Feature

Prospective, Nonrandomized Controlled

Trials to Compare the Effect of a Silk-Like
Fabric to Standard Hospital Linens on the

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Rate of Hospital-acquired Pressure Ulcers
Joseph Coladonato, MD; Annette Smith, RN, MSN; Nancy Watson, BSN, RN, CMSRN;
Anne T. Brown, RN, MSN, PCCN; Laurie L. McNichol, RN, MSN, GNP, CWOCN; Amy

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Clegg, MSN, RN, CWOCN; Tracy Griffin, BSB; Lora McPhail, RN, BSN; and Terry G.
Montgomery, PhD

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Abstract
Hospital bedding and gowns influence skin moisture, temperature, friction, and shear, which in turn may affect the de-
velopment of pressure ulcers. To evaluate the effect of a new silk-like synthetic fabric on the incidence of pressure ulcers

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in an acute care setting, two consecutive 6-month clinical trials were conducted among 307 consecutively admitted
patients in a Medical Renal Unit (August 2008 and March 2010) and in 275 patients admitted to a Surgical Intensive Care
Unit (ICU) (September 2009 to March 2010). During the first 8 weeks, all patients used standard hospital bed linens, re-
usable underpads, and gowns. During the second 8 weeks, all admitted patients used the intervention linens (a silk-like
fabric) followed by another 8 weeks of control (standard linen) use. Demographic variables and the prevalence of pres-
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sure ulcers on admission were statistically similar for control and intervention groups in both study populations with the
exception of gender in the Renal Unit study (13% higher proportion of men in intervention group). Average Braden Scores
were also similar and low (<18) in all study patients. Upon admission to the Medical Renal Unit, 21 of 154 patients (13.6%
) in the control and 26 of 153 patients (17.0%) in the intervention group had a pressure ulcer. The incidence of new ulcers
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was 12.3% in the control and 4.6% in the intervention group (P = 0.01); average length of stay was 5.97 days ( = 4.0) for
control and 5.31 days ( = 3.8) for intervention patients (P = 0.07). In the Surgical ICU group, 18 of 199 patients in the con-
trol (9.1%) and four of 76 patients in the intervention group (5.3%) were admitted with a pressure ulcer; the incidence of
new pressure ulcers was 7.5 % in the control and 0% in the intervention group (P = 0.01). Average length of stay was 4.5
days and 4.33 days in the control and intervention groups, respectively (P = 0.33). The significant differences between
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the control and intervention group in the rate of pressure ulcer development suggests that the type of linens used affect
pressure ulcer risk and that this silk-like synthetic fabric technology may help reduce the incidence of pressure ulcers in
high-risk patients. Controlled clinical studies in other patient populations are warranted.
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Keywords: clinical study, bedding and linens, pressure ulcer, prevention, incidence
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Index: Ostomy Wound Management 2012;58(10):1431

Potential Conflicts of Interest: Ms. McPhail and Dr. Montgomery disclose they are employees of Precision Fabrics
Group, Inc, Greensboro, NC, the manufacturer of the study fabric.
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Dr. Coladonato is Medical Director, Medical Renal Unit, Moses H. Cone Memorial Hospital, Greensboro, NC. Ms. Smith is Vice President of Nursing, Wesley
Long Community Hospital, Greensboro, NC. Ms. Watson is Assistant Director of Nursing Renal/Medical-Surgical; and Ms. Brown is Department Director-
Surgical ICU-2300, Moses H. Cone Memorial Hospital. Ms. McNichol is a Clinical Nurse Specialist/WOC Nurse, Wesley Long Community Hospital. Ms. Clegg
is a Nurse Practitioner, Moses H. Cone Memorial Hospital. Ms. Griffin is Director of Supply Chain Operations, Cone Health System. Ms. McPhail is a Nurse
Consultant and Dr. Montgomery is a Vice President, Precision Fabrics Group, Inc, Greensboro, NC. Please address correspondence to: Terry G. Montgomery,
PhD, Precision Fabrics Group, Inc, 301 North Elm Street, Suite 600, Greensboro, NC 27401; email: terry.montgomery@precisionfabrics.com.

