A Prospective, Randomized, Multisite Clinical
Evaluation of a Transparent Absorbent Acrylic
Dressing and a Hydrocolloid Dressing in the
Management of Stage II and Shallow Stage III
Pressure Ulcers
Marie Brown-Etris, RN, CWOCN; Catherine Milne, APRN,BC, MSN, CWOCN; Heather Orsted, RN, BN, ET, MSc; Judy L. Gates, MSN, RN, BC, CWS, FCCWS;
Debra Netsch, RN, MSN, FNP, CWOCN; Marion Punchello, LPN; Nancy Couture, RN, IIWCC; Martine Albert, RN, BScN, ET; Edie Attrell, RN, BN, ET, IIWCC; and Julie Freyberg, RN, BSN, CWOCN
INTRODUCTION
An essential component of a successful pressure ulcer treat-ment plan is the selection of the proper dressing. It should be comfortable for the patient and able to manage wound drain-age and provide a warm, moist, protective environment for granulation and epithelial tissue to proliferate. Since their intro-duction in the early 1980s, and from the first reports of clinical Marie Brown-Etris, RN, CWOCN, is President, Etris Associates, Inc, Philadelphia, PA; Catherine Milne, APRN,BC, MSN, CWOCN, is an Advanced Practice Nurse, Connecticut Clinical Nursing Associates LLC, Bristol, CT; Heather Orsted, RN, BN, ET, MSc, is Co-Director and Course Coordinator, International Interprofessional Wound Care Course Departments of Medicine and Public Health Sciences, University of Toronto, Toronto, Ontario, Canada, and Clinical and Educational Consultant, Calgary, Alberta, Canada; Judy L. Gates, MSN, RN, BC, CWS, FCCWS, is Banner Health Program Director for Clinical OnBoarding - Arizona Region, Phoenix, AZ; Debra Netsch, RN, MSN, FNP, CWOCN, is a WOC Nurse and Family Nurse Practitioner, Wound and Ostomy Clinic, Mankato Clinic, Ltd, Mankato, MN, and Associate Director and Ostomy Faculty, Web WOC Nurse Education Program, Metropolitan State University, St. Paul, MN; Marion Punchello, LPN, Etris Associates, Inc, Philadelphia, PA; Nancy Couture, RN, IIWCC, is Community Care Coordinator, Home Care, Wound Clinic, Calgary Home Care, Calgary, Alberta, Canada; Martine Albert, RN, BScN, ET, is a member of the Skin and Wound Assessment and Treatment Team (SWAT), Calgary Home Care, Calgary, Alberta, Canada; Edie Attrell, RN, BN, ET, IIWCC, is Clinical Nurse Educator, Calgary Health Region, Calgary, Alberta, Canada; and Julie Freyberg, RN, BSN, CWOCN, is Co-partner in a Wound and Ostomy clinic, both in- and outpatient setting, Mankato Clinic Ltd, Mankato, MN.Acknowledgment:The authors thank James B. Lutz, Lutz Consulting LLC, who provided medical writing services on behalf of 3M Company. This study was funded by a grant from 3M Company. Submitted August 7, 2006; accepted in revised form March 26, 2007.
ABSTRACT
OBJECTIVE:To compare clinical performance of a transparent absorbent acrylic dressing (3M Tegaderm Absorbent Clear Acrylic Dressing [TAAD]; 3M Company, St Paul, MN) and a hydrocolloid dressing (HD [DuoDERM CGF, ConvaTec, ER Squibb & Sons, Princeton, NJ]) in the management of Stage II and shallow Stage III pressure ulcers.
DESIGN:Prospective, open-label, randomized, comparative, multisite clinical evaluation. Patients were followed up for a maximum of 56 days or until their ulcer healed. At weekly intervals, investigators conducted wound assessments and dressing performance evaluations.
SETTING:Wound care clinics, home care, and long-term care.
PATIENTS:Thirty-five patients received the TAAD, and 37 received the HD.
OUTCOME MEASURES:Dressing performance assessments, patient comfort, dressing wear time, and wound healing were measured.
