alliance for Wound and
Lymphedema Care
www.wawlc.org
International Lymphoedema
­Framework
www.lympho.org
Dystrophic Epidermolysis Bullosa
Research Association
www.debra.org.uk
European Federation of National Associations of ­Orthopaedics and Traumatology
www.efort.org
WAWLC
New Zealand Wound Care Society
www.nzwcs.org.nz
Iberolatinoamerican Society of
Ulcers and Wounds
www.silauhe.org
SOBENFeE
Brazilian Wound M
­ anagement
­Association
www.sobenfee.org.br
Associated Organisations
Leg Club
Lindsay Leg Club Foundation
www.legclub.org
LSN
The Lymphoedema
Support Network
www.lymphoedema.org/lsn
EWMA Journal 2015 vol 15 no 1
Organisations
MASC
SSOOR
MSKT
SSPLR
MWMA
STW Belarus
Maltese Association of Skin and Wound Care
www.mwcf.madv.org.mt/
Hungarian Wound Care Society
www.euuzlet.hu/mskt/
Macedonian Wound Management Association
NATVNS
National Association of Tissue Viability Nurses, S
­ cotland
NIFS
Norwegian Wound Healing Association
www.nifs-saar.no
NOVW
Dutch Organisation of Wound Care Nurses
www.novw.org
PWMA
Polish Wound Management Association
www.ptlr.org.pl
SAfW
Swiss Association for Wound Care (German section)
www.safw.ch
SAfW
Swiss Association for Wound Care (French section)
www.safw-romande.ch
SAWMA
Serbian Advanced Wound Management Association
www.lecenjerana.com
SEBINKO
Hungarian Association for the Improvement in Care of
Chronic Wounds and Incontinentia
www.sebinko.hu
SEHER
The Spanish Society of Wounds
www.sociedadespanolaheridas.es
SFFPC
The French and Francophone Society
f Wounds and Wound Healing
www.sffpc.org
SSiS
Swedish Wound Care Nurses Association
www.sarsjukskoterskor.se
Slovak Wound Care Association
www.ssoor.sk
The Slovak Wound Healing Society
www.ssplr.sk/en
Society for the Treatment of Wounds
(Gomel, Belarus)
www.burnplast.gomel.by
SUMS
Icelandic Wound Healing S
­ ociety
www.sums.is
SWHS
Serbian Wound Healing Society
www.lecenjerana.com
SWHS
Swedish Wound Healing Society
www.sarlakning.se
TVS
Tissue Viability Society
www.tvs.org.uk
URuBiH
Association for Wound Management
of Bosnia and Herzegovina
www.urubih.ba
UWTO
Ukrainian Wound Treatment Organisation
www.uwto.org.ua
V&VN
Decubitus and Wound Consultants, N
­ etherlands
www.venvn.nl
WMAI
Wound Management A
­ ssociation of Ireland
www.wmai.ie
WMAK
Wound Management Association of Kosova
WMAS
Wound Management Association Slovenia
www.dors.si
WMAT
Wound Management A
­ ssociation Turkey
www.yaradernegi.net
Other Collaborators
DFSG
Diabetic Foot Study Group
www.dfsg.org
EADV
European Academy of Dermatology and Venereology
www.eadv.org
EPUAP
European Pressure Ulcer Advisory Panel
www.epuap.org
ETRS
European Tissue Repair Society
www.etrs.org
Eucomed
Eucomed Advanced Wound Care Sector Group
www.eucomed.org
EWMA Journal 2015 vol 15 no 1
Home Care Europe
ICC
International Compression Club
www.icc-compressionclub.com
MSF
Médecins Sans Frontières
www.msf.org
WUWHS
The World Union of Wound Healing Societies
www.wuwhs.org
For more information about
EWMA’s Cooperating Organisations
please visit www.ewma.org
111
6 Editorial
Science, Practice and Education
8 Efficacy of magnetic resonance imaging in deciding the appropriate
surgical margin in diabetic foot osteomyelitis. Fujii M, Armstrong DG,
Terashi H
15 Ex vivo platelet activation with extended duration pulse electric fields
for autologous platelet gel applications - A new, potential clinical
standard for platelet activation and perspectives for a more widespread
adoption and improved wound healing with platelet gels. Neculaes VB,
Torres A, Morton C, Larriera A, Klopman S, Conway K, Garner AL
21 Pressure ulcer reduction: the role of unregistered healthcare support
workers in validation and prevention. Ellis MB, Price J
27 Measuring change in limb volume to evaluate lymphoedema treatment
outcome. Williams AF, Whitaker J
Scientific Communication
35
42
47
54
61
65
71
Emerging targeted technology to address unmet clinical needs
- Implementing a development and adoption strategy. Vowden P
Great opportunities ahead! Don’t miss the boat! Where tech meets
health care. Reig J, Valverde JA, Reig M
A patient-led approach to product innovation in patient education and
wound management. McNichol E, McKay A, Milligan C, Bennett K,
Hulme R, Joy H
European perspectives on biomaterials for health. Donnelly F
An eLearning modular approach to pressure Ulcer prevention and
management: the views of nursing staff. Cameron R, Rodgers A, Welsh
L, McGown K
Major and minor amputation rates: What do they tell us?. Kröger K
Wound risk and prevention in obesity: The role of nutrition
Ballesteros-Pomar MD
Cochrane Reviews
77 Abstracts of recent cochrane reviews. Bell-Syer S
EWMA
84 EWMA Journal previous issues and other journals
86 EWMA 2015 Conference in London, UK, José Verdú Soriano
88 Promoting antimicrobial stewardship in wound care
91 eHealth in wound care - overview and key issues to consider
before implementation. Moore Z
93 EWMA news
97 Report from the 6th Pisa International Diabetic Foot Course 2014
Piaggesi A
98 The woundcare kit - a key tool for wound Care in a humanitarian
Environment. Vuagnat H, Comte E
100 Obituary notice
Organisations
101 AWMA news. Asimus M, Andrews J
102 AAWC news. Driver VR
103 Response to the challenges of chronic wound diseases: CTRS’s action
104 ELCOS - Portuguese Wound Society - an innovative approach
Furtado K, Santos T
106 Slovak Wound Healing Society (SSPLR). Koller J
108 Hellenic Society of Wound Healing (HSWH). Koulermou G
109 Conference calendar
110 Cooperating Organisations