14 ostomy wound management october 2012 www.o-wm.com


W hether patients are cared for at home, in hospitals, or
in nursing homes, their support surfaces are typically
covered by bed linens manufactured of fabrics comprised
of either polyester/cotton or 100% cotton fibers.1 Patient
gowns are made of similar fabrics. These cotton-blend fab-
rics have no special properties or performance attributes,
such as moisture management or antimicrobial properties,
despite the special needs of healthcare environments.2 In
most healthcare facilities, bed linens and patient gowns are
managed as housekeeping items.3 Although a patients skin
remains in constant contact with bedding and gown fabrics
during the hospital stay, these cotton linens and gowns are
not intended to be part of the therapeutic process.
The ability of a product to wick away moisture rapidly,
transport moisture vapor, and dry quickly are important fac-
tors in helping fragile skin stay dry and minimize macera-
tion.4-6 Reviews of the literature7-10 have determined that ex-
posure of tissue to moisture from perspiration, incontinence,
or wound exudate immediately increases these friction and
shear forces; prolonged exposure to moisture also increases
layers, causing maceration and epidermal ulceration.
Textiles and pressure ulcer formation. A limited number
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the adverse effects of friction and shear forces on tissue by
further weakening the intercellular bonds in the epidermal
of studies have specifically addressed both the effect of textile
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materials on skin moisture, temperature, friction, and shear
for patients in healthcare settings and the possibility that tex-
tile materials could play a role in formation and prevention
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of pressure ulcers. Biesecker et al4 evaluated commercially
available healthcare bed linens and reusable underpads to
determine which biomechanical properties reduce the devel-
opment of pressure ulcers. Specifically, two types of bedding
(100% cotton and 50% cotton/50% polyester) and eight un-
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derpads of differing constructions were mechanically tested
using an inclined plane and compared to assess their coef-
ficient of friction (COF) when wet and dry. The COFs of wet
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cottonbeddingandwetpolyester/cottonbeddingwerefound
to be almost two times greater than dry bedding.
Another biomechanical study by Pryczynska et al5 evalu-
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ated the effects of different bed linen fabric weave patterns
on frictional and moisture-management properties and how
they could affect the moisture, friction, and shear forces sur-
rounding bedbound patients. The shortcomings of tradi-
tional bedding with regard to the prevention of skin dam-
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age, such as abrasions and chafes and pressure ulcers, were
discussed. Three cotton-fiber blend levels were evaluated in
four weave patterns. The study verified the value of synthetic
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fibers, blended with cotton, in providing a smooth linen sur-
face, as well as an embossed fabric construction to facilitate
moisture drainage.
In a survey of the literature, Zhong et al 6 reviewed bio-
mechanical research related to the interactions between
textile materials and human skin; specifically, the skin
responses to moisture, heat transfer, and friction were
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Fabric-related pressure ulcers
Ostomy Wound Management 2012;58(10):1431
Key Points
Laboratory studies have shown that fabrics com-
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monly used in patient care environments may affect
skin moisture, shear, and friction, but clinical study
data are very limited.
The authors conducted controlled clinical studies in
two patient care units.
During the study, all admitted patients either used
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regular hospital linens (during a period of 8 weeks) or
linens composed of a silk-like synthetic fabric (for a
duration of 8 weeks).
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In both patient care units, the incidence of hospital-
acquired pressure ulcers (including Stage I) was lower
in the intervention than in the standard linen group.
The results of this study are encouraging and warrant
additional controlled clinical studies in other high-risk
patient populations.
discussed. The authors findings highlighted the difficulty
in relying on in vitro experiments to realistically represent the
skin/fabric biomechanical system; the authors concluded the
role textiles play in the formation and prevention of pressure
ulcers is generally understudied, despite its potential influ-
ence on factors that contribute to skin ulceration, specifically
pressure, shear/friction, and skin hydration.
Friction and fabrics. Friction is the adherent force that
resists shearing of the skin, which may result in epidermal
or dermal abrasion as the patient moves or is repositioned in
bed. Friction and shear can occur when a patient moves or
is moved across the coarse surface of a cotton bed sheet.4,11
Gerhardt11 conducted in vivo measurements to demonstrate
how epidermal hydration affects friction between the skin
and textile fabrics: 22 Caucasian participants (average age
31.7 years, average body mass index [BMI] 23.3) rubbed
their inner forearm against a hospital fabric and a plate
measuring force. Highly linear relationships between skin
moisture and skin-fabric friction were found for each par-
ticipant. Gerhardt also found that COFs of skin against wet
cotton-polyester fabric exceeded those of skin against dry
cotton-polyester fabric by a factor of more than two. In a ret-
rospective, correlation study12,13 of 347 patients (average age
69 years, 73.5% Caucasian, 13.8% Black/African American,
admitted to a medical-surgical ICU), data were collected on
65 pressure-related wounds, 20 Stage I, and 45 Stage II, Stage
III, and Stage IV ulcers. Development of Stage II, Stage III,
and Stage IV pressure ulcers was found to be almost six times
more likely for patients with high exposure to friction and
shear than in patients with low exposure.
New fabric technology. Recognizing deficiencies in the
ability of cotton-blend healthcare fabrics to keep patients
october 2012 ostomy wound management 15
Feature
fabric technology manufactured by Precision Fabrics Group,
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Figure 1. Photomicrograph comparison of silk-like fabric (left) and cotton-blend fabric (right).
skin dry and to minimize friction and shear,14 a new silk-like
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Inc (Greensboro, NC) was developed for use as bed linen or bed
sheetstoprovideagenerallycleaner,drier,smoothersurfacethan
that exhibited by cotton-blend fabrics, thus minimizing friction
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between the skin and fabric. As seen in Figure 1, continuous-
filament yarns woven into the silk-like synthetic fabric provide a
smooth support surface, free of broken or discontinuous fibers.
This enhanced smoothness helps minimize the potential for ir-
ritation and abrasion of sensitive skin. The silk-like fabric is a
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plain-weave construction of 100% continuous-filament yarns,
where 100% nylon yarns are woven in one direction of the fab-
ric, and >99% polyester yarns in the other (perpendicular) di-
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rection.The polyester yarns have a nonround fiber cross-section
to create microchannels to facilitate moisture wicking and rapid
