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Impact of Microscopic Foreign Debris on Post-Surgical Complications
TRUSCOTT
Impact of Microscopic Foreign
Debris on Post-Surgical
Complications
WAVA TRUSCOTT, PH.D.
DIRECTOR, SCIENTIFIC AFFAIRS & CLINICAL EDUCATION
KIMBERLY-CLARK HEALTH CARE
ROSWELL, GEORGIA
ABSTRACT
M
inute pieces of debris left in the surgical site can interfere with optimal wound healing. Even when
these microbodies are not obvious without magnification, their presence can cause post-surgical
complications including infections, amplified and prolonged inflammation, permanent tissue dam-
age, exaggerated and reduced quality scarring, granulomas, adhesions, organ dysfunction, infertility, and
other pathological consequences. This chapter reviews foreign debris-initiated, post-surgical complications;
presents associated pathological mechanisms; identifies sources of debris contamination; describes foreignmicrobody characteristics that can further amplify pathological responses; and presents recommendations
for minimizing their presence.
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SURGICAL TECHNOLOGY INTERNATIONAL XII
INTRODUCTION
One of the most important attributes of living organisms is the capacity to
self-repair. This ability is expected and
observed every time a major or minor
invasive procedure is performed on a
patient. Needless to say, lack of this
healing ability would render surgery
useless. Every injury, whether a broken
leg, bloody nose, or paper cut, would
be a potential death sentence. If the
body's healing systems were present but
only minimally effective, one might
make it through childhood spills, preadolescent tumbles, and sports warrior
clashes alive, but seriously scarred, misshapen, and minimally functional.
Instead, a surgeon removes an
appendix, sets crushed legs, and performs brain surgery assuming (or at
least, expecting) normal wound-healing
repair will occur in an automatic
sequence within a fairly predictable
time period. Simplistically, all that is
necessary is to make sure the parts are
kept moist and clean, properly aligned,
and adequately bound. Although the
auto-pilot repair process initiates to
some degree in any individual, the quality of repair can vary substantially
depending on the condition of the
patient's general health and well being,
degree of trauma, oxygen tension in the
affected tissues, presence of foreign
microbodies, level of microbial contamination, local temperature, etc.
Suboptimal conditions can delay or
interrupt the auto-processing sequence
of repair which produces anomalies
ranging from dehiscence to excessive
scarring; positioning slip to severe adhesions; discreet granulomas to purulent
discharge; and internal intact abscesses
to ulcerous, open lesions. As our understanding of the "ideal environment"
expands, so does the list of procedural
directives. One area that has had considerable focus in some specialty procedures, but is often neglected in others,
is the impact of foreign microbody contamination on post-surgical complications.
contributing to post-surgical complications are shown in Table I. The consequences of surgical-site contamination
with these microbodies can differ significantly depending on the specific characteristics of the individual particles.
These are discussed later in this chapter.
Major post-surgical consequences of
foreign microbodies include infections,
amplified and prolonged inflammation,
granulomas, and adhesions. An understanding of the pathology created by
foreign bodies that lead to such complications is helpful in determining the
way in which these consequences interact. However, foreign microbodies have
been identified as causative or contributing agents of patient complications
consequential to a much wider range of
pathological mechanisms (Table II).
FOREIGN-BODY-ASSOCIATED INFECTIONS
Foreign-body-associated infections
have been reported extensively in the
literature. Infections following the
implantation of catheters, open drains,
vascular grafts, heart valves, and prosthetic materials are very familiar. When
a staphylococcal abscess is discovered on
a synthetic vascular graft months after
Particulates
Table I
Foreign Microbodies
Lint/fibers
Glove cornstarch powder
Sutures
Bone fragments
Degraded/worn implants
Burned tissue
Hair
surgery, little doubt exists that the etiology was a foreign-body-associated infection.
However, the cause-and-effect relationship is less obvious when the foreign
materials are too small to be readily visible. At the foci of a nodular abscess,
there may be a piece of suture; lint
(fibers) from drapes, gowns, caps, lap
sponges; or powder particles from surgical gloves. Seldom do surgical-site
infections involve histopathological
investigations beyond identification of
the infective microorganism and its
antimicrobial susceptibility. Foreign
microbodies distract and occupy the
attention of the local immune defenses,
which allow otherwise harmless levels
of microbial contamination to multiply
unimpeded. The few incidental tran-
Pseudomonas
FOREIGN MICROBODIES
Foreign microbodies or debris that
can be deposited in the surgical wound
are extremely diverse. Those which
have been identified most frequently as
Macrophage
Figure 1. The attention of this macrophage has been occupied in consuming foreign microbodies.
Pseudomonas positioned near the macrophage have multiplied unimpeded, establishing a local infection.
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Impact of Microscopic Foreign Debris on Post-Surgical Complications
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Table II
Adverse Consequences of
Foreign Microbodies
Complications Reported
Intestinal obstruction
Infertility
Toxic lens syndrome
Loss of visual acuity
Stroke
Phlebitis
Kidney loss
Implant rejection
Seizures
Misdiagnosis as disseminated
carcinoma
Death
Pathology
Amplified and prolonged
inflammation
Delayed healing
Reduced local resistance to
infection
Granuloma formation
Thrombus formation
Adhesion formation
Ischemic tissue death
Pain
Excessive scarring
Poor scar strength
Sterile purulent discharge or
abscess
sients, which would normally have been
phagocytized and destroyed, are
allowed to rapidly become an infection
(Fig. 1).
