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Prospective, nonrandomized controlled trials to compare the effect of a silk-Like Fabric to standard Hospital Linens on the rate of Hospital-acquired Pressure ulcersJoseph 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 Clegg, MSN, RN, CWOCN; Tracy Griffin, BSB; Lora McPhail, RN, BSN; and Terry G. Montgomery, PhD

abstractHospital 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 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-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 was 12.3% in the control and 4.6% in the intervention group (P = 0.01); average length of stay was 5.97 days (σ = 4.0) for control and 5.31 days (σ = 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 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.

Keywords: clinical study, bedding and linens, pressure ulcer, prevention, incidence

Index: Ostomy Wound Management 2012;58(10):14–31

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.

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: [email protected].

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FabrIc-reLated Pressure uLcers

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 patient’s 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 the adverse effects of friction and shear forces on tissue by further weakening the intercellular bonds in the epidermal layers, causing maceration and epidermal ulceration.

textiles and pressure ulcer formation. a limited number of studies have specifically addressed both the effect of textile 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 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-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 cotton bedding and wet polyester/cotton bedding were found to be almost two times greater than dry bedding.

another biomechanical study by Pryczynska et al5 evalu-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-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 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 al6 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

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’

Key Points• Laboratory studies have shown that fabrics com-

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 regular hospital linens (during a period of 8 weeks) or linens composed of a silk-like synthetic fabric (for a duration of 8 weeks).

• 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.

ostomy wound management 2012;58(10):14–31

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skin dry and to minimize friction and shear,14 a new silk-like fabric technology manufactured by Precision Fabrics group, Inc (greensboro, nc) was developed for use as bed linen or bed sheets to provide a generally cleaner, drier, smoother surface than that exhibited by cotton-blend fabrics, thus minimizing friction 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 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-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 2 and 3).15 this new fabric technology also incorporates a du-rable antimicrobial treatment to overcome cotton’s inherent tendency to facilitate the growth of bacteria.16 to control growth of odor- and stain-producing bacteria and fungi, a commer-cially available antimicrobial agent — a quaternary ammonium 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 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 Procedurestwo prospective, nonrandomized controlled trials were

conducted in succession at moses H. cone memorial Hospital,

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.

Figure 1. Photomicrograph comparison of silk-like fabric (left) and cotton-blend fabric (right).

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Products. control items included a conventional, 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 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-pad with the exception of the top surface fabric; the layer closest to the patient’s 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.

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 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.

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 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-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.

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: • Patientdemographicdata—weight,gender,age,andthe

medical diagnosis of each patient; • Patient history and comorbidities, including but not

limited to hypertension, anemia, diabetes, and kidney disease;

• Albuminlevel,abasicscreeningtoolformonitoringpro-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;

• Bradenscores,awidelyusedandvalidatedassessmenttool 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-tient’s 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

Figure 2. Moisture wicking rates of healthcare bedding fabrics.15

Figure 3. Drying rates of healthcare bedding fabrics.15

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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

scale.21 Patients were otherwise provided the usual standard of care. only data from wounds identified as stage I through stage IV pressure ulcers, unstageable ulcers, and deep tissue injury (dtI) wounds were collected. other wounds, such as postoperative surgical site infections or soft-tissue infections, were not included.

data storage. two files were used to de-identify patient criteria and protect patient confidentiality: one included the patients’ medical record numbers and was linked to the sub-jects’ study Id numbers. this file, linking patients’ medical record numbers and their study Id numbers, was maintained 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 collection tool, was only linked to the subjects’ study Id numbers.

data analysis. descriptive statistics were used to summarize all demographic, comor-bidity, and outcome variables. Intervention 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), analystsoft, Inc, alexandria, Va.

resultsmedical renal unit study. a total of 307

patients were enrolled in the study on the medical renal unit. of those, 154 were in the control and 153 in the intervention group; in the control group 59 were men and 95 were women, compared to 78 men and 75 women in the intervention group (P = 0.02). on ad-mission, with the exception of gender, no sig-nificant differences in demographic variables (weight, age, and albumin level) were observed. the average weight of the control and the in-tervention patients was 80.0 Kg (σ = 25.0) and 78.9 Kg (σ = 20.2), respectively (P = 0.32). av-erage ages of the control and the intervention patients were 63.2 years (σ = 14.0) and 62.5 years (σ = 16.5), respectively (P = 0.23). the proportion of men in the intervention session was 13% higher than in the control group (P = 0.02), and albumin levels for control and inter-vention patients averaged 2.84 g/dL (σ = 0.6) and 2.80 g/dL (σ = 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

table 2. medical renal unit study: patient comorbidities

Control groups(n=154)