drying more quickly than is possible with cotton (see Figures
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2 and 3).15 This new fabric technology also incorporates a du-
rable antimicrobial treatment to overcome cottons inherent
tendency to facilitate the growth of bacteria.16To control growth
of odor- and stain-producing bacteria and fungi, a commer-
cially available antimicrobial agent a quaternary ammonium
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compound (3-Trimethoxy silyl propyl dimethyl octadecyl am-
monium chloride) is applied to the fabric.17
The purpose of this study was to evaluate the effect of bed
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linens, underpads, and patient gowns made with the silk-like
fabrics (hereafter referred to as the Intervention) in reduc-
ing the development of pressure-induced wounds.
Methods and Procedures
Two prospective, nonrandomized controlled trials were
conducted in succession at Moses H. Cone Memorial Hospital,
16 ostomy wound management october 2012
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A
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Greensboro, NC from August 2008 to March 2010. The initial
trial was conducted in the Medical Renal Unit from August 2008
to January 2009. Once the Medical Renal Unit trial was com-
pleted and the results were analyzed and reviewed, a decision
was made to repeat the trial in a separate unit within the hospital
with a different patient population similarly at risk for pressure
ulcers. The second trial took place in the Surgical Intensive Care
Unit (ICU) from September 2009 to March 2010. The fabric
evaluated in the studies (DermaTherapy) was developed and
manufactured by Precision Fabrics Group, Inc, Greensboro, NC.
To derive an appropriate sample size for the two studies,
available research involving the prevention of pressure ul-
cers was reviewed.18 In almost all cases, the number of par-
ticipants was <100. A sample size of two times the highest
sample size of the published studies ie, approximately 200
subjects was deemed appropriate.
Investigational Review Board (IRB) approvals for the
studies were obtained from the 17-member Moses Cone
Health System IRB.
Methodology. The study protocols for both trials in-
volved three sequential sessions. During the first 8 weeks of
each trial, all patients admitted to the study units who met
the inclusion criteria used the control items. During the sec-
ond 8-week period, all patients admitted to the study units
who met the inclusion criteria used the intervention items.
During the third 8-week period, all patients admitted to the
study units who met the inclusion criteria used the control
items. Patients whose stay in the units overlapped the control
and intervention sessions were excluded from the study data
ie, patients included in the study data were either on the
control or intervention items for their entire stay in the units.
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Feature
Figure 2. Moisture wicking rates of healthcare bedding
fabrics.15
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Figure 3. Drying rates of healthcare bedding fabrics.15
Products. Control items included a conventional,
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usual-care hospital flat top sheet, fitted bottom sheet,
pillowcase, underpad, and patient gown, all made with
cotton-blend fabrics. Intervention items included a flat
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top sheet, fitted bottom sheet, pillowcase, underpad, and
patient gown, all made with the silk-like fabric. The in-
tervention underpad was identical to the control under-
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pad with the exception of the top surface fabric; the layer
closest to the patients skin was comprised of the silk-
like fabric. The inner soaker layer and moisture barrier
used in the intervention underpad were the same as used
in the control underpad.
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Populations. The patient populations in the Medical Re-
nal Unit and the Surgical ICU were chosen because patients
had multiple comorbidities and had been identified as being
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at high-risk for pressure ulcer development.
Inclusion/exclusion criteria. The inclusion criteria for
both trials included male or female patients of any race, ad-
mitted to the Units for a minimum of two consecutive days
(48 hours). Patients who were placed on specialty beds (eg,
pressure-reduction beds, bariatric beds) upon admission or
during their hospital stay were excluded.
18 ostomy wound management october 2012
Study protocol. A convenience sampling method was
used and all patients admitted or transferred to the Renal
Unit who met the inclusion criteria were asked to consent
to be part of the trial. As a result of the experiences and
results from the Renal Unit study, no informed consent
was obtained from patients in the subsequent Surgical
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ICU study. This deviation from the study protocol was ap-
proved by the IRB.
Care protocol. All enrolled patients received treatment
normally provided for their medical needs for the duration
of the study. Standard care treatment included the appro-
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priate use of pressure-reduction positioning, ongoing man-
agement for nutritional stability, moist wound dressings for
participants admitted with a pressure ulcer, and appropriate
incontinence management for all study patients.
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One deviation from standard care protocols occurred in
the Surgical ICU study. During the control study period,
standard ICU departmental patient-care protocols were
used; patients with early signs of a pressure ulcer were placed
directly on mattress overlays, without the use of fitted sheets.
Patients who did not exhibit early signs of a pressure ulcer re-
mained on standard-care cotton fitted sheets. During the in-
tervention session, the intervention fitted sheets were placed
over the mattress overlays when overlays were used. No other
modifications were made in the ICU standard-care protocols.
This deviation in the ICU study protocol also was approved
by the Investigational Review Board.
Data collection. The following variables were collected at
admission and extracted from the records of all patients who
participated in the two studies:
Patient demographic data weight, gender, age, and the
medical diagnosis of each patient;
Patient history and comorbidities, including but not
limited to hypertension, anemia, diabetes, and kidney
disease;
Albumin level, a basic screening tool for monitoring pro-
tein levels and used as a part of the standard care protocol
at Cone Health System. Albumin levels are an indicator
of nutritional status and fluid balance. Albumin measure-
ments below normal levels of 3.6 g/dL have been found to
indicate a potential risk for pressure ulcer formation19,20;
Braden scores, a widely used and validated assessment
tool available to assess patients risk of developing pres-
sure wounds.21 In addition to admission assessment, the
Braden Scale score was obtained on a daily basis, consis-
tent with hospital protocol. For the purpose of this study,
only admission Braden Scale scores were used. Each pa-
tients primary nurse recorded daily skin assessments per
hospital protocols.
In both studies, the primary endpoint was the develop-
ment of new pressure ulcers. For patients with a pressure
ulcer, computerized case report forms were used to record
and monitor wound information including wound loca-
tion, stage, size, wound bed color, drainage, and condition of
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Feature