These observations have been noted
experimentally by Elek and Conen1 and
Noble 2 who demonstrated in classic
suture abscess models that an initial
inoculum of 100 (102) colony forming
units (CFU) of Staphylococcus aureus
would cause an infection. Without the
suture fragment, an inoculum of
10,000,000 (107) CFU injected subcutaneously was incapable of producing an
infection. 3 In addition, Edlich et al.
determined that some sutures are more
potent adjuvants of bacterial proliferation than others. 4,5 The effect of the
suture fragment on the local tissue
defenses depends on the configuration
(braided or monofilament), chemical
composition (Table III), diameter, and
length of the fragment.
Jaffray et al. demonstrated a similar
decrease in the level of inoculum needed to initiate an infection using cornstarch powder instead of suture
fragments. In this study, 1 of 10 wounds
became infected when 1000 (103) CFU
of Staphylococcus aureus was present
without foreign debris. When 2 mg of
sterile glove cornstarch powder were
also placed in the wounds, a sustained
infection was observed in 9 of the 10
wounds.6 When considering that a pair
of sterile powdered surgical gloves can
easily have 300 mg of powder,7 2 mg is
quite low. In a more recent study, Ruhl
et al. also confirmed that glove powder
significantly reduces the local resistance
to infection.8
Zimmerli et al., and more recently
Renz and Gemsa, experimentally elucidated the mechanisms by which the efficacy of the local immune system is
diminished in the presence of foreign
debris.3,9 Using Teflon fibers, Zimmerli
et al. demonstrated that when polymorphonuclear leukocytes (PMNs) come in
contact with foreign debris that is too
large to be phagocytized, they expel
Table III
Infection Potentiating Effects of Surgical Sutures
Potentiating Capacity
Absorbable
Non-Absorbable
Least
to
Highest
Synthetic
Plain gut
Chromic gut
Nylon (polypropylene)
Dacron
Metal
Silk
Adapted from Edlich RF, Rodeheaver GT, Thacker JG. Chapter 35: Surgical
Devices in Wound Healing Management. In: Cohen IK, Diegelmann RF, Lindblad
WJ (eds), Wound healing: biochemical & clinical aspects. Philadelphia: WB
Saunders Company, p 594, 1992.
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myeloperoxidase in the direction of the
microbodies attempting to kill the perceived threat. This threat leaves local
PMNs with diminished phagocytic capability, reduced granule content, and
diminished capacity to mount a respiratory burst.3 As PMNs are the first line
of defense, the burden of protection in
the tissues is then shifted to the
macrophage.
Renz and Gemsa performed in vitro
macrophage experiments using powder
rinsed from sterile surgical gloves.
Between 100 and 300 million particles
were collected from each glove. Challenge suspensions were diluted to
deliver two powder par ticles per
macrophage.9 The powder microbodies
initiated the release of large amounts of
tumor necrosis factor (TNF), interleukin 1, prostaglandin E2, thromboxane B 2 , and hydrogen peroxide.
Interleukin 1 is an important mediator
of the inflammatory response that acts
as a co-stimulatory factor for T-cell activation and mediator release. TNF is also
a potent stimulator of the inflammatory
response that causes vasodilation and
redirects additional inflammatory cells
to the local area. The prostaglandin
products also play a major role in the
inflammatory activity by inducing pain,
vasodilation, cell redirection, up-regulations of adhesion molecules, and activation of endothelial cells.9-11
Release of these inflammatory mediators is associated with increased
macrophage death, confirmed by quantitative measurement of lactate dehydrogenase (LDH)–an enzyme released
by a macrophage when it dies (apoptosis). The dying macrophage releases the
fully or partially ingested foreign microbodies. Additional macrophage cells
that have been redirected to the area
then attach to these released particles,
resulting in further heightened inflammation and repeatedly thwarted defenses.
Whether the foreign microbodies are
powder particles, suture fragments, or
lint fibers, the micro-environmental
conditions altered by release of these
toxic moieties and hydrolytic enzymes
initiate local hypoxia,12 acidosis, and fibrin deposition.13 The oxygen tension in
a foreign-debris-contaminated wound
has been measured in the 20 mmHg
range compared to healed wound tissue
values of approximately 40 mmHg. This
reduced available oxygen fur ther
inhibits microbicidal capability. The
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Surgical Overview
SURGICAL TECHNOLOGY INTERNATIONAL XII
increased fibrin deposition sequesters
and protects multiplying microorganisms, which allows them to strengthen
their foothold in the tissue14 until, finally, a local infection is established (see
Fig. 1). Thus, the presence of foreign
microbodies in the surgical site increases the risk of post-surgical infection
both by thwarting the efficacy of leukocyte defenses and altering the local tissue environment, making it more
favorable for microbial growth.