Intervention group (n=153)

Comorbidity n(%) SD n (%) SD P

Hypertension 117 (76.0%) 0.4 108 (70.6%) 0.5 .14

Anemia 101 (65.6%) 0.5 78 (51.0%) 0.5 .005

Diabetes 82 (53.2%) 0.5 75 (49.0%) 0.5 .23

Renal failure 80 (52.0%) 0.5 68 (44.4%) 0.5 .10

Kidney disease 53 (34.4%) 0.5 50 (32.7%) 0.5 .37

Atherosclerosis 50 (32.5%) 0.5 48 (31.4%) 0.5 .31

Pulmonary 44 (28.6%) 0.5 40 (26.1%) 0.5 .32

Heart failure 32 (20.8%) 0.4 23 (15.0%) 0.4 .10

Cerebrovascular accident

27 (17.5%) 0.4 27 (17.6%) 0.4 .49

Infectious disease 20 (13.0%) 0.3 27 (17.6%) 0.4 .13

Neoplasm 20 (14.3%) 0.4 25 (16.3%) 0.4 .31

Drugs/alcohol 14 (9.1%) 0.3 25 (16.3%) 0.4 .03

Thrombophlebitis 12 (7.8%) 0.3 14 (9.2%) 0.3 .34

Myocardardial infarction

10 (6.5%) 0.3 15 (9.8%) 0.3 .15

Dementia 8 (5.2%) 0.2 17 (11.1%) 0.3 .03

table 1. medical renal unit study: patient variables


Intervention group

(n=153)

Variable Mean SD Mean SD P

Weight (Kg) 80.0 25.0 78.9 20.2 .32

Age (years) 63.2 14.0 62.5 16.5 .23

Albumin level (g/dL) 2.84 0.6 2.80 0.8 .32

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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

are considered at risk for developing pressure ulcers.21 braden scores for patients in the renal study averaged 17.1 in both the control (σ = 2.7) and intervention groups (σ = 3.1) (P = 0.49) (see table 3). the collective data analysis of patients at admittance indicates a good homogeneous mix in the renal unit study.

on admission, the percentages of patients with pressure ulcers in the control and intervention groups were 13.6% (σ = 0.3) and 17.7% (σ = 0.4), respectively (P = 0.21) (see tables 4 and 5). during the study, 19 of 154 patients (12.3%, σ = 0.3) in the control and seven out of 153 patients in the in-tervention group (4.6%, σ = 0.2) developed a pressure ulcer (P = 0.01) during an average length of stay of 5.97 days (σ = 4.0) for control and 5.31 days (σ = 3.8) for intervention patients (P = 0.07). at discharge from the renal unit, 20.1% (σ = 0.4) of control patients still had a pressure ulcer, com-pared to 13.7% (σ = 0.3) of intervention patients (P = 0.07). the average number of days between admission and pres-sure ulcer development was 6.8 (n = 21 wounds; σ = 3.7) for control versus 7.8 (n = 8 wounds; σ = 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 (σ = 0.5) and discharge (σ = 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%) between admission (σ = 0.6) and discharge (σ = 0.5) (P = 0.19) (see table 4).

the average number of new pressure ulcers per patient was 0.136 (σ = 0.4) in the control and 0.052 (σ = 0.3) in the intervention group (P = 0.01). of those, 0.11 new stage I pressure ulcers per patient developed in the control group (σ = 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 developed in the intervention group (σ = 0.2) (P = 0.02). Further, 10 pressure ulcers or 0.07 new stage II and higher pressure ulcers per patient developed in the control group (σ = 0.3), and three pressure ulcers or 0.02 new stage II and higher pressure ulcers per patient developed in the interven-tion group (σ = 0.1) (P = 0.02). Patients using the interven-tion linens had 36.8% fewer pressure ulcers at discharge from the renal unit than patients in the control group (P = 0.05), or 0.117 versus 0.279 wounds per patient, respectively. In the control group, 31 patients were discharged with 43 pressure ulcers (61.4 %) compared to 21 patients in the intervention group, who were discharged with 27 pressure ulcers (38.6 %). during the first 8-week control period, the average num-ber of pressure ulcers per patient was 0.12 (σ = 0.4). during the 8-week intervention period, the number of pressure ul-cers per patient averaged 0.05 (σ = 0.2). during the second 8-week control period, the number of pressure ulcers per pa-tient averaged 0.16 (σ = 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

table 3. medical renal unit study: admission braden scale scores


Intervention group

(n=153)