RESULTS:The majority of investigator assessments favored the TAAD. Considerations given included the ability to center dressings over the ulcer (P= .005), ability to assess the ulcer before (P< .001) and after (P< .001) absorption, barrier properties (P= .039), patient comfort during removal (P< .001), overall
patient comfort (P= .048), conformability before (P= .026) and after (P= .001) absorption, ease of removal (P< .001), nonadherence to wound bed (P< .001), residue in the wound (P= .002), residue on periwound skin (P< .001), and odor after absorption (P= .016). Overall satisfaction favored the TAAD (P< .001), and a high value was placed on its transparent feature (P< .001). Mean (SD) wear time for the TAAD was 5.7 (2.55) days compared with 4.7 (2.29) days for the HD (P= .086). This 1-day difference in wear time was clinically noticeable by the investigators (P= .035). Wound closure for the 2 dressing groups was nearly identical (P= .9627).
CONCLUSIONS:Performance results favored the TAAD over the HD as standard treatment for Stage II and shallow Stage III pressure ulcers.
use on pressure ulcers in 1988,1hydrocolloid dressings (HDs) have become a common dressing of choice for use on Stages II and III, minimally to moderately draining pressure ulcers.
Hydrocolloids are somewhat variable in both design and function, but all are absorbent, adherent dressings that are used to protect the wound from external factors and provide a warm, moist environment conducive to wound healing. Modern hydrocolloids are less bulky and more compliant than their predecessors and are available in both regular and thin ver-sions that absorb variable amounts of wound drainage. Some hydrocolloids are fully occlusive, whereas others are semi-permeable to moisture vapor; considerable debate surrounds which is a better design.2Some hydrocolloids are bordered with transparent film to improve adhesion and reduce edge roll, whereas others attempt to accomplish this same feature with tapered and/or beveled edges. Although most hydrocolloids have greatly improved in design and function since their initial introduction, many still have limitations. The most notable of these limitations are the inability to visualize the wound, exudate, and periwound skin through the dressing; a relatively high-edge profile of some nonbordered versions; limited conformability; residue left in the wound and on the periwound skin from the formation of a liquefied gel; and a distinctive, unpleasant odor after absorption of wound drainage.
The inability to visualize the wound as well as exudate and periwound skin through the dressing means that hydrocolloids may be prematurely removed to monitor the wound. This can potentially disrupt the wound healing process, cause unneces-sary pain and discomfort to the patient, decrease clinician productivity, and add to the overall cost of treatment. Furthermore, the high-edge profile and limited conformability of some hydrocolloids can cause them to catch on to linen and clothing and prematurely roll off the skin. This may lead to unnecessary dressing changes with clinical, quality of life, productivity, and cost consequences to both the patient and caregiver. The formation of a liquefied hydrocolloid gel, with its distinctive unpleasant odor, can lead to incorrect assessments of infection and unnecessary use of antimicrobials.
A newer dressing, manufactured with a novel design, is now available to address the shortcomings of HDs. The product consists of a clear, absorbent, acrylic polymer pad sandwiched between 2 layers of transparent polyurethane film. The trans-parent polyurethane film covers and extends approximately 1 inch beyond the absorbent pad, forming a transparent adhesive border. This sandwich design encapsulates the clear absorbent pad and prevents meltdown of the dressing into the wound. The bottom layer is perforated to allow wound drainage to be taken up by the absorbent pad and is coated with an adhesive designed to adhere under both dry and moist conditions.
The 3 distinguishing features of this new dressing are its transparency, conformability, and fully synthetic absorptive polymer. Transparency of the dressing allows for monitoring of the wound without removal of the dressing. Conformability allows the dressing to mold to difficult body contours without losing its shape after absorption of fluid, and the synthetic nature of the material eliminates odor derived from bacterial decomposition of the dressing. The dressing is capable of managing up to moderate amounts of drainage.
The objective of this study was to compare clinical perfor-mance of this new transparent absorbent acrylic dressing (TAAD) to a conventional HD in the management of Stage II and shal-low Stage III, minimally to moderately draining pressure ulcers.