Table 1. Medical Renal Unit study: patient variables Scale.21 Patients were otherwise provided the usual standard
of care. Only data from wounds identified as Stage I through
Control Intervention Stage IV pressure ulcers, unstageable ulcers, and deep tissue
groups group injury (DTI) wounds were collected. Other wounds, such as
(n=154) (n=153) postoperative surgical site infections or soft-tissue infections,
were not included.

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Variable Mean SD Mean SD P Data storage. Two files were used to de-identify patient
criteria and protect patient confidentiality: one included the
Weight (Kg) 80.0 25.0 78.9 20.2 .32 patients medical record numbers and was linked to the sub-
jects study ID numbers. This file, linking patients medical
Age (years) 63.2 14.0 62.5 16.5 .23
record numbers and their study ID numbers, was maintained

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Albumin level (g/dL) 2.84 0.6 2.80 0.8 .32 in a secure location within the Cone Health System, accessi-
ble only to those individuals who were authorized to view it.
A second separate file, which included the data
Table 2. Medical Renal Unit study: patient comorbidities collection tool, was only linked to the subjects

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study ID numbers.
Control groups Intervention group Data analysis. Descriptive statistics were
(n=154) (n=153) used to summarize all demographic, comor-
bidity, and outcome variables. Intervention
Comorbidity n(%) SD n (%) SD P

Hypertension

Anemia

Diabetes
117 (76.0%)

101 (65.6%)

82 (53.2%)
0.4

0.5

0.5
108 (70.6%)

78 (51.0%)

75 (49.0%)
PL0.5

0.5

0.5
.14

.005

.23
and control group averages were compared
using the t-test, assuming equal variance; for
comparisons, P <0.05 was considered statisti-
cally significant.
Statistical calculations were performed us-
ing StatPlus Professional software (v2009),
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AnalystSoft, Inc, Alexandria, VA.
Renal failure 80 (52.0%) 0.5 68 (44.4%) 0.5 .10
Results
Kidney disease 53 (34.4%) 0.5 50 (32.7%) 0.5 .37
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Medical Renal Unit study. A total of 307

Atherosclerosis 50 (32.5%) 0.5 48 (31.4%) 0.5 .31 patients were enrolled in the study on the
Medical Renal Unit. Of those, 154 were in the
Pulmonary 44 (28.6%) 0.5 40 (26.1%) 0.5 .32 control and 153 in the intervention group; in
the control group 59 were men and 95 were
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Heart failure 32 (20.8%) 0.4 23 (15.0%) 0.4 .10 women, compared to 78 men and 75 women
in the intervention group (P = 0.02). On ad-
Cerebrovascular 27 (17.5%) 0.4 27 (17.6%) 0.4 .49 mission, with the exception of gender, no sig-
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accident nificant differences in demographic variables

(weight, age, and albumin level) were observed.
Infectious disease 20 (13.0%) 0.3 27 (17.6%) 0.4 .13
The average weight of the control and the in-
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Neoplasm 20 (14.3%) 0.4 25 (16.3%) 0.4 .31 tervention patients was 80.0 Kg ( = 25.0) and
78.9 Kg ( = 20.2), respectively (P = 0.32). Av-
Drugs/alcohol 14 (9.1%) 0.3 25 (16.3%) 0.4 .03 erage ages of the control and the intervention
patients were 63.2 years ( = 14.0) and 62.5
Thrombophlebitis 12 (7.8%) 0.3 14 (9.2%) 0.3 .34 years ( = 16.5), respectively (P = 0.23). The
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proportion of men in the intervention session

Myocardardial 10 (6.5%) 0.3 15 (9.8%) 0.3 .15
was 13% higher than in the control group (P =
infarction
0.02), and albumin levels for control and inter-
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Dementia 8 (5.2%) 0.2 17 (11.1%)
surrounding skin. All pressure ulcers were documented and
staged per National Pressure Ulcer Advisory Panel (NPUAP)
guidelines by staff nurses who are educated annually on as-
sessment and staging of pressure ulcers and use of the Braden
0.3 .03 vention patients averaged 2.84 g/dL ( = 0.6)
and 2.80 g/dL ( = 0.8), respectively (P = 0.32)
(see Table 1).
The vast majority of patients had several comorbidities,
including hypertension (225, 73.5%), anemia (179, 58.5%),
diabetes mellitus (157, 51.3%) and renal failure (148, 48.4%),
but few significant differences between patients in the control

20 ostomy wound management october 2012 www.o-wm.com

Feature

Table 3. Medical Renal Unit study: admission are considered at risk for developing pressure ulcers.21 Braden
Braden Scale scores scores for patients in the renal study averaged 17.1 in both
the control ( = 2.7) and intervention groups ( = 3.1) (P =
Control Intervention 0.49) (see Table 3). The collective data analysis of patients at
groups group admittance indicates a good homogeneous mix in the Renal
(n=154) (n=153) Unit Study.