Mean SD Mean SD P

Perception 3.19 0.6 3.15 1.8 .28

Moisture 3.50 0.7 3.56 0.5 .19

Activity 2.66 0.9 2.56 1.0 .21

Mobility 2.98 0.6 2.94 0.8 .31

Nutrition 2.49 0.7 2.53 0.7 .31

Friction 2.27 0.6 2.33 0.6 .18

Total Braden Score 17.08 2.7 17.07 3.1 .49

table 4. medical renal unit study: number of pressure ulcers per patient


Intervention group

(n=153)

Mean SD Mean SD P

Pressure ulcers at admission

0.188 0.5 0.229 0.6 .25

All pressure ulcers developed during stay

0.136 0.4 0.052 0.3 .01

Stage I pressure ulcers developed during stay

0.110 0.4 0.039 0.2 .02

Stage II+ pressure ulcers developed during stay

0.065 0.3 0.020 0.1 .02

Pressure ulcers at discharge

0.279 0.6 0.177 0.5 .05

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women in the intervention group (P = 0.47). average patient weight was 89.6 Kg (σ = 25.6) in the control group and 88.7 Kg (σ = 22.1) in the intervention group (P = 0.40). average patient age in the control and intervention groups was 64.4 years (σ = 14.9) and 65.6 years (σ = 12.6), respectively (P = 0.28). albumin levels were low but not significantly different between patient groups (average 2.63 g/dL (σ = 0.7) and 2.67 g/dL (σ = 0.9) (P = 0.38) (see table 6).

the most common comorbidities were hypertension (150, 54.5%), atherosclerosis (111, 40.4%), diabetes (92, 33.5%), and pulmonary problems (88, 32.0%). only the pro-portion of patients with pulmonary problems and anemia were significantly higher in the control than in the interven-tion group (see table 7). the average total braden scores were 16.2 (σ = 2.8) in the control and 16.5 (σ = 2.8) in the inter-vention group (P = 0.08) (see table 8). the average number of pressure ulcers per patient on admission was 0.131 (σ = 0.5) in the control and 0.132 (σ = 0.6) in the intervention group (P = 0.50) (see table 9).

by the end of the 24-week trial period, a total of 15 pa-tients had developed a pressure ulcer: 7.5% of patients in the control groups developed nine stage I and 12 stage II or greater ulcers and 0% of patients in the intervention group developed pressure ulcers during an average length of stay of 4.58 days (σ = 4.0) for control and 4.33 days (σ = 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; σ = 1.6) for control versus 0 days (range = 0 days; n = 0 wounds; σ = 0) for inter-vention patients.

table 5. medical renal unit: number of patients with pressure ulcers (Pus)

Control group 1N=98

Control group 2N=56

Control groups 1+2

N=154

Intervention groupN=153

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

Developed PUs during stay

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

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

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


9 (9.2%) 0.3 6 (10.7%) 0.3 15 (9.7%) 0.3 5 (3.3%) 0.2 .02 .02 .01

At discharge 11 (11.2%) 0.3 5 (8.9%) 0.3 16 (10.4%) 0.3 12 (7.8%) 0.3 .18 .40 .22

Patients with Stage II+ PUs

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


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

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

table 6. surgical Icu study: patient variables



Mean SD Mean SD P

Weight (Kg) 89.6 25.6 88.7 22.1 .40

Age (years) 64.4 14.9 65.6 12.6 .28

Albumin level (g/dL) 2.63 0.7 2.67 0.9 .38

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the average number of new pressure ulcers per patient was 0.106 (σ = 0.4) in the control and 0.0 (σ = 0) in the inter-vention group (P = 0.02). of those, 0.05 new stage I pressure ulcers per patient developed in the control, while 0.0 new stage I pressure ulcers developed in the intervention group. (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 patients in the control group (P = 0.16), or 0.186 versus 0.105 wounds per patient, respectively. In the control group, 23 pa-tients were discharged with 37 pressure ulcers (82%) com-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 (σ = 0.4). during the 8-week interven-tion period, the number of pressure ulcers per patient aver-aged 0.0 (σ = 0). during the second 8-week control period, pressure ulcers per patient averaged 0.08 (σ = 0.4).