A purulent discharge, or pus-filled
abscess, may or may not be positive for
microbial growth. The absence of
microbial confirmation is not uncommon. The perpetuating cycle of leukocyte recruitment and death produces
pus as the dead white cells fall into the
increasing serous fluids of the escalating
inflammatory response even without
microbial contamination. In some situations, the purulent discharge may be
sufficient to require drainage in order to
prevent pressure damage to more delicate structures. A foreign microbody or
debris reaction should be considered
when sterile pus continues to be present.
It is important to emphasize here
that microbodies–including powder15
and lint16-18–may carry microorganisms.
Whether the microorganisms come
from the environment [inside or outside
of the Operating Room (OR)], staff
members, or the patient, they can
attach to microbodies and be dispersed
into the air and/or deposited onto
instruments and directly or indirectly
into surgical wounds. In the wound,
these microbial-laden microbodies
deliver both the inoculum and "defense
interference" to the surgically traumatized host, which establish all the components necessary for an opportunistic
infection.
Cost
Nosocomial infections are expensive.
Surgical-site infections develop in 2%5% of the 50 million U.S. surgical
patients per year, which increases their
hospital stay by an average of 7.4 days.
The increased U.S. annual hospital costs
attributed to surgical-site infections is
estimated to be $130-$845 million
per year. Wong estimates total costs
including indirect expenses related
to surgical-site infections may exceed
$10 billion annually.19
Abscesses (lint): Two patients
developed cellulose fiber-initiated
Figure 2. Contamination of a surgical wound with foreign debris can interfere with normal healing. The
inflammatory presence of microbodies can produce "sterile" pus containing dead neutrophils,
macrophages and granulomatous suspensions. This presence of microbodies also increases the risk of
infection. Photograph provided by Medical-On-Line Ltd.
intra-abdominal abscesses. Lint captured while handling cellulose-based
disposable gowns and drapes used in
the OR were identical to those in
the granulomas.20
Sterile pus and seizures (powder): After meningioma removal, a
42-year-old female experienced
focal fits and a grand mal seizure.
After 10 days, evidence of intracra-
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nial shift of midline structures
necessitated re-surgery. No hematoma or other obvious cause for her
difficult recovery was noted. She
improved until 14 days after the second craniotomy when the wound
became painful and copious quantities of sterile pus were discharged.
Histopathological examination of
the wound tissues revealed glove-
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Impact of Microscopic Foreign Debris on Post-Surgical Complications
TRUSCOTT
Figure 3A. Shows a 2-cell embryo where the growth media came in contact
with gloves compatible with the embryo.
Figure 3B. Illustrates contact with sterile gloves containing embryotoxic
chemicals.
Figure 3C. Shows the same contact of the growth media on fibroblasts with a
biocompatible glove.
Figure 3D. Illustrates contact with a glove that contains cytotoxic chemicals.
Figure 3. The physical presence of foreign debris in a surgical wound heightens the inflammatory response by its presence. The biological response may be
increased when cytotoxic chemicals, chemical sensitizers or endotoxin is carried on the particle.
powder granulomas. A third craniotomy was performed, and
unhealthy granulation tissue was
removed–this time without powder
contamination of the site. Recovery
was excellent. The total hospital
stay from the date of the first procedure was two months.21
AMPLIFIED AND PROLONGED
INFLAMMATION
As discussed, the frustrated defensive
activities of PMNs and macrophages
serve to amplify the local inflammatory
response above that needed to initiate
normal tissue repair secondary to any
invasive procedure. Once the PMNs
exhaust their attack efforts and the
macrophages infiltrate the site (9-48
hours), their activities continue to
heighten as more and more of these
cells expend their efforts and die. Each
phase of leukocyte activity not only adds
to the tissue damage, but also continues
to create "dead cell debris," which further escalates the inflammation and
increases leukocyte infiltration. Collateral damage inflicted on healthy tissues
by the frustrated white cells perpetuates
the inflammatory response through a
variety of mechanisms including the
activation of kinin, coagulation and
complement cascades, as well as deposition of fibrin.10
Symptomology depends on the level
and characteristics of foreign-debris
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contamination, location of the surgical
site, and the patient's physiological
makeup and treatment regimen. If the
level of debris contamination is significant and the surgical site is in the
abdominal region, the large volume of
fluid access allows for significant amplification of inflammatory swelling. Several liters of extravascular serous fluids
have been drawn from foreign-bodyinduced peritonitis.22 Furthermore, the
level of swelling can be sufficient to
cause dehiscence of the healing wound
(Fig. 2).
If the foreign debris is such that it
eventually dissolves, or is broken down
and removed by the immune system,
the amplified inflammatory response
may resolve after a prolonged recovery.
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SURGICAL TECHNOLOGY INTERNATIONAL XII
Figure 4. Giant cells with peripheral nuclei are indicative of an immunological reaction (as in Type IV,
delayed hypersensitivity to the foreign microbody). Nuclei dispersed throughout the giant cells in this
forming granuloma are indicative of a foreign body reaction.