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On admission, the percentages of patients with pressure
Mean SD Mean SD P ulcers in the control and intervention groups were 13.6% (
= 0.3) and 17.7% ( = 0.4), respectively (P = 0.21) (see Tables
Perception 3.19 0.6 3.15 1.8 .28
4 and 5). During the study, 19 of 154 patients (12.3%, =
Moisture 3.50 0.7 3.56 0.5 .19 0.3) in the control and seven out of 153 patients in the in-

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tervention group (4.6%, = 0.2) developed a pressure ulcer
Activity 2.66 0.9 2.56 1.0 .21 (P = 0.01) during an average length of stay of 5.97 days (
= 4.0) for control and 5.31 days ( = 3.8) for intervention
Mobility 2.98 0.6 2.94 0.8 .31 patients (P = 0.07). At discharge from the Renal Unit, 20.1%

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( = 0.4) of control patients still had a pressure ulcer, com-
Nutrition 2.49 0.7 2.53 0.7 .31 pared to 13.7% ( = 0.3) of intervention patients (P = 0.07).
The average number of days between admission and pres-
Friction 2.27 0.6 2.33 0.6 .18
sure ulcer development was 6.8 (n = 21 wounds; = 3.7) for
Total Braden Score 17.08 2.7 17.07

Table 4. Medical Renal Unit study: number of

pressure ulcers per patient
3.1

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.49 control versus 7.8 (n = 8 wounds; = 6.7) for intervention
patients. The average number of pressure ulcers per patient
in the control group increased from 0.188 to 0.279 (48%) be-
tween admission ( = 0.5) and discharge ( = 0.6) (P = 0.08),
while the average number of pressure ulcers per patient in
the intervention group decreased from 0.229 to 0.177 (23%)
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Control Intervention between admission ( = 0.6) and discharge ( = 0.5) (P =
groups group
0.19) (see Table 4).
(n=154) (n=153)
The average number of new pressure ulcers per patient
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Mean SD Mean SD P was 0.136 ( = 0.4) in the control and 0.052 ( = 0.3) in
the intervention group (P = 0.01). Of those, 0.11 new Stage I
Pressure ulcers at 0.188 0.5 0.229 0.6 .25 pressure ulcers per patient developed in the control group (
admission = 0.4) for a total of 17 pressure ulcers, while 0.04 new Stage
I pressure ulcers per patient for a total of six pressure ulcers
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All pressure ulcers 0.136 0.4 0.052 0.3 .01 developed in the intervention group ( = 0.2) (P = 0.02).
developed during Further, 10 pressure ulcers or 0.07 new Stage II and higher
stay
pressure ulcers per patient developed in the control group
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Stage I pressure 0.110 0.4 0.039 0.2 .02

( = 0.3), and three pressure ulcers or 0.02 new Stage II and
ulcers developed higher pressure ulcers per patient developed in the interven-
during stay tion group ( = 0.1) (P = 0.02). Patients using the interven-
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tion linens had 36.8% fewer pressure ulcers at discharge from

Stage II+ pressure 0.065 0.3 0.020 0.1 .02 the Renal Unit than patients in the control group (P = 0.05),
ulcers developed or 0.117 versus 0.279 wounds per patient, respectively. In the
during stay control group, 31 patients were discharged with 43 pressure
ulcers (61.4 %) compared to 21 patients in the intervention
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Pressure ulcers at 0.279 0.6 0.177 0.5 .05

group, who were discharged with 27 pressure ulcers (38.6
discharge
%). During the first 8-week control period, the average num-
ber of pressure ulcers per patient was 0.12 ( = 0.4). During
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and intervention groups were observed (see Table 2). Ane-
mia was more common in the control group, whereas drugs/
alcohol and dementia were more common in the interven-
tion group. The average total Braden score for all patients on
admission was 17.1, but differences in Braden subscale and
total score between control and intervention patients were
small (see Table 3). Patients with Braden scores of 15 to 18
the 8-week intervention period, the number of pressure ul-
cers per patient averaged 0.05 ( = 0.2). During the second
8-week control period, the number of pressure ulcers per pa-
tient averaged 0.16 ( = 0.4).
Surgical ICU study. A total of 275 patients were enrolled
in the Surgical ICU study. Of those, 117 were men and 82 were
women in the control group and 44 were men and 32 were

22 ostomy wound management october 2012 www.o-wm.com

Feature

Table 5. Medical Renal Unit: number of patients with pressure ulcers (PUs)

