Download A Case Study to Evaluate a New Soft Silicone Dressing, Mepilex Lite

Copyright B 2008 Wolters Kluwer Health | Lippincott Williams & Wilkins
Sheila K. MacBride, MN, BSc, PG Cert (TLHE),
RGN, NDN, Onc Cert
Mary E. Wells, MSc, BSc, RN
Carole Hornsby, BSc, DCRT
Lena Sharp, PhD, MSc, RN
Kristina Finnila, RN
Lynn Downie, BSc
A Case Study to Evaluate a New Soft
Silicone Dressing, Mepilex Lite, for
Patients With Radiation Skin Reactions
K E Y
W O R D S
Radiation skin reactions are a known side effect of radiation therapy. Moist
Cancer
desquamation reactions are not only painful but also may be a focus for infection
Radiotherapy
and can be dose limiting. There is a challenge to find a dressing which is protective,
Radiation skin reactions
comfortable, and atraumatic to delicate irradiated skin. The primary aim of this
Wound care
study was to evaluate patient comfort when using Mepilex Lite in the management
of dry and moist desquamation. Secondary objectives included safety, tolerance,
and influence on healing. Sixteen patients were recruited at 2 centers in the United
Kingdom and in Sweden when they had a RTOG score of 3 and 1 symptom measured
by the Radiation<Induced Skin Reaction Assessment tool. Digital photography was
used at each weekly visit. Patients completed the Radiation<Induced Skin Reaction
Assessment, daily diary cards, and open diaries for quantitative and qualitative
evaluation. Some patients found that the dressing minimized pain during dressing
changes and was easily lifted and adjusted without loss of adherent properties.
A new dressing had a soothing or cooling effect on the skin, and some reported a
more normal sleep pattern. The dressing had no negative effect on wound healing.
The researchers conclude that the dressing provides a promising alternative to
existing dressings and is worthy of further research.
adiation skin reactions are a known adverse effect of
radiation therapy affecting a large proportion of patients who receive radical treatment. Up to 95% of
patients receiving radiotherapy to the breast, groins, and perineum or head and neck region experience marked erythema,
R
which can feel extremely hot, tight, itchy, and uncomfortable.1
Up to a third develop moist desquamation reactions,2,3 which
not only are not painful but also provide an obvious focus for
infection and can sometimes lead to early cessation of treatment and therefore reduce the dose of radiotherapy delivered.
Authors’ Affiliations: School of Nursing and Midwifery, University of
Dundee, Dundee, Scotland, UK (Ms MacBride and Ms Wells); Ninewells
Hospital and Medical School, Dundee, Scotland, UK (Ms Hornsby and
Ms Downie); and Karolinska University Hospital, Huddinge, Stockholm, Sweden
(Dr Sharp and Ms Finnila).
Corresponding author: Sheila K. MacBride, MN, BSc, PG Cert (TLHE),
RGN, NDN, Onc Cert, University of Dundee, School of Nursing and
Midwifery, Fife Campus, Forth Avenue, Kirkcaldy, KY2 5YS, Scotland, UK
([email protected]).
Accepted for publication July 19, 2007.
E8 n Cancer NursingTM, Vol. 31, No. 1, 2008
MacBride et al
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Cancer nurses frequently struggle to find an appropriate
wound dressing that provides the protection required to enable
patients with severe skin reactions to continue radiotherapy in
comfort and also stays in place without causing further trauma.
Surveys of radiotherapy practice suggest that a wide variety of
wound dressings are used to manage radiation skin reactions
and that practice is most often dictated by local preference.4
Recent clinical guidelines advocate the use of dressings that
encourage moist wound healing,5Y7 but convincing evidence to
support the use of a particular type of dressing is still lacking.
Although there have been a number of studies evaluating skin
products designed to prevent and alleviate erythema, relatively
few have assessed the effects of wound dressings on established
and severe radiation skin reactions.8 Rarely have studies
considered patient comfort of primary importance.
An ideal wound dressing would alleviate symptoms, improve comfort, promote healing, and prevent further skin
damage from friction, trauma, or infection. In addition, such
a dressing could be left in place during radiotherapy or at
least removed for daily treatment without pain or trauma.