METHODS
Study Design
This study was a prospective, open-label, randomized, com-parative, multisite clinical evaluation of 2 adhesive absorbent wound dressings used in the treatment of Stage II and shallow Stage III, minimally to moderately draining pressure ulcers. Patients were enrolled across 5 study sites and a variety of health care settings, including extended-care facilities, out-patient wound care clinics, and home care agencies. Four of the study sites were located in the United States, and one was located in Canada. The study was conducted over a 19-month period, from January 8, 2003, through July 28, 2004. Criteria for changing the dressing included leakage, edge roll, loss of adhesion, soiling, or the need for wound inspection. Dressings were changed by the facility staff on an as-needed basis and by the investigators at (approximately) weekly follow-up visits. The follow-up period was 56 days or until the pressure ulcer healed, whichever was sooner. Wound healing was defined as closure of the epidermis.
Patient Recruitment
This study was conducted in compliance with Good Clinical Practice guidelines and the Health Insurance Portability and Accountability Act regulations.3,4 An ethics review was con-ducted before the start of the study, and all participants signed an informed consent before study enrollment. Data collection methods assured patient privacy at all times.
Patients were eligible to participate in the study if they were at least 18 years of age and met the study inclusion and exclusion criteria (Table 1). In cases where the patient had more than 1 qualifying ulcer, only 1 ulcer was considered for en-rollment in the study. In these cases, the ulcer with the highest pressure ulcer stage was enrolled.5If the ulcers were all of the same pressure ulcer stage, the ulcer with the largest surface area was enrolled.
Study Dressings
Patients were randomized to receive either the TAAD or HD for treatment of their ulcer. Multiple sizes of each dressing were available so that a variety of wound sizes could be enrolled into the study and the dressing size could be optimally matched to the needs of the wound. For the TAAD, the smaller dressing was a 4.4 5.0-inch bordered oval design (with an absorbent pad size of 2.43.0 inches), and the larger dressing was a 5.66.25-inch bordered oval design (with an absorbent pad size of 3.4 4.25 inches). In addition, a sacral-specific design was used when appropriate. For the HD, a 44-inch nonbordered square design, a 66-inch nonbordered square design, and 2 sizes of a triangular bordered dressing (45 and 67 inches) were used.
Wound and Periwound Skin Assessments
Wound and periwound skin assessments were performed by the investigators and were obtained at enrollment and at near-weekly intervals (7 F 3 days) throughout the study. Wound assessments considering the type and amount of drainage and the percentage of necrotic and granulation tissue present in the wound bed were made. Periwound skin assessments made included the amount of maceration and severity of erythema
and denudation. Photographs and wound tracings were obtained at the time of a patient’s enrollment into the study and at all dressing changes completed by the investigators.
Dressing Performance Assessments
Investigators involved in the study rated patient comfort and dressing performance at each of the weekly wound inspections throughout the study. Criteria for investigator-rated assess-ments of dressing performance are outlined in Table 2.
Data Analysis
Wound and periwound skin assessments were analyzed separately for the baseline assessments (at enrollment) and for the follow-up assessments (subsequent dressing changes). Dressing assessments with multiple measurements were averaged for each patient across the 8-week follow-up period. Descriptive statistics were calculated for all variables. The Wilcoxon rank-sum test (a nonparametric equivalent to the ttest) was used to test for differences between the treatment groups. Significance was assessed atPe.05, and trends toward significance were assessed atPe.10.
Table 2.
INVESTIGATOR-RATED DRESSING PERFORMANCE ASSESSMENTS
Assessments Made at Application Assessment Scale
Ease of application 1 = Very poor Ability to center dressing over ulcer 2 = Poor Ability to assess ulcer through dressing 3 = Acceptable Conformability before absorption 4 = Good
5 = Very good
Assessments Made at Removal Assessment Scale
Adhesion 1 = Very poor
Absorbency 2 = Poor
Wear time 3 = Acceptable
Barrier properties 4 = Good Patient comfort during removal 5 = Very good Overall patient comfort
Conformability after absorption Ease of removal
Nonadherence to wound bed Overall satisfaction
Ability to assess ulcer after absorption Overall value of transparency
Residue in the wound 1 = Excessive
Residue on skin 2 = Much
3 = Acceptable 4 = Little 5 = None
Odor 1 = Very strong
2 = Strong 3 = Acceptable 4 = Little 5 = None Table 1.