the average number of pressure ulcers per patient in the control group increased from 0.131 to 0.186 (42%) between admission (σ = 0.5) and discharge (σ = 0.6) (P = 0.16), while the average number of pressure ulcers per pa-tient in the intervention group decreased from 0.132 to 0.105 (20%) between admission (σ = 0.6) and discharge (σ = 0.3) (P = 0.39) (see table 9).

on admission, the percentages of patients with pressure ulcers in the control and inter-vention groups were 9.1% (σ = 0.3) and 5.3% (σ = 0.2), respectively (P = 0.15) (see table 10). during the study, 15 of 199 patients (7.5%, σ = 0.3) in the control and 0 of 76 patients in the intervention group (0%, σ = 0) developed a pressure ulcer (P = 0.01). at discharge from the surgical Icu, 11.6% (σ = 0.3) of control patients still had a pressure ulcer compared to 5.3% (σ = 0.2) of intervention patients (P = 0.06).

discussionIn acute care hospitals, the incidence of

pressure ulcers ranges from 3% to 29.5%, with the higher rates found in critical care areas of the hospital.21 In a national prevalence/inci-dence study23,24 of data obtained between 1999 and 2004 in the united states, the overall num-ber of patients who developed pressure ulcers after admission in acute care settings remained steady at 7.6%. In the current study, with the exception of 0% incidence for the intervention group in the surgical Icu study, the overall in-

cidence of patients with pressure ulcers ranged from 4.6% to 20.1% — within the ranges found in the literature. Further, the facility-acquired incidence for control patients in the current study in the renal and surgical Intensive care units was 12.3% and 7.5%, respectively. although the incidence of 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 failure as a comorbidity and the incidence of pressure ulcers has not been well investigated. relevant data can be found in a 2003 survey25 by the Victorian Quality council (VQc) of 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,

table 7. surgical Icu study: patient comorbidities



n(%) SD n (%) SD P

Hypertension 112 (56.5%) 0.5 38 (50.0%) 0.5 .17

Atherosclerosis 82 (41.0%) 0.5 30 (39.0%) 0.5 .41

Pulmonary 74 (37.0%) 0.5 14 (18.4%) 0.4 .002

Diabetes 72 (36.0%) 0.5 20 (26.3%) 0.4 .06

Neoplasm 46 (23.0%) 0.4 12 (15.8%) 0.4 .10

Heart failure 38 (19.0%) 0.4 15 (19.7%) 0.4 .45

Renal failure 34 (17.0%) 0.4 11 (14.5%) 0.4 .31

Myocardardial infarction

24 (12.0%) 0.3 6 (7.9%) 0.3 .17

Anemia 16 (8.0%) 0.3 2 (2.6%) 0.2 .05

Cerebrovascular accident

14 (7.0%) 0.3 3 (4.0%) 0.2 .17

Drugs/Alcohol 12 (6.0%) 0.2 5 (6.6%) 0.3 .43

Pressure ulcers 12 (6.0%) 0.2 2 (2.6%) 0.2 .13

Asthma 10 (5.0%) 0.2 3 (4.0%) 0.2 .36

Thrombophlebitis 10 (5.0%) 0.2 2 (2.6%) 0.2 .20

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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

ulcer development for control patients in the current study fall within the range associated with patients in renal units and Icus as reported in the literature. However, it should be noted that the 4.6% and 0% incidence rates in the renal unit and surgical Icu associated with pressure ulcer development for the intervention groups in the current study were gener-ally below the levels reported elsewhere.

LimitationsPatients were not told into which groups they had been

placed, but due to the differences in product texture, the in-tervention items were easily distinguished from the control. members of the nursing staff also were able to identify the intervention products, although their standards of care re-mained consistent throughout the study.

due to the need to maintain segregation of control and intervention items and the logistical requirements associated with laundering, both trials were carried out in three sequen-tial stages: 8 weeks on control items, followed by 8 weeks on 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. this arrangement did not allow for simultaneous random-ization of patients on the control and intervention products.

the effect of existing pressure ulcers as a risk factor for developing additional pressure ulcers was not examined, but baseline prevalence did not differ between the two groups.

the studies were conducted in only two hospital units. therefore, the results were limited to two patient popula-tions: renal and surgical Icu patients.