Because of the increased risk of skin reaction development
in skin-fold areas, the dressing would need to conform to
awkward areas and be able to retain its shape and position
without adhesive.
Soft silicone dressings are designed to cause minimal trauma
on removal and provide a moist wound healing environment
without the danger of maceration of surrounding skin. They
are already widely used in the treatment of burns9,10 and
other skin lesions.11 They have also been found to protect
irradiated skin without causing irritation.12 Mepilex Lite
(manufactured by Molnlycke Health Care) is a thin flexible
absorbent pad of polyurethane foam with an outer film of
polyurethane, which is vapor permeable and waterproof. The
backing film is coated with an acrylic adhesive whose function is to keep the dressing intact. The Safetac wound contact
layer attaches readily to the skin but can be removed easily
without causing damage to healthy tissue.
This study was designed to evaluate the comfort and
overall experience of using Mepilex Lite in the management
of brisk erythema or moist desquamation during radiotherapy
treatment. The study was initiated and commercially sponsored by the manufacturer. The study plan was developed by
the commissioned researchers.
(Karolinska University Hospital, Huddinge). Each center was
allocated a convenience quota sample of 10 patients. Ethical
approval was sought and obtained in both centers. Eligibility
criteria are listed in Table 1.
In both centers, a senior radiographer (CH) or nurse/
radiographer (LS, KF) was responsible for assessing eligibility.
The Radiation-Induced Skin Reaction Assessment Scale
(RISRAS)13Y15 was used to screen patients for entry into the
study (see Figure 1). Patients undergoing radiotherapy to the
head and neck or breast were recruited if they were experiencing severe erythema and/or moist desquamation along
with at least 1 symptom (see Figure 1).
Following informed consent, baseline demographic and
treatment data were collected including age, sex, medical
history, medical treatment, and cancer diagnosis. Digital
photographs of the radiation skin reaction were taken, and
patients were asked to assess their own symptoms using the
self-report scale on the RISRAS. Patients were given a supply
of appropriately sized dressings and some Mepitac soft
silicone tape to be used if dressings needed additional fixation.
Patients were encouraged to wash their skin gently each day
with a mild soap and were shown how to apply the dressings
to the affected area with the use of a mirror as necessary.
Dressing changes were performed according to usual hospital
routines, by nurses in clinic or by patients themselves.
Dressings were to be used until the skin reaction had healed
or for a maximum of 4 weeks after the patient received their
last fraction of radiotherapy. All patients who participated in
the study were to be followed for at least 15 dressing changes,
unless healing took place sooner. Patients were assessed weekly
using the RISRAS while on treatment and were asked to
return to the treatment center each week after completion of
treatment. Each day, patients recorded the number of dressing
changes and size of dressings used; the extent to which they
were troubled by pain, itching, burning, and sleep disturbance; and the level of comfort they experienced while
wearing and removing the dressing on a symptom diary card.
Patients were also given an open, unstructured diary in
which they were asked to write about the impact of their skin
reaction and any experiences of using the dressing. The
radiographers/nurses responsible for assessing patients also
Table 1 & Inclusion and Exclusion Criteria
Inclusion Criteria
n
Aim of Study
The primary aim of the study was to evaluate patient’s comfort with using Mepilex Lite. Secondary objectives included
safety, tolerance, and influence on healing.
n
Methods
This series of case studies took place in 2 sites. Patients were
recruited from 1 of 2 radiotherapy departments in Scotland
(Ninewells Hospital and Medical School) and Sweden
Mepilex Lite for Patients With Radiation Skin Reactions
Exclusion Criteria
& Diagnosis of breast or head
and neck cancer
& Prescribed radical radiotherapy
& Male or female
& 18 years and older
& Erythema Q 3 and/or moist
desquamation 9 0 followed
by at least 1 symptom Q 1
according to the RadiationInduced Skin Reaction
Assessment Scale
& Written consent
& Allergy/hypersensitivity
to any of the components
in the dressing
& Assessed as needing a
highly absorbent dressing
& Clinical staff considered
that they would have
problems complying
with the protocol
& Patients previously
included in the
investigation
Cancer NursingTM, Vol. 31, No. 1, 2008
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n
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Figure 1 n The Radiation-Induced Skin-Reaction-Assessment-Scale (RISRAS) modified Patient Symptom Scale.
recorded their perceptions of the dressings in the Case Record
Form. Digital photographs were taken each week, and any
adverse events or changes in dressing use were documented.