CRITERIA FOR PATIENT ENROLLMENT Inclusion Criteria
&Patients with at least 1 Stage II or shallow Stage III, minimally to moderately draining pressure ulcer on any anatomical location that, in the investigator’s opinion, could have been treated with an HD
&Patients with ulcers that could be paired with a size/configuration of study dressings to have a periwound skin margin consistent with the manufacturer’s package insert instructions
&Patients with pressure relief needs that were properly assessed and addressed
Exclusion Criteria
&Patients with skin disease or abnormal conditions on or near the product application site
&Patients with insulin-dependent diabetes that, in the investigator’s opinion, had inadequately controlled blood sugar
&Patients who were receiving steroid, immunosuppressive therapy, or radiation to the area where the pressure ulcer was located
&Patients with a history of hypersensitivity to adhesive tapes or adhesive wound dressings
&Patients who were participating in another clinical research study
Exclusion Criteria for Specific Wounds
&Wounds with more than 50% necrotic tissue or, in the opinion of the investigator, should have undergone debridement before application of an occlusive or semiocclusive dressing
&Wounds with greater than 1-cm undermining or tunneling
&Wounds that required use of a filling or packing material
&Wounds that required the dressing to be cut to a smaller size or to a specialty shape
&Wounds that exhibited clinical infection as evidenced by purulent, malodorous, or recent increase in drainage and/or periwound erythema, or elevated temperature, or required treatment with a concomitant medication or product
The percent of wounds that healed were compared with chi-square analysis. Since relatively few wounds attained complete healing, linear healing rate (LHR) was calculated as a surrogate end point. LHR has the added benefit of normalizing wounds of varying size and geometry. Data for these surrogate end points were extracted from the wound tracings, which were measured by computer planimetry. LHR was calculated for each wound using the methods proposed by Gillman6and used by Margolis.7,8Differences in LHR means were assessed with a ttest.
RESULTS
Patient Recruitment and Demographics
A total of 72 patients with Stage II and shallow Stage III, minimally to moderately draining pressure ulcers were enrolled in the study. Thirty-five patients were randomized to the TAAD group and 37 patients to the HD group. Demographic results are summarized in Table 3. With the exception of ulcer location, there were no statistically significant differences in demo-graphic characteristics between the 2 treatment groups.
Wound and Periwound Skin Assessments
Baseline and follow-up wound and periwound skin assess-ments are summarized in Table 4. There were no statistical differences between the 2 groups at any time during the study.
Patient Comfort and Dressing Performance Assessments
Investigator ratings of patient comfort and dressing perfor-mance at application and removal are summarized in Tables 5 and 6, respectively. The majority of dressing investigator assessments statistically favored the TAAD over the HD. Areas where TAAD was statistically favored over HD were ability to assess the ulcer before and after absorption, ability to center the dressing over the wound, wear time, barrier properties, patient comfort during removal, overall patient comfort, conformability before and after absorption, ease of removal, nonadherence to the wound bed, residue in the wound, residue on the skin, odor Table 3.