multiple steps were taken in this sequential study design to minimize bias: 1) baseline risks of pressure ulcers for patients in the Intervention and control groups were measured on a daily basis throughout both studies to ensure consistency; 2) demographic data, including weight, age, albumin levels, comorbidities, gender, and braden scores at admittance for the before and after control and intervention groups showed no clinically significant differences affecting bias; 3) before and after control groups were included to reduce bias; 4) all groups were studied for 8 weeks with no overlap between control and intervention group subjects with regard to prod-uct use; 5) study nurses were blinded with respect to study data and trends in wound care; 6) mattresses were identical for all patients; 6) studies were sufficiently sized to detect 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

table 9. surgical Icu study: number of pressure ulcers per patient



Mean SD Mean SD P

Pressure ulcers at admittance

0.131 0.5 0.132 0.6 .50

All pressure ulcers developed during stay

0.106 0.4 0.000 0.0 .02

Stage I pressure ulcers developed during stay

0.045 0.3 0.000 0.0 .09

Stage II+ pressure ulcers developed during stay

0.060 0.3 0.000 0.0 .02

Pressure ulcers at discharge

0.186 0.6 0.105 0.3 .16

table 8. surgical Icu study: admission braden scale scores


Interven-tion group

(n=76)

Mean SD Mean SD P

Perception 3.20 0.8 3.22 0.7 .33

Moisture 3.47 0.6 3.51 0.6 .15

Activity 2.04 1.0 2.04 1.0 .49

Mobility 2.69 0.6 2.76 0.6 .08

Nutrition 2.50 0.6 2.64 0.7 .004

Friction 2.28 0.6 2.36 0.6 .05

Total Braden Scores 16.2 2.8 16.5 2.8 .08

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guidelines for staging wounds, but because multiple nurses were involved in making wound assessments, bias could have occurred in interpretations of guidelines and the potential transient nature of stage I pressure ulcers must be taken into consideration. However, any wounds in question during the study were adjudicated by an independent nursing observer.

conclusionsIn two separate studies involving a total of 582 patients,

the therapeutic performance of silk-like synthetic bedding and patient gown products was compared with conven-tional cotton-blend products currently used in hospitals and healthcare facilities. In both patient care settings, the inci-dence of pressure ulcers was lower in patients using the in-tervention than those using standard hospital linens. In the medical renal unit, the incidence of facility-acquired pres-sure ulcers was 12.3% in the standard compared to 4.6% in the intervention linen group. similarly, in the surgical Icu, the incidence of pressure ulcers was lower in the intervention (0 %) than in the control group (7.5%). these findings indi-cate that state-of-the-art synthetic textile materials have the potential to reduce the development of pressure ulcers and,

thereby, contribute to better healthcare outcomes for patients at risk for or who have pressure ulcers. additional studies in other populations such as long-term care are warranted. n

references1. 2005 North American Edition Comparative Operating Revenues and Ex-

pense Profile for the Healthcare Textile Maintenance Industry. Published by Phillips & Associates, Inc, 2006. Available at: www.trsa.org. Accessed September 14, 2012.

2 Internal testing of healthcare cotton-blend fabrics by Precision Fabrics Group, Inc, January – June, 2011.

3. Private communication from Terry Montgomery, Precision Fabrics Group Inc, June 6, 2012, after meeting with management representatives of fif-teen leading US healthcare institutions.

4. Biesecker JE, Thomas HL, Thacker JG, Blackwood HS, Edlich RF. Innova-tions in the design and performance of underpads for patients with burns. J Burn Care Rehab. 1995;16(1):66–73.

5. Pryczynska E, Lipp-Symonowicz B, Wieczorek A, Gaszynski W, Krekora K, Bittner-Czapinska E. Sheet fabrics with biophysical properties as elements of joint prevention in connection with first- and second-generation pneumatic anti-bedsore mattresses. Fibers Textiles Eastern Eur. 2003;4(43):50–53.

6. Zhong W, Xing MM, Pan N, Maibach HI. Textiles and human skin, mi-croclimate, cutaneous reactions: an overview. Cutan Ocul Toxicol. 2006;25(1):23–39.

7. Reger S. How does pressure, shear, friction and microclimate lead to ul-ceration. Presentation to the National Pressure Ulcer Advisory Panel, 11th Annual Conference, Arlington, VA. February 27–28, 2009.

8 Gray M, Black JM, Baharestani MM, Bliss DZ, Colwell JC, Goldberg M, et al. Moisture-associated skin damage: overview and pathophysiology. J WOCN. 2011;38(3):233–241.

table 10. surgical Icu study: number of patients with pressure ulcers (Pus)

Control group 1N=101

Control group 2N=98

Control groups 1+2

N=199

Intervention groupN=76

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


10 (9.9%) 0.3 5 (5.1%) 0.2 15 (7.5%) 0.3 0 (0%) 0.0 .002 .02 .01

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

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


3 (3.0%) 0.2 3 (3.1%) 0.2 6 (3.0%) 0.2 0 (0%) 0.0 .07 .06 .06

At discharge 3 (3.0%) 0.2 4 (4.1%) 0.2 7 (3.5%) 0.2 1 (1.3%) 0.1 .23 .14 .17

Patients with Stage II+ PUs

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


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

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

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FabrIc-reLated Pressure uLcers

9. Black JM, Gray M, Bliss DZ, Kennedy-Evans KL, Logan S, Baharestani M, et al. MASD Part 2: Incontinence-associated dermatitis and intertriginous dermatitis: a consensus. J WOCN. 2011;38(4):359–370.

10. Ayello EA, Baranoski S, Lyder C, Cuddigan J. Pressure ulcers. In: Baranos-ki S, Ayello EA, eds. Wound Care Essentials: Practice Principles. Philadel-phia, PA: Lippincott Williams & Wilkins. 2004;240-70.

11. Gerhardt LC, Strassle, Lenz A, Spencer ND, Derler S. Influence of epi-dermal hydration on the friction of human skin against textiles. J R Soc Interface. 2008;5(28):1317–1328.

12. National Pressure Advisory Panel 2011. Available at: www.npuap.org/pr2.htm. Accessed October 10, 2011.

13. Cox J. Predictors of pressure ulcers in adult critical care patients. Am J Crit Care. 2011;20(5):364–375.

14. Kurtz EJ, Ylverton CB, Camacho FT, Fleischer AB Jr. Use of a silk-like bedding fabric in patients with atopic dermatitis. Pediatr Dermatol. 2008;25(4):439–443.

15. Data from internal testing at Precision Fabrics Group, Inc. 2011.16. Pyrek KM. Medical Fabrics: A Reservoir of Pathogenic Bacterium? Infec-

tion Control Today. December 31, 2008. Available at: www.infectioncon-troltoday.com. Accessed April 8, 2009.

17. Quaternary ammonium antimicrobial agent is marketed as Aegis®; manu-factured by Microban. Available at: www.microban.com/. Accessed Janu-ary 6, 2012.

18. McInnes E, Jammali-Blasi A, Bell-Syer SEM, Dumville JC, Cullum N. Sup-port surfaces for pressure ulcer prevention. Cochrane Database System Rev. 2011;4:CD0017835.

19. Terekeci H, Kucukardali Y, Top C, Onem Y, Celik S, Oktenli C. Risk as-sessment study of the pressure ulcers in intensive care unit patients. Eur J Intern Med. 2009;20(4):394–397.

20. Beddhu S, Kaysen GA, Yan G, Sarnak M, Agodoa L, Ornt D, et al. As-sociation of serum albumin and atherosclerosis in chronic hemodialysis patients. Am J Kidney Dis. 2002;40(4):721–727.

21. Bergstrom N, Braden BJ, Laguzza A, Holman V. The Braden Scale for Pre-dicting Pressure Sore Risk. Nurs Res. 1987;36(4):205–210.

22. Pressure Ulcers in Adults: Prediction and Prevention. Clinical Prac-tice Guideline Number 3. Agency for Health Care Policy and Research (DHHS/PHS), Rockville, MD. 1992. Available at: www.eric.ed.gov/PDFS/ED357247.pdf. Accessed February 15, 2012.

23. Whittington KT, Briones R. National Prevalence and Incidence Study: 6-year sequential acute care data. Adv Skin Wound Care. 2004;17(9):490–494.

24. Reger S, Ranganathan VK, Sahgal V. Support surface interface pressure, microenvironment, and prevalence of pressure ulcers: an analysis of the literature. Ostomy Wound Manage. 2007;53(10):50–58.

25. Pressure Ulcer Prevalence Survey (PUPPS) Report 2003; State Govern-ment of Victoria, Australia, Department of Health. Available at: www.health.vic.gov.au/qualitycouncil/downloads/pupps2/-statepupps_report.pdf. Accessed February 15, 2012.

26. Baumgarten M, Margolis DJ, Localio AR, Kagan SH, Lowe RA, Kinosian B, et al. Extrinsic risk factors for pressure ulcers early in the hospital stay: a nested case-controlled study. J Gerontol A Biol Sci Med. 2008; 63(4):408-413.

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