RISRAS symptom and appearance scores for each patient
were added to form a total score, which was plotted on an
EXCEL graph. Scores for diary symptoms and dressing
changes were analyzed descriptively. Photographs were
reviewed to document changes in skin reactions and assess
the pattern in which dressings were applied.
n
Results
Two patients were withdrawn from the study because they
experienced increased itching after the dressing was applied
and a reduction in symptoms when it was removed. These
patients were documented as having experienced an adverse
device event, thought to be due to individual sensitivity to the
dressing. Three further patients discontinued the use of the
dressing before the end point had been reached, choosing to
use an alternative dressing. Patients often chose to apply the
dressings in an individual manner that best suited their needs;
for example, most patients used several smaller dressings to
allow flexible movement and minimal tension rather than
applying 1 larger dressing to the whole area (see Figure 2A).
Patient Characteristics and Sample
Symptoms Measured by the RISRAS
Patients were recruited from both centers during November and
December 2003 and January 2004. Center 1 recruited 5 patients,
and Center 2 recruited 11 patients (see Table 2). All were white.
Figure 3 shows the RISRAS scores of the 11 patients who
used the dressings for at least 15 dressing changes, or until
healing had occurred.
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MacBride et al
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Table 2 & Patient Recruitment
a
Patients 102, 208, and 209 were dropouts. However, patients 102 and 208
still fulfilled the criteria for being evaluable patients.
As seen in Figure 4, overall patients experienced consistent
improvement in all aspects of their skin reaction after applying the dressing. Some patients (see Figure 2B) demonstrated
improved symptoms and even a decrease in their objective
skin score after using Mepilex Lite, despite the fact that they
had not completed their radiotherapy treatment. Comments
from the radiographer/nurses showed that improvements in
patients’ skin condition had been faster than expected.
Patient Diary Cards
The diary cards provided information on the subjects’ perception of comfort when wearing and removing the dressings
(see Figure 3a and 3b). The average comfort score for the 15
evaluable patients who completed this question on the diary
card was 2 (quite a bit). The average comfort score upon
removing the dressing for the 11 evaluable patients who
completed this question was 2.4 (2 = quite a bit and 3 =
very much).
Open Diaries
The open diaries were intended to offer a view of the impact
of the radiation skin reaction and the application of the dressings on quality of life. Four Swedish and 5 British patients
completed diaries, and these were translated into English and
reviewed by one of the investigators (SKM). Comments were
analyzed for positive or negative orientation.
Positive responses included the benefits of the dressing in
terms of reducing friction from clothes, bedclothes, and car
seat belts; the difference made by the dressings on comfort
and activities of daily living; the dressing staying in place and
relieving pain (eg, ‘‘And thanks to the dressing, my blouse
doesn’t rub against the scar on my chest’’ [patient 204/day 2]).
Many commented on the best way to use the dressings for
comfort and ease of movement in activities of daily living
(eg, ‘‘I don’t feel so tired today as there was not so much
painVthe pain even over the 2 or 3 days before using the
dressing, had been very wearing and tiring’’ [patient 104/day 2]).
Indeed the focus of comments was predominantly the benefit
Mepilex Lite for Patients With Radiation Skin Reactions
of the dressings in promoting activities of daily living such as
exercise and sleep (eg, ‘‘First night, big difference, did not
wake from any pain’’ [patient 208/day 1]).
Negative comments mainly focussed on the difficulties of
managing very moist wounds, where the dressing did not
always remain comfortable or stay in place. Some patients
also commented that the dressing seemed to remove a
superficial layer of skin and were understandably concerned
about this, (eg, ‘‘Skin coming away with dressing, but no pain
with it’’ (104/day 6)].