The patient may have been subjected to
additional swelling, pain, fever, malaise,
nausea, wound-care activity, or experienced some exaggerated scarring, but
recovered. Alternatively, if the foreign
debris continues to resist effective dissolution and continues to aggravate
immune responses, the inflammatory
process will progress to chronic status.
Lymphocytes, plasma cells, mast cells,
and eosinophils are usually involved in
this more persistent inflammatory state.
The various cytokines and mediators
they release keep the process recycling
if the debris remains. If the reparations
at the incision site continue to hold, fibrin is deposited while local tissues continue to swell, which necessitates the
spanning of larger spaces with a more
extensive fibrin volume. Normal fibri-
nolytic activity has been shown to be
hindered by the presence of some types
of debris. When the self-destruct fibrinolytic activity is only partially active,
the residual fibrin is overlaid with collagen and the scar becomes hypertrophic.
It is interesting to note that such scars
often have less tensile strength and elasticity on hypertrophic scars formed
subsequent to glove-starch contamination, as noted in studies performed by
Corless et al. (see Fig. 2).23
Inflammation is a potentiator and
consequence of cell injury. If fibroblasts
are the target, the result is amplified
inflammation. If the injury is to specific
specialized cells, the consequences are
more specific, such as when foreign
debris contributes to complications
after ophthalmic surgery, in vitro fertil-
Figure 5A. Foreign microbody-associated granuloma with consequential
inflammatory response. Photograph provided by Mediscan
ization (IVF) procedures (Fig. 3), etc.
Excessive scarring (fibers): A
54-year-old diabetic underwent radical mastectomy. Considerable pain,
serous drainage, and general inflammation were noted. Wound edges
remained erythematous and healing
was slow. Four months later, the
hard, irregular, unattractive scar
was excised. Resurgery and 10
extra days of hospitalization were
required. Early aesthetic healing
ensued. Histology of specimen
revealed cellulose fiber granuloma
(one fiber, not a plethora of
debris).24
Opthalmic
complications
(fibers/powder): The Journal of
Refractive Surgery reported 100+
cases of diffuse lamellar keratitis
following LASIK surgery until environmental particulate contamination was identified and resolved.25
Foreign microbodies have also been
a contributing factor in the etiology
of sterile endophthalmitis,26,27 toxic
lens synd-rome,26 occular fibrosis,27
recurrent uveitis,26 and severe ocular inflammation28 (particulate dose
dependent), resulting in diminished
visual acuity.
IVF failure (powder): In vitro
fertilization labs have experienced
embryotoxic episodes associated
with powder from powdered
gloves.29 The actual toxicity may be
associated more appropriately with
the glove chemicals absorbed by the
powder, as studies have shown that
glove chemicals can be cytotoxic
depending on the type and amount
of chemical used in production.30
Figure 5B. Suture fragment granuloma. Photograph provided by Mediscan
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Figure 6. Adhesions around fallopian tubes or between fimbrae are a significant cause of infertility. The
likelihood of adhesion-induced infertility increases with the number of abdominal or thoracic procedures.
Adhesions are responsible for over 40% of intestinal obstructions and 60%-70% of small bowel obstructions. Photograph provided by Mediscan
GRANULOMA FORMATION
After continued, frustrated efforts to
rid the area of foreign debris,
macrophages attempt to increase their
defensive capability by aggregating
together to transform epithelial-like
cells referred to as "epithelioid cells".
Frequently, but not always, the cell
membranes between these epithelioid
cells can fuse together to form giant
cells in the periphery or center of granulomas. The mass of these giant cells
usually ranges between 40-50 µm and
has 20 or more nuclei. Nuclei that are
scattered in the fused cytoplasm of the
giant cell are indicative of a chronic
inflammatory response to a foreign
body. When the nuclei are positioned
along the periphery of the giant cells
(Langerhans-type giant cells), they suggest a delayed hypersensitivity (Type IV)
reaction to the foreign debris (Fig. 4).
The epithelioid cells, or giant cells,
are then surrounded with mononuclear
leukocytes, primarily lymphocytes with
occasional plasma cells. This enclosed
entity is the granuloma (Fig. 5). If the
foreign debris continues to resist dissolution, a coating of fibroblasts and connective tissue will enclose the mass
creating larger, more distinct nodules. If
the encased particle is capable of inducing a cell-mediated response (Type IV
Delayed Hypersensitivity), and the
patient has been previously sensitized,
the granulomatous activity and inflammatory response will be significantly
more profound. What would have been
a papule formation in an allergic contact
dermatitis is expressed as a granuloma
in the interior of the wound. In the
early stages of the immunologic
response, the attacking macrophage
ingests a piece of the foreign debris and
presents to appropriate T-lymphocytes,
which causes them to activate. In so
doing, the T-cell produces and releases
cytokines that activate other T-cells and
more macrophages, exacerbating and
perpetuating the response.
It is possible that persons genetically
capable of developing a Type IV hypersensitivity to a particular chemical on
(or within) the pieces of foreign debris,
have not yet been sufficiently exposed
to have reached their individual threshold for symptom expression to that particular antigen. However, the slow
leaching of an antigen from a particle
being gradually dissolved may be sufficient to initiate a delayed hypersensitivity reaction later in the post-surgical
recovery period. The delay in reaction
makes the temporal connection to the
surgical procedure more of a challenge.