Control group 1 Control group 2 Control groups Intervention

N=98 N=56 1+2 group
N=154 N=153

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n (%) SD n (%) SD n (%) SD n (%) SD PC1 PC2 PC1+2

Patients with PUs: all stages

At admission 16 (16.3%) 0.4 5 (8.9%) 0.3 21 (13.6%) 0.3 26 (17.0%) 0.4 .45 .07 .21

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Developed PUs 10 (10.2%) 0.3 9 (16.1%) 0.4 19 (12.3%) 0.3 7 (4.6%) 0.2 .04 .003 .01
during stay

At discharge 21 (21.4%) 0.4 10 (17.9%) 0.4 31 (20.1%) 0.4 21 (13.7%) 0.3 .06 .23 .07

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Patients with Stage I PUs

At admission 3 (3.1%) 0.2 1 (1.8%) 0.1 4 (2.6%) 0.2 14 (9.2%) 0.3 .03 .10 .20

Developed PUs
during stay

At discharge
9 (9.2%)

11 (11.2%)

Patients with Stage II+ PUs

0.3

0.3
6 (10.7%)

5 (8.9%)
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0.3

0.3
15 (9.7%)

16 (10.4%)
0.3

0.3
5 (3.3%)

12 (7.8%)
0.2

0.3
.02

.18
.02

.40
.01

.22
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At admission 13 (13.3%) 0.3 5 (8.9%) 0.3 18 (11.7%) 0.3 14 (9.2%) 0.3 .15 .48 .23

Developed PUs 4 (4.1%) 0.2 6 (10.7%) 0.3 10 (6.5%) 0.2 3 (2.0%) 0.1 .16 .003 .02
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during stay

At discharge 14 (14.3%) 0.4 9 (16.1%) 0.4 23 (14.9%) 0.4 11 (7.2%) 0.3 .03 .03 .02

The most common comorbidities were hypertension

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Table 6. Surgical ICU study: patient variables (150, 54.5%), atherosclerosis (111, 40.4%), diabetes (92,
33.5%), and pulmonary problems (88, 32.0%). Only the pro-
Control Intervention portion of patients with pulmonary problems and anemia
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groups group
were significantly higher in the control than in the interven-
(n=199) (n=76)
tion group (see Table 7). The average total Braden scores were
Mean SD Mean SD P 16.2 ( = 2.8) in the control and 16.5 ( = 2.8) in the inter-
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vention group (P = 0.08) (see Table 8). The average number

Weight (Kg) 89.6 25.6 88.7 22.1 .40 of pressure ulcers per patient on admission was 0.131 ( =
0.5) in the control and 0.132 ( = 0.6) in the intervention
Age (years) 64.4 14.9 65.6 12.6 .28 group (P = 0.50) (see Table 9).
By the end of the 24-week trial period, a total of 15 pa-
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Albumin level (g/dL) 2.63 0.7 2.67 0.9 .38 tients had developed a pressure ulcer: 7.5% of patients in
the control groups developed nine Stage I and 12 Stage II or
women in the intervention group (P = 0.47). Average patient greater ulcers and 0% of patients in the intervention group
D

weight was 89.6 Kg ( = 25.6) in the control group and 88.7
Kg ( = 22.1) in the intervention group (P = 0.40). Average
patient age in the control and intervention groups was 64.4
years ( = 14.9) and 65.6 years ( = 12.6), respectively (P =
0.28). Albumin levels were low but not significantly different
between patient groups (average 2.63 g/dL ( = 0.7) and 2.67
g/dL ( = 0.9) (P = 0.38) (see Table 6).
developed pressure ulcers during an average length of stay
of 4.58 days ( = 4.0) for control and 4.33 days ( = 4.9) for
intervention patients (P = 0.33). The average number of days
between admission and pressure ulcer development was 3.4
days (range = 5 days; n = 21 wounds; = 1.6) for control
versus 0 days (range = 0 days; n = 0 wounds; = 0) for inter-
vention patients.

24 ostomy wound management october 2012 www.o-wm.com

Feature

Table 7. Surgical ICU study: patient comorbidities The average number of pressure ulcers per
patient in the control group increased from
Control groups Intervention group 0.131 to 0.186 (42%) between admission ( =
(n=199) (n=76) 0.5) and discharge ( = 0.6) (P = 0.16), while
the average number of pressure ulcers per pa-
n(%) SD n (%) SD P tient in the intervention group decreased from

TE
0.132 to 0.105 (20%) between admission (
Hypertension 112 (56.5%) 0.5 38 (50.0%) 0.5 .17 = 0.6) and discharge ( = 0.3) (P = 0.39) (see
Table 9).
Atherosclerosis 82 (41.0%) 0.5 30 (39.0%) 0.5 .41
On admission, the percentages of patients
Pulmonary 74 (37.0%) 0.5 14 (18.4%) 0.4 .002 with pressure ulcers in the control and inter-

A
vention groups were 9.1% ( = 0.3) and 5.3%
Diabetes 72 (36.0%) 0.5 20 (26.3%) 0.4 .06 ( = 0.2), respectively (P = 0.15) (see Table 10).
During the study, 15 of 199 patients (7.5%,
Neoplasm 46 (23.0%) 0.4 12 (15.8%) 0.4 .10 = 0.3) in the control and 0 of 76 patients in