There were some more detailed commentaries on patients’
experiences of moist desquamation. Some differences were
found between the UK and Swedish responses. Four Swedish
patients completing diaries described dealing with the experience in a daily time frame and the relief of being able to manage the skin reaction using dressings. UK patients described
the dressing and its contribution to their quality of life, the
experience of moist desquamation, and the significance of the
radiographer and clinical nurse specialist as a support in the
experience (eg, ‘‘The only reason I changed the dressing twice
in the last 24 hours was a personal rather than a medical one.
It was my son’s 21st birthday party and as it was going to be
an effort for me due to fatigue from the radiotherapy, I
wanted to be sure that I felt as comfortable as possible’’
[patient 104/day 4]).
Not all patients completed the open diaries, and the
analysis of positive and negative comments is clearly limited
in scope. However, the detailed insights gained do suggest that
open diaries may be a useful means of determining the impact
of radiation skin reactions on individuals’ quality of lifeVan
aspect of research that is largely absent in the literature.
n
Discussion
The optimal management of radiation skin reactions remains
a daily challenge for healthcare professionals. Surveys conducted in the last 10 years show that practice is inconsistent
and controversies about the most appropriate wound management technique still exist. Recent guidelines5Y7 advocate moist
wound healing methods for moderate to severe radiation skin
reactions, but evidence to support such advice is limited. A
wide variety of dressings have been evaluated,8 and many
studies do support the use of hydrogels, hydrocolloids, or
films to alleviate discomfort and promote healing, but this is
not exclusively the case. Mak et al16 found no significant
differences in healing between patients using hydrocolloids
and those using gentian violet; although comfort and aesthetic
appearance were superior in the hydrocolloid group, wound
size was greater, and there was a trend toward higher pain
severity. A recent randomized trial3,17 also suggests that we
may need to reconsider the place of simple protective dressings and consistent skin hygiene in maintaining skin integrity
during radiotherapy. Porock and Kristjanson18 concluded
that the choice of topical product should be based on patient
preference and comfort, and the conflicting evidence we have
to date adds weight to this argument.
Cancer NursingTM, Vol. 31, No. 1, 2008
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n
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Figure 2 n (A), Patient 103. This was a 41-year-old lady who had wide local excision of the breast after a diagnosis of breast
cancer. The subject was recruited to the study when she had received her 45-Gy prescribed dose of radiotherapy to the breast and
surrounding tissue. She continued treatment and received a further 16 Gy in 8 fractions to a field 8 8 cm to the scar area. Aqueous
cream had been prescribed for application to the skin within the treatment field. The photographs show the patients’ skin at
recruitment, 1 week later, and 2 weeks later at final visit. The RISRAS shows that despite persistent moist desquamation, pain and itch
were reduced by the application of the dressing. This patient rated the dressing overall as ‘‘very good.’’ She used the dressings in
a patchwork pattern to allow easy movement. Her diary comments that she found the dressing simple to apply and exceptionally
comfortable. She also notes immediate relief of symptoms when the dressing was applied, friction from clothing was reduced, and a
better sleep gained. (B), Patient 211. This 54-year-old gentleman at the Swedish center was recruited when he had received 62 Gy
from 64-Gy prescription to the head and neck region for laryngeal cancer after laryngectomy. Propyless lotion had been applied
to the skin reaction when erythema developed. Grade 3 skin reaction therefore occurred during his radiotherapy. The photograph
displays the extent of the skin reaction at recruitment. The RISRAS graph illustrates a faster skin healing time than might otherwise
have been expected for someone with this dose to this region of the body. The dressings were cut to fit his stoma. He rated the
dressing as very good overall and also found conformability of the dressing to be good. In his diary, he noted that application of the
dressing reduced pain and tightness associated with his skin reaction.
E12 n Cancer NursingTM, Vol. 31, No. 1, 2008
MacBride et al
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Figure 3 n A. Center 01. Question 5: How comfortable was the
dressing when it was in place? B. Center 01. Question 6: How
comfortable was the dressing to remove?