Other foreign-microbody-initiated
"clumps" are generated by alternative
mechanisms. Foreign microbodies may
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be deposited within the circulatory system during procedures such as vascular
or cardiac repair, cardiac catheterization, or when establishing a central
venous line where they can attract
platelets and initiate coagulation. Additionally, particles can injure vessel walls
triggering the coagulation cascade. The
microbodies become wrapped in
platelets and leukocytes forming clots,
potentially the cause of post-surgical
complications that involve both morbidity and mortality.31
If the particle surface texture is sufficiently abrasive, the composition is
toxic, or the particle is contaminated
with endotoxin, complement is also
activated. Injury to the vascular lining
may then spread beyond the immediate
point of particle entry, which increases
the area impacted by inflammation. Particulate contamination of the circulatory
system has been associated with morbidity including strokes, cardiac infarction, local and remote tissue ischemic
damage, deep vein thrombosis and
phlebitis, as well as mortality.
Infant
bilateral scrotal masses
(powder): Surgery was performed
on a 2-month-old male infant with
bilateral scrotal masses resulting
from foreign-body reactions to
glove powder. A pyloromyotomy
was performed in the neonatal period. Later, the powder particles
migrated from the surgical site to
the scrotum.32
Fatal embolism (suture): Following mitral valve replacement
surgery, a suture fragment escaped
detection and fell into the circulatory system. A thrombus formed
rapidly around the suture, which
subsequently lodged in the left anterior descending coronary artery.33
Mitral valve death (powder):
Subsequent to catheterization and
mitral-valve-replacement procedures, a patient died of acute mitral
occlusion from a flapping mural
thrombus. 34 Histopathological
analysis identified foreign microbodies at the center of the clot.
Stent implantation (fibers/
powder): Whelan et al. observed
substantial contamination of coronary stents with textile fibers, glove
powder, or both, during experimental preparation and implantation. Of those studied with stent
thrombosis, 41.6% of the implants
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SURGICAL TECHNOLOGY INTERNATIONAL XII
Figure 7B. Wood Pulp/Polyester with Adhesive
Binders.
Figure 7A. Wood Pulp (paper).
Figure 7C. 280- count Polyester/Cotton washed.
Figure 7D. Polypropylene SMS (Spunbond/Meltblown/Spunbond).
Figure 7. These photomicrographs of surgical fabrics illustrate most commonly used materials. It is apparent that fabrics A, B, and C will readily produce lint
when the material rubs against itself, the surgical table, or other objects. D is a much smoother material with weld points to anchor the extremely long polypropylene filaments making it more difficult to create lint.
possessed starch contamination with
no fibers detected. Of those who
did not experience stent thrombosis, 11.8% were contaminated with
powder and 8.8% with textile
fibers. It was noted that some of the
powder granules were large enough
to easily clog the capillaries in
which they were lodged. They also
noted both powder particles and
fibers covered with adherent inflammatory cells and platelets, with
fibers incorporated into a newly
formed neointimal layer.35
Granulomas
(fiber): Tinker et al.
reported 45 consecutive cases of
cellulose fiber granuloma with
mild-to-severe consequences. Of
the 45 cases, 27 were extraperitoneal and 18 were intraperitoneal.36
Donor kidney contaminated (powder): Microbodies from perfusate
contaminated with glove powder
have been shown to render kidneys
unacceptable for transplantation, as
particles had become lodged in the
renal vessels and glomeruli.37
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ADHESIONS
Whether the debris initiates exaggerated inflammatory activity due to
foreign microbody activation or secondary to a delayed hypersensitivity
reaction, fibrin is deposited. The
strands form a scaffolding or matrix
that facilitates the movement of fibroblasts and leukocytes through the edematous and dynamic area.11 Granulomas
may be overlaid with fibrin where they
function as a web to wall off the
unwanted mass and often ser ve to
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Figure 8. Lint impinged on this filter was obtained by air sampling proximate to surgical site during
surgery. Room-filters will similarly impinge the fibers circulating in the room and take on the color of the
lint-contributing fabric facilitating source identification.16 Photograph provided by Michael P. Goheen, MS
of Indiana University School of Medicine.
attach the granuloma (or clot) to a nearby structure.10 Prior to "anchorage,"
granulomas may move with gravity and
fluid currents to remote sites of the
body or remain suspended if a high level
of fluid is present, as in the case of peritonitis.22,38
Once anchored to a structure, more
fibrin is deposited, which adds girth to
the nodule. Both ends of each fibrin
strand deposited must attach to something, perhaps to surface points on the
granuloma, the base structure to which
the granuloma is anchored, or adjacent
tissues or organs.10 As an inflammatory
response begins to resolve, the scaffolding of fibrin is no longer required. In
normal healing, fibrin "self-destructs"
with the release of fibrinolytic
enzymes.11 If either the release of these
enzymes is inhibited or granulomas persist (signaling the need to continue to
isolate the foreign microbody from the
rest of the body), the fibrin does not
self-destruct.