IC
the intervention group (0%, = 0) developed
Heart failure 38 (19.0%) 0.4 15 (19.7%) 0.4 .45 a pressure ulcer (P = 0.01). At discharge from
the Surgical ICU, 11.6% ( = 0.3) of control
Renal failure 34 (17.0%) 0.4 11 (14.5%) 0.4 .31
patients still had a pressure ulcer compared to
Myocardardial
infarction

Anemia

Cerebrovascular
24 (12.0%)

16 (8.0%)

14 (7.0%)
0.3

0.3

0.3
6 (7.9%)

2 (2.6%)

3 (4.0%)
PL 0.3

0.2

0.2
.17

.05

.17
5.3% ( = 0.2) of intervention patients (P =
0.06).

Discussion
In acute care hospitals, the incidence of
pressure ulcers ranges from 3% to 29.5%, with
U
accident the higher rates found in critical care areas of
the hospital.21 In a national prevalence/inci-
Drugs/Alcohol 12 (6.0%) 0.2 5 (6.6%) 0.3 .43
dence study23,24 of data obtained between 1999
D

Pressure ulcers 12 (6.0%) 0.2 2 (2.6%) 0.2 .13 and 2004 in the United States, the overall num-
ber of patients who developed pressure ulcers
Asthma 10 (5.0%) 0.2 3 (4.0%) 0.2 .36 after admission in acute care settings remained
steady at 7.6%. In the current study, with the
Thrombophlebitis 10 (5.0%) 0.2 2 (2.6%) 0.2 .20 exception of 0% incidence for the intervention
T

group in the Surgical ICU study, the overall in-

The average number of new pressure ulcers per patient cidence of patients with pressure ulcers ranged from 4.6% to
was 0.106 ( = 0.4) in the control and 0.0 ( = 0) in the inter- 20.1% within the ranges found in the literature. Further,
O

vention group (P = 0.02). Of those, 0.05 new Stage I pressure the facility-acquired incidence for control patients in the
ulcers per patient developed in the control, while 0.0 new current study in the Renal and Surgical Intensive Care Units
Stage I pressure ulcers developed in the intervention group. was 12.3% and 7.5%, respectively. Although the incidence of
N

(P = 0.09). Further, 0.06 new Stage II and higher pressure
ulcers per patient developed in the control group and 0.0 new
Stage II and higher pressure ulcers developed in the interven-
tion group. (P = 0.02). Patients using intervention had 43.4%
fewer pressure ulcers at discharge from the Surgical ICU than
O
12.3% found in the Renal Unit study is higher than predicted
for a general acute care population, it is important to note
the Renal and Surgical ICUs selected for the current stud-
ies were more likely to reflect higher-than-normal incidence
rates, but the direct relationship between patients with renal

patients in the control group (P = 0.16), or 0.186 versus 0.105 failure as a comorbidity and the incidence of pressure ulcers
wounds per patient, respectively. In the control group, 23 pa- has not been well investigated. Relevant data can be found in
tients were discharged with 37 pressure ulcers (82%) com- a 2003 survey25 by the Victorian Quality Council (VQC) of
D

pared to four patients in the intervention group who were
discharged with eight pressure ulcers (18%). During the first
8-week control period, the average number of pressure ulcers
per patient was 0.13 ( = 0.4). During the 8-week interven-
tion period, the number of pressure ulcers per patient aver-
aged 0.0 ( = 0). During the second 8-week control period,
pressure ulcers per patient averaged 0.08 ( = 0.4).
48 health services in metropolitan, rural, and regional areas,
representing slightly more than 7,000 beds, conducted to bet-
ter understand the incidence of pressure ulcers for a range
of cohorts. In the VQC survey, patients with pressure ul-
cers with renal failure as a comorbidity were found to have
an incidence rate of 42%. Similarly, patients in ICUs are
typically bedbound, unconscious, with respiratory failure,

26 ostomy wound management october 2012 www.o-wm.com

Feature

Table 8. Surgical ICU study: admission Braden ulcer development for control patients in the current study
Scale scores fall within the range associated with patients in Renal Units
and ICUs as reported in the literature. However, it should be
Control Interven- noted that the 4.6% and 0% incidence rates in the Renal Unit
groups tion group and Surgical ICU associated with pressure ulcer development
(n=199) (n=76) for the intervention groups in the current study were gener-

TE
ally below the levels reported elsewhere.
Mean SD Mean SD P
Limitations
Perception 3.20 0.8 3.22 0.7 .33
Patients were not told into which groups they had been
Moisture 3.47 0.6 3.51 0.6 .15 placed, but due to the differences in product texture, the in-

A
tervention items were easily distinguished from the control.
Activity 2.04 1.0 2.04 1.0 .49 Members of the nursing staff also were able to identify the
intervention products, although their standards of care re-
Mobility 2.69 0.6 2.76 0.6 .08 mained consistent throughout the study.