The primary aim of this case study was to evaluate comfort
with Mepilex Lite. Our results suggest that most patients
found the dressing comfortable to wear and to remove. In
many cases, it had a considerable (and sometimes immediate)
impact on activities of daily living, including sleeping, wearing clothes, and using a car seat belt. A few patients did experience sensitivity to the dressing, and it is of some concern that
2 patients had to stop using Mepilex Lite because of severe
itching (an adverse device event that had not been previously
noted by the manufacturers in previous studies). One patient
also found that the dressing was inadequate for the amount
of exudate produced by her radiation reaction. These findings
suggest that it may be appropriate to ‘‘patch test’’ the dressing
before applying it over a large area, and that highly exuding
wounds may require a more absorbent dressing such as Mepilex
or an alginate or foam.
Given that most radiotherapy treatment is delivered on an
outpatient basis and developments in care delivery require
patients to assume greater responsibility for self-care, it is important that dressings can be managed by patients themselves.
Our experience suggests that patients in this study were able
to apply, change, and adapt dressings to suit their needs, and
indeed several patients cut the dressings to shape or used
dressings in a ‘‘patchwork’’ pattern to cover affected areas and
alleviate discomfort (see Figure 4). Those with large areas of
moist desquamation found it more comfortable to use a combination of small dressings rather than one large one, commenting that they felt less tension on their skin. Dressings
sometimes curled up or wrinkled in awkward areas such as
skin folds, but Mepitac tape was used very successfully to
overcome this problem. Some patients suggested that it would
be useful to have a template to follow, and it may be that
individual templates could be suggested by nurses or radiographers overseeing the patients care.
Mepilex Lite for Patients With Radiation Skin Reactions
Experienced nurses and radiographers monitoring the use
of Mepilex Lite were very positive in their evaluation of the
dressings. Their comments largely supported those of patients,
agreeing that the dressings were very successful for patients
with erythematous and slightly moist skin reactions but were
less effective in patients whose reactions were producing large
amounts of exudate.
The generalizability of this study’s findings is limited by
the small number of patients and the fact that there is no
control group. However, case studies using multiple methods
are useful for the specific descriptive information they provide
about individual cases. They can make a significant contribution to theory and practice through ‘‘force of example.’’19
The generalizability of case studies should therefore be judged
in terms of the relevance of findings to others, rather than by
the statistical generalization of findings to populations.20
We did not attempt to standardize the variable of radiation dose because the aim of the study was to evaluate the
comfort and overall experience of using Mepilex Lite in a
selection of typical patients undergoing radiotherapy, rather
than to draw any specific conclusions about skin reaction
development and healing in relation to dose. However, future
studies should include larger numbers of patients, with
suitable control groups that take account of variables such
as radiotherapy dose and other known risk factors.3
It should be noted that only patients with head and neck
or breast cancer were included in this study and that those
with mild radiation skin reactions or skin reactions requiring
a highly absorbent dressing were excluded. The results of this
study suggest that Mepilex Lite is worthy of further investigation in patients who are receiving radiotherapy treatment
to other sites associated with radiation skin reactions such as
the pelvis. However, we believe that we have established proof
of principle, that Mepilex Lite provides a safe and attractive
alternative to existing dressings and that it provides particular
protection and comfort.
n
Conclusions
This small case study suggests that Mepilex Lite promotes
comfort in patients with brisk erythema or moist desquamation and that it is safe and well tolerated by patients undergoing
radiotherapy treatment. The fact that 2 patients had to stop
Figure 4 n RISRAS scores for all subjects in the study.
Cancer NursingTM, Vol. 31, No. 1, 2008
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n
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using the dressing due to itching is of some concern, but this
contradicts previous research using this and other silicone
dressings. Because itching is a feature of the symptom
experience, this may be coincidental and further trials should
consider testing for silicone sensitivity. Mepilex Lite seems to
promote healing and may be left in place during treatment.
Mepilex Lite offers a real alternative to current treatments
in use for severe erythema and moist desquamation and has
many important advantages in terms of comfort, ease of
removal, skin protection, and quality of life.
7.
8.
9.
10.
ACKNOWLEDGMENTS
11.
We would like to acknowledge the genuine support and
encouragement from the members of the team at Molnlycke
Healthcare, in particular, Bengt, Annelie, and Jens.
12.
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MacBride et al
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