Continued presence of the fibrin
heralds the deposition of collagen.11 The
deposition of fibrin and connective tissues can become self-perpetuating, as
the granuloma creates constant irritation, potentially setting the stage for
chronic inflammation. These fibrous
adhesions become thicker and more
numerous, expanding the area of attachments. As the adhesion spreads and
becomes more dense, it can strangle the
blood supply to the occupied sections of
the organ, or constrict the organ's internal function (Fig. 6).39
Forty percent of all intestinal ob-
Table IV
Foreign Microbodies Imbedded in Adhesions
Duron
(1997)
Luijendijk
(1996)
Saxen
(1968)
Myllärniemi
(1967)
80%
NN
26%
16%
Cornstarch Powder
3%
5%
2%
1%
Sutures
2%
25%
NN
<1%
Lint (or fibers)
NN = Not noted in report
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structions are due to adhesions40 and
60%-70% of small bowel obstruction.41
Studies have shown that in the Western
World, between 90% and 100% of individuals who have surgery develop at
least one adhesion.42 Myllärniemi et al.
reported that foreign microbodies were
associated with 61% of post-surgical
adhesions in 1967 and 1968. 43,44 In
1993, foreign bodies were detected in
93% of the adhesions studied by Duron
et al. 45 Reports have estimated that
10%-20% of female infertility is caused
by adhesions.46-48
Researchers have reported that upon
histopathological examination some foreign particles (eg, glove powder) may
eventually dissolve, leaving little or no
trace;21 however, the granulomas and
adhesions they initiated may persist
potentially causing intestinal obstruction and infertility.49 Thus, the percentage of adhesion formation initiated by
foreign microbodies may be much higher than actually reported.
Table IV represents the findings of
histopathological studies on the etiological agents of post-surgical complications that focus primarily on adhesions.
The large differences in frequency percentages among the studies presumably
depend on the products used in the OR,
environmental controls, and personnel
practices.
In the United Kingdom, with a population of about 50 million people,
approximately 18,000 procedures for
amelioration of adhesions are performed annually.50 Mortality rates range
from 3%-5% for simple obstructions to
approximately 30% when the intestine
is strangulated, necrotic, or
perforated.50
Cost
In Europe, a total of 59 patients
admitted to the University Hospital,
Rotterdam, for symptoms related to
adhesions were followed closely for
costs associated with their medical management. Of these, 35 required surgery
for adhesiolysis. The complication rate
was high (70%) with a 13% operative
mortality rate. Financial costs were
recorded as DFI 1,209,433 (approximately $720,000 U.S.).42 Costs included:
Surgical and operative clinic 7.7%
Intensive care
6.5%
Laboratory & diagnostic tests 7.6%
Out-patient care
4.8%
Medications
3.4%
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SURGICAL TECHNOLOGY INTERNATIONAL XII
Figure 9A. Wood pulp from surgeon's binoculars.
Figure 9B. Polyester and wood pulp from or light shield.
Figure 9. Samples were obtained with tweezers. Sampling positions were above the surgical site and could easily fall into the wound (16). Photographs provided
by Michael P. Goheen, MS of Indiana University School of Medicine.
Adhesions are currently the main
cause of bowel obstruction in Western
countries and account for more than
40% of cases of intestinal obstruction40
and 60%-70% of those involving the
small bowel.41 Adhesiolysis for bowel
strangulation or obstruction has a mortality rate of 10%.42 A 1988 U.S. study
calculated 281,982 hospitalizations for
lower-abdominal adhesiolysis required
948,727 days of inpatient care, at a cost
of approximately $1.2 billion of direct
hospital costs.51 U.S. cost calculations
were exclusive of out-patient and indirect patient-care costs.
Intestinal
obstruction (fiber): A
26-year-old female 2.5 weeks after
bilateral ovarian cysts were removed
was re-admitted with intestinal
obstruction. Surgery revealed bowel
severely adherent to all surrounding
structures, which was beefy red,
indurate, and friable. Recovery was
slow, painful, and the patient was
febrile. A 4-week course of prednisone provided marked improvement. An additional 4 weeks of
hospitalization were required.
Histopathology of adhesions
revealed foreign-body reaction to
cellulose fibers.24
Kidney strangulation (powder): A 21-year-old female suffered
severe retroperitoneal fibrosis with
chronic inflammation, pain, and
nausea four months after
ureterolithotomy. Abdominal exploration showed the entire right
ureter encased in hard, dense, adhesions, which strangled the blood
supply to the area and necessitated a
nephrectomy. Histopathology iden-
tified heavy foreign-microbody contamination imbedded in granulomas
throughout the adhesion tissues.39
Peritonitis and adhesions
(fiber): Janoff et al. identified 24
cases of cellulose fiber granulomatous reactions in three Portland area
hospitals. Six of these patients suffered severe granulomatous peritonitis with significant morbidity
and one mortality. Six other patients
had adhesions and granuloma formation that required re-operation,
but they did not have diffuse peritonitis. Six more experienced acute
abdominal pain and intestinal
obstruction with dense, thick, adhesions.24
VARIATIONS IN BIOREACTIVE
DETERMINANTS
Although contamination of surgical
sites with foreign debris will never be
entirely prevented, the products used
and practices implemented in the OR
can significantly affect the level and
reactive potential of foreign microbodies inadvertently implanted. Adverse
reactions are amplified and the mechanisms expanded by the physical characteristics of the microbody, base material
of composition, and type and amount of
substances absorbed to its surface.