IC
Due to the need to maintain segregation of control and
Nutrition 2.50 0.6 2.64 0.7 .004 intervention items and the logistical requirements associated
with laundering, both trials were carried out in three sequen-
Friction 2.28 0.6 2.36 0.6 .05
tial stages: 8 weeks on control items, followed by 8 weeks on
Total Braden Scores 16.2 2.8 16.5

Table 9. Surgical ICU study: number of pressure

ulcers per patient
2.8

PL
.08 intervention items, and then 8 weeks on control items. As
previously stated, patients involved in the transitions from
control to intervention products and intervention to control
products were excluded from the analyzed data. Only pa-
tients using either the control or intervention items for their
entire stay in the study units were included in the study data.
U
Control Intervention This arrangement did not allow for simultaneous random-
groups group ization of patients on the control and intervention products.
(n=199) (n=76) The effect of existing pressure ulcers as a risk factor for
D

developing additional pressure ulcers was not examined, but

Mean SD Mean SD P
baseline prevalence did not differ between the two groups.
Pressure ulcers at 0.131 0.5 0.132 0.6 .50 The studies were conducted in only two hospital units.
admittance Therefore, the results were limited to two patient popula-
tions: renal and surgical ICU patients.
T

All pressure ulcers 0.106 0.4 0.000 0.0 .02 Multiple steps were taken in this sequential study design to
developed during minimize bias: 1) baseline risks of pressure ulcers for patients
stay in the Intervention and Control groups were measured on
O

a daily basis throughout both studies to ensure consistency;

Stage I pressure 0.045 0.3 0.000 0.0 .09
2) demographic data, including weight, age, albumin levels,
ulcers developed
during stay
comorbidities, gender, and Braden scores at admittance for
N

the before and after control and intervention groups showed

Stage II+ pressure 0.060 0.3 0.000 0.0 .02 no clinically significant differences affecting bias; 3) before
ulcers developed and after control groups were included to reduce bias; 4) all
during stay groups were studied for 8 weeks with no overlap between
control and intervention group subjects with regard to prod-
O

Pressure ulcers at 0.186 0.6 0.105 0.3 .16 uct use; 5) study nurses were blinded with respect to study
discharge data and trends in wound care; 6) mattresses were identical
for all patients; 6) studies were sufficiently sized to detect
D

or immobilized for substantial time periods while undergo-
ing life support measures, which increases the risk of pres-
sure ulcers.25 A nested case-controlled study by Baumgarten
et al26 that evaluated extrinsic risk factors such as admission
to an ICU determined the odds of having pressure ulcers
were twice as high for persons with an ICU stay as for those
without an ICU stay. Thus, the incidence rates for pressure
clinically important differences in endpoints; 7) all wound
stages, including Stage I wounds, were included in the study
sample and the analysis; study data were analyzed with and
without Stage I pressure ulcers to assess the degree of con-
sistency in observations; and 8) patient participants were
examined daily by the nursing staff to determine the pres-
ence and stage of wounds. The nursing staff used NPUAP

28 ostomy wound management october 2012 www.o-wm.com

Feature

Table 10. Surgical ICU study: number of patients with pressure ulcers (PUs)

Control group 1 Control group 2 Control groups Intervention

N=101 N=98 1+2 group
N=199 N=76

TE
n (%) SD n (%) SD n (%) SD n (%) SD PC1 PC2 PC1+2

Patients with PUs: all stages

At admission 12 (11.9%) 0.3 6 (6.1%) 0.2 18 (9.1%) 0.3 4 (5.3%) 0.2 .07 .41 .15

A
Developed PUs 10 (9.9%) 0.3 5 (5.1%) 0.2 15 (7.5%) 0.3 0 (0%) 0.0 .002 .02 .01
during stay

At discharge 14 (13.9%) 0.3 9 (9.2%) 0.3 23 (11.6%) 0.3 4 (5.3%) 0.2 .03 .17 .06

IC
Patients with Stage I PUs

At admission 1 (1.0%) 0.1 1 (1.0%) 0.1 2 (1.0%) 0.1 1 (1.3%) 0.1 .42 .43 .41

Developed PUs
during stay

At discharge
3 (3.0%)

3 (3.0%)

Patients with Stage II+ PUs

0.2

0.2
3 (3.1%)

4 (4.1%)
PL
0.2

0.2
6 (3.0%)

7 (3.5%)
0.2

0.2
0 (0%)

1 (1.3%)
0.0

0.1
.07

.23
.06

.14
.06

.17
U
At admission 11 (10.9%) 0.3 5 (5.1%) 0.2 16 (8.0%) 0.3 3 (4.0%) 0.2 .05 .36 .12

Developed PUs 9 (8.9%) 0.3 2 (2.0%) 0.1 11 (5.5%) 0.2 0 (0.0%) 0.0 .004 .11 .02
D

during stay

At discharge 13 (12.9%) 0.3 6 (6.1%) 0.2 19 (9.6%) 0.3 3 (4.0%) 0.2 .02 .26 .06

guidelines for staging wounds, but because multiple nurses thereby,contributetobetterhealthcareoutcomesforpatients

T

were involved in making wound assessments, bias could have at risk for or who have pressure ulcers. Additional studies in
occurred in interpretations of guidelines and the potential other populations such as long-term care are warranted. n
transient nature of Stage I pressure ulcers must be taken into
O

consideration. However, any wounds in question during the References

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