PATIENT DEMOGRAPHIC AND BASELINE CHARACTERISTICS
Variable Measures TAAD* HDyy P
Gender Male 13 (37.1%) 19 (51.4%) .225 Female 22 (62.9%) 18 (48.6%) Age, y Mean (SD) 78.3 (14.70) 72.7 (18.61) .157 Weight, lb Mean (SD) 141.1 (47.06) 142.3 (38.72) .905 Braden risk scorez Mean (SD) 14.9 (3.38) 15.0 (3.42) .886
Incontinence history No 12 (34.3%) 13 (35.1%) .940 Yes 23 (65.7%) 24 (64.9%) Initial ulcer stage II 23 (65.7%) 22 (59.5%) .584
III 12 (34.3%) 15 (40.5%) Time since ulcer
onset, day
Median (range) 21.0 (1-291) 32.0 (2-635) .169
Ulcer location§ Sacrum 15 (42.9%) 7 (18.9%) .032 Buttock 2 (5.7%) 12 (32.4%) Ischium 5 (14.3%) 7 (18.9%) Heel 4 (11.4%) 4 (10.8%) Other 9 (25.7%) 7 (18.9%) Color of drainage Serous 15 (42.9%) 15 (40.5%) .479
Sanguineous 4 (11.4%) 6 (16.2%) Serosanguineous 16 (45.7%) 14 (37.8%) Purulent None None Cannot determine None 2 (5.4%) Ulcer condition Worsening None 1 (2.7%) .327
Stable 24 (68.6%) 19 (54.1%) Improving 11 (31.4%) 16 (43.2%) Unknown None 1 (2.7%)
*3M Tegaderm Absorbent Clear Acrylic Dressing (3M Company, St Paul, MN).
yConvaTec DuoDERM CGF (ER Squibb & Sons, Princeton, NJ).
zCopyright Barbara Braden and Nancy Bergstrom, 1988.
§
Statistically significant (P < .05).
Table 5.
PERFORMANCE ASSESSMENTS MADE AT DRESSING APPLICATIONS DURING THE STUDY
Dressing
Assessment Mean (SD) TAAD HD P
Ease of application 4.7 (0.57) 4.5 (0.51) .122 Ability to center dressing over wound 4.8 (0.49) 4.2 (0.79) .005 Ability to assess ulcer before absorption 5.0 (0.09) 1.1 (0.34) <.001 Conformability before absorption 4.7 (0.44) 4.4 (0.65) .026
Table 4.
WOUND AND PERIWOUND SKIN ASSESSMENTS
Baseline Assessments Follow-up Assessments
Dressing Dressing
Assessment
Mean (SD) TAAD HD P TAAD HD P
Wound area, cm2 1.5 (1.69) 2.5 (4.86) .752 1.1 (2.33)* 1.6 (4.90)* .598 Drainage amount 2.1 (0.36) 2.1 (0.32) .697 1.9 (0.62) 1.7 (0.58) .212 Necrotic tissue 0.9 (1.12) 0.8 (1.30) .392 0.6 (0.80) 0.4 (0.93) .068 Granulation tissue 3.5 (0.89) 3.4 (1.10) .959 3.6 (0.68) 3.7 (0.74) .431 Periwound maceration 0.3 (0.85) 0.3 (0.86) .543 0.2 (0.63) 0.4 (0.90) .270 Periwound erythema 0.1 (0.36) 0.2 (0.45) 1.000 0.2 (0.32) 0.1 (0.14) .286 Periwound denudation 0.1 (0.40) 0.1 (0.23) .613 0.1 (0.13) 0.1 (0.15) .377
Scales used for wound and periwound assessments: drainage: 1 = absent; 2 = minimal; 3 = moderate; 4 = high; necrotic and granulation tissue and maceration: 0 = none;
1 = e25%; 2 = 26% – 50%; 3 = 51% – 75%; 4 = 76% – 100%; erythema and
denudation: 0 = none; 1 = mild; 2 = moderate; 3 = severe. *End-of-study measurement.
after absorption, overall satisfaction, and overall value of transparency.
Dressing Wear Time
Mean (SD) wear time was 5.7 (2.55) days for the TAAD and 4.7 (2.29) days for the HD, a difference of 1.0 days. This difference trended toward significance (P = .086) and was clinically noticeable, as the investigators involved in the study rated wear time of the TAAD significantly better than the HD ([P= .035] Table 6).
Wound Healing
Wound healing results for the 2 groups are summarized in Table 7. There were no differences, or trends toward differ-ences, in wound closure or LHR between the 2 dressings groups.
Adverse Events
There were 18 adverse events reported during the study. Ten were reported in the TAAD group, and 8 were reported in the HD group. None of the adverse events were related to the study dressings under evaluation.