In general, if the size is equal,
smoother particles typically elicit less
reactivity than angular or jagged surfaces. Both the physical configuration
and base chemical composition of
sutures, for example, impact the biological response. Braided, thicker sutures
are generally more bioreactive than
- 43 -
thinner, monofilament sutures. The
braided structure also presents more
protected areas, which may sequester
microbial growth. Composition of the
base material is significant not only as a
potentiator of surgical-site infections,
but also with regard to its capacity to
amplify inflammation (see Table III).52
In vivo experiments and post-surgical
case studies noted varying levels of
pathological response to foreign debris
that may be related to the patient, but
appear at other times apparently dependent on variations in the composition of
the lint, glove powder, suture, etc.
Treatments and the presence of
absorbed substances also impact the
type and level of pathological response.
Studies have demonstrated that cornstarch powder itself is capable of producing foreign-body and inflammatory
reactions. After placement onto the surface of the glove, powder particles may
also absorb unbound glove chemicals,
which can cause dermatitis on the hands
of healthcare professionals and others
who wear gloves.53 As granulomas and
adhesions may be formed as a result of
each of these biological reactions, it is
possible that more than one mechanism
is involved for any patient with these
complications. More severe reactions
may often be experienced by individuals
who have a Type IV hypersensitivity to
the powder or, even more likely, to one
or more of the glove chemicals being
slowly leached from its surface.
The fabrics from which items used in
the OR are made vary tremendously in
their capacity to generate lint.16 The
photomicrographs displayed (Fig. 7)
show the more easily abraded surfaces
of the wood pulp, wood pulp/polyester,
FINALPRINT
Impact of Microscopic Foreign Debris on Post-Surgical Complications
TRUSCOTT
Figure 10. Under polarized light, the glove cornstarch particles display typical birefringence referred to as
the Maltese Cross formation. Use of polarized light during histopathological microscopic examination of
tissue would display similar appearance. Alternatively, the specimen may be stained with Lugol's stain
causing cornstarch to appear purple or PAS stain that will cause the starch to appear dark pink.
and washed cotton fabrics compared to
the smooth polypropylene Spunbond/Melt-blown/Spunbond (SMS).
The wood pulp and wood pulp/polyester fibers snag easily and are readily
released from fabric as lint. The
polypropylene SMS microstructure is
made of continuous filaments "welded"
together at frequent points to prevent
accessibility to the strands. However, it
is important to note that some manufacturers of SMS drapes use materials
such as wood pulp/polyester in the fenestration inserts to increase absorption
properties. This practice, however,
increases linting at the most critical
area–the surgical site.18
Edmiston et al. reported a dramatic
drop in particulate contamination when
polypropylene replaced the existing
wood pulp/polyester fabrics. They also
reported that it took several weeks for
the lint from wood pulp/polyester fabrics to be cleaned entirely from the
room, as lint from fabrics removed days
and weeks previously continued to be
recovered from air-sampling filters
proximate to the surgical site (Fig. 8)
and tweezed from potentially critical
surfaces (Fig. 9).16 Interestingly, several
hospitals became aware of lint contamination when maintenance changed
intake filters of particulate-sensitive
computers. Lint had clogged the filters
and caused the control systems to overheat. The color of the trapped lint made
the source of the contaminating debris
obvious.
Verkkala et al. demonstrated that by
changing the OR staff garments and
textiles from which they were constructed, the airborne particle counts
fell from 850 particles/m3 to 50 particles/m 3 , microbial counts dropped
from 25 CFU/m3 to 7 CFU/m3, and
wound contamination dropped 46%
during sternal surgery and by more
than 90% during leg surgery.18
Surges in airborne-particulate production may occur when fabrics rub
together, move against the OR table, or
when instruments are moved across
their surfaces (abrasion). Paper seals
that fray upon opening and lasers tested
on items that disperse particles may
cause surges as well. Surges may also be
created by increased movement in the
room or when doors are opened or
closed. Furthermore, when powdered
gloves are donned and snapped,
removed and tossed, or punctured, a
surge of particulates is created.
In addition, microbodies may
become attached to medical devices.
For example, Green reported that the
surface of nylon catheters acquired a
static charge when removed from plastic packaging, which increased the
- 44 -
attraction for, and clinging of, particles
to the surface of catheters.54 The particulate contamination initiated heavy fibrin deposits over a 26-hour period with
the heaviest deposition over delivery
ports, potentially reducing drug flow.54
Stein similarly reported that instruments used in ocular surgery attracted
powder by way of static charge imparted to the surface of the instruments
after they had been pulled across sterile
plastic drapes.26
Endotoxin is another inflammatory,
potentiating contaminant present in
association with some microbodies
(glove powder, fibers). Depending on
the amount of endotoxin (pyrogenic
lipopolysaccharides from the cell walls
of Gram-negative bacteria), the adverse
events may range from heightened
inflammation (low), compliment activation, fever, clot formation, reduced
perfusion (of the heart, lung, and kidney), and disseminated intravascular
coagulation (DIC) to endotoxic shock
(high). It is interesting that while there
are strict requirements for non-pyrogenicity (low endotoxin) for most
intravascular devices, including heart
valves, vascular grafts, and angio-caths,
there are no endotoxin limits on the
gloves that handle them directly.
Fever (powder/endotoxin):
Febrile responses occurred in 8 of
69 patients after cardiac catheterization. Pyrogens were detected on
catheters only after being handled
with sterile powdered gloves. Incidence of febrile reactions was
reduced from 11.6% to 0.6% by
first rinsing gloves with pyrogenfree water prior to handling
catheters.55
Appropriate tissue preparation prior
to in vivo studies of foreign debris contamination is essential. Studies have
demonstrated that tissue must be traumatized to appropriately simulate the
surgical environment. Without this
preparation, studies may yield falsenegative results that may be interpreted
to be biocompatible.46
When comparing study conclusions
or merits, the relevance to the condition of the patient, local wound environment, particle characteristics, and
implantation technique is critical to
correctly assess the microbody's potential for causing post-surgical complications.
FINALPRINT
Surgical Overview
SURGICAL TECHNOLOGY INTERNATIONAL XII
RECOMMENDATIONS
Select low-linting or lint-free products whenever possible. If linting fabrics
are used, care should be taken to avert
the generation of airborne particulates.
Unfold or roll out rather than shake out
drapes. Avoid tearing paper products in
the OR. Do not rip tape from the sterilization wrap to which it is attached;
tear the tape itself instead. Cotton fabrics produce more lint after repeated
washings than they do when first used
(Fig. 7C).56 Thus, appropriate evaluation of this material should be conducted throughout the life of the fabric.
The source of linting in the OR may
be revealed by having maintenance save
all, or part of, the filters and pre-filters
used in the OR air circulators for observation. Replacement of filters for particulate-sensitive instruments and data
systems is very expensive. The move to
low-linting, powder-free products
demonstrates a cost avoidance that may
be helpful for upfront cost justification,
both in postoperative patient care and
routine instrument maintenance.
Surgical gloves should be powderfree. OR efforts to remove powder
from powdered gloves have not been
successful. Acknowledging the potential
adverse consequences of glove cornstarch powder, the U.S. Food and Drug
Administration (FDA) has required a
cautionary statement to be placed on all
powdered surgical gloves that reads:
Caution: "After donning, remove
powder by wiping with a sterile wet
sponge, sterile wet towel or other effective method."
U.S. compliance to this mandate has
been estimated to be 10%-17%. However, studies have shown this method to
be inadequate for powder removal.26,57
Although iodine removes powder more
effectively,58 the method is messy and
expensive. More impor tantly, any
iodine-contaminated powder clumps
left on the glove are more bioreactive
than starch alone.59 Others have tried
powder removal with alcohol, but this
method still leaves clumps and powder
in crevices that come forth when the
hands are flexed. Alcohol also degrades
several glove materials, which reduces
barrier integrity and increases the risk
of OR fires.
Even the best method of removing
powder from powdered gloves is
worthless in protecting the patient if the
gloves are punctured during the procedure, as powder from the inside of the
glove may spill into the surgical wound.
The only way to ensure powder microbodies do not contaminate the surgical
site is for surgeons, OR staff, and
instrument-handling personnel to use
powder-free gloves.
Select monofilament, thinner-gauge
sutures made of less provocative materials when possible, and remove all trim
fragments from the surgical site.
It is strongly recommended that
granuloma and adhesion specimens be
analyzed microscopically or with chemical-analysis techniques to identify etiological agents. The histopathologist can
observe prepared tissue sections microscopically for the presence of imbedded
debris. By altering the light source for
polarized light microscopy (Fig. 10),
glove powder and cellulose fibers may
be identified (birefringence or Maltese
Cross formation). Alternatively, Lugol's
(stains starch particles purple) or periodic acid Schiff (PAS) stain (stains starch
particles deep pink) may be used for
starch identification.
CONCLUSION
To recognize the impact foreigndebris contamination has on post-surgical outcomes, it is critical that
histopathological investigations be conducted when complications occur. The
etiological agent of the granulomatous
disease or adhesion should be identified.
Although foreign microbody complications may be treated successfully, the
optimum goal is prevention. To avoid
direct and indirect contamination of the
surgical site with foreign microbodies,
select low-linting OR and Central Service fabrics and maintain practices that
reduce particulate generation. Gloves
should be powder-free not only for the
surgeon, but for all OR staff members
and those preparing and handling surgical devices. Use the most biocompatible
sutures appropriate for the procedure
and remove all trim fragments. Reduction in patient morbidity and mortality,
as well as cost and time expended,
make foreign-microbody contamination
control well worth the effort. STI
- 45 -
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ACKNOWLEDGMENTS
I would like to express my sincere
appreciation to Esther Atkinson and
Susan Shoemake for their literature
research, editorial efforts, and administrative skills utilized in preparation of
this chapter.