DISCUSSION
This study reports on the clinical use of a new technology in absorbent wound dressings, which is distinctly different in design and formulation from all other classes of dressings used to treat chronic wounds (eg, hydrocolloids, foams, alginates,
hydrogels, etc). Results of this study favor the new dressing, which addresses performance and aesthetic limitations of HDs. In the current study, no significant differences in wound healing were found between the 2 dressing groups (Table 7). The percentage of ulcers that reached closure was nearly identical for the 2 dressings, and LHR did not differ. This indicates that the new dressing provides the same moist and protective wound healing environment as traditional HDs. Wound healing rates in the current study were higher than the expected values of 31% to 41% derived from a meta-analysis of the published literature for 8 weeks of treatment with HDs.9 This difference may be attributed to methodologic differences among the published studies, the most important being the exclusion from the current study of nonshallow Stages III and IV ulcers that required the use of additional filling material, which were included in the meta-analysis. Wound healing results of the current study are, however, consistent with the overall results of the meta-analysis, which concludes that there are no significant differences in wound healing rates among advanced dressings. This leads one to conclude that when choosing among advanced dressings, it is important to consider dressing features that affect patient comfort and performance, economics, clinician acceptance, and aesthetics of the dressing.
A major limitation of traditional HDs often cited by clinicians is that their basic appearance is opaque, which often leads to premature removal of the dressing to make wound observa-tions.10 – 12 In addition, the high-profile and adhesive edges of nonbordered hydrocolloids tend to catch on to linen and clothing, causing the dressings to prematurely roll off the skin. These 3 factors may limit the effective wear time of many HDs, which impacts directly upon nursing productivity, treatment cost, and patient’s quality of life.
In the current study, mean (SD) wear time of the TAAD on a combined group of Stage II and shallow Stage III pressure ulcers was 5.7 (2.55) days compared with 4.7 (2.29) days for the HD, a difference of 1.0 days. This difference trended toward statistical significance (P = .086) and was clinically noticeable, as the investigators involved in the study rated wear time of the TAAD significantly better (P= .035) than the HD (Table 6). It Table 6.
PERFORMANCE ASSESSMENTS MADE AT DRESSING REMOVALS DURING THE STUDY
Dressing
Assessment Mean (SD) TAAD HD P
Adhesion 4.2 (0.75) 4.2 (0.77) .923 Absorbency 4.5 (0.50) 4.3 (0.58) .074 Wear time 4.5 (0.68) 4.1 (0.77) .035 Barrier properties 4.6 (0.54) 4.3 (0.64) .039 Patient comfort during removal 4.9 (0.32) 4.2 (0.66) <.001 Overall patient comfort 4.8 (0.34) 4.4 (0.66) .048 Conformability after absorption 4.7 (0.41) 4.2 (0.71) .001 Ease of removal 4.9 (0.19) 4.3 (0.58) <.001 Nonadherence to wound bed 5.0 (0.05) 4.6 (0.59) <.001 Overall satisfaction 4.8 (0.35) 4.2 (0.59) <.001 Ability to assess ulcer after absorption 4.6 (0.54) 1.1 (0.40) <.001 Overall value of transparency 4.9 (0.21) 1.5 (1.22) <.001 Residue in wound 4.9 (0.20) 4.7 (0.40) .002 Residue on skin 4.9 (0.22) 4.3 (0.55) <.001 Odor 5.0 (0.14) 4.8 (0.39) .016
Table 7.
SUMMARY OF WOUND HEALING RATES
Variable Measures TAAD HD P
Wound closure Yes 21 (60.0%) 22 (59.5%) .963 No 14 (40.0%) 15 (40.5%) Linear healing rate, cm/wk Mean (SD) 0.10 (0.205) 0.12 (0.136) .6520
should also be noted that there was a significant difference (P = .05) in location of the ulcers between the 2 groups (Table 3), with more ulcers located in the difficult-to-treat sacral area for the TAAD group. Mean wear time for the HD group was longer than the expected 2.19 days (range, 1.0 – 3.4 days) derived from a meta-analysis of published literature.9As with wound healing rates, this difference is assumed to be methodologic in origin and due to the exclusion of nonshallow Stages III and IV ulcers in the current study.
In addition to limited wear time, many hydrocolloids have aesthetic problems related to their mode of action. All hydro-colloids function by absorbing fluid into a hydrocolloid matrix, which in turn can form an looking and unpleasant-smelling hydrocolloid gel. Depending on the formulation and design of the particular hydrocolloid, this gel can ‘‘melt down’’ and deposit residue in the wound or onto the periwound skin. Any action required to remove this residue may damage the wound bed or periwound skin. In the current study, the TAAD left significantly less residue in the wound (P= .002) and on the periwound skin (P< .001) than the HD. In addition, there was significantly less odor after absorption of wound drainage associated with the TAAD than with the HD (P= .016).
Although numerous studies have been published comparing healing rates of HDs on pressure ulcers,9 relatively few randomized, controlled studies have attempted to measure the more subjective elements of patient comfort and dressing performance. One study compared an HD with a moist gauze dressing and a sheet hydrogel dressing and found that clinicians preferred the sheet hydrogel dressing because of the ability to view the wound through the dressing.10These results are consistent with the current study and support the value of a transparent absorbent dressing among clinicians. Another study compared 2 HDs and found little difference between the dressings.13Finally, 2 studies compared a hydrocolloid with a foam dressing.14,15Both studies found no differences in ease of application. However, there were significant differences in ease of removal. The foam dressing proved favorable, and this was most likely attributable to the meltdown of the HDs.
Analysis of the investigator-rated dressing performance characteristics favored the TAAD over the HD in most instances. This included barrier properties (P = .039), patient comfort during removal (P < .001), overall patient comfort (P= .048), conformability before (P= .026) and after (P= .001) absorption, ability to assess the ulcer before (P< .001) and after (P < .001) absorption, ability to center the dressing over the ulcer (P= .005), ease of removal (P< .001), and nonadherence to the wound bed (P < .001). Of particular interest, overall satisfaction, which is a composite of all the dressing
perfor-mance and aesthetic properties, strongly favored the TAAD over the HD (P< .001), and the investigators also placed a high value on the transparent features of the TAAD (P< .001).
CONCLUSIONS
In this clinical evaluation of 72 patients with Stage II and shallow Stage III pressure ulcers, the TAAD was rated better than the HD on the majority of performance measures. Overall satisfaction, which is a composite of all the dressing perfor-mance criteria, strongly favored the TAAD over the HD (P< .001). Investigators also placed a high value on the transparency of the TAAD (P< .001). This feature may facilitate fewer dressing changes resulting in improved patient comfort, nursing productivity, and treatment cost. Results of this study suggest that use of the TAAD as a standard approach for Stage II and shallow Stage III pressure ulcers may positively affect patient comfort, clinical outcomes, clinician satisfaction, and wound care costs.
&
REFERENCES
1. Shannon ML, Miller B. Evaluation of hydrocolloid dressings on healing of pressure ulcers in spinal cord injury patients. Decubitus 1988;1:42-6.
2. Bolton LL, Monte K, Pirone LA. Moisture and healing: beyond the jargon. Ostomy Wound Manage 2000;46:51S-62S.
3. Good Clinical Practice, 21 C.F.R. Parts 11, 40, 54, 56, 312, 314. 2006. Available at: http://www.fda.gov/oc/gcp/regulations.html. Last accessed January 30, 2008. 4. Standards for Privacy of Individually Identifiable Health Information; Final Rule, 45 C.F.R.
Parts 160 and 164. Federal Register. 2002. Available at: http://www.hhs.gov/ocr/hipaa/ privrulepd.pdf. Last accessed January 30, 2008.
5. Panel for the Prediction and Prevention of Pressure Ulcers in Adults. Pressure Ulcers in Adults: Prediction and Prevention. Clinical Practice Guideline Number 3: Prediction and Prevention. Rockville, MD: Agency for Health Care Policy and Research, Public Health Service, US Department of Health and Human Services; 1992.
6. Gillman TH. Parameter for the measurement of wound closure. Wounds 1990;2:95-101. 7. Margolis DJ, Gross EA, Wood CR, Lazarus GS. Planimetric rate of healing in venous ulcers of the leg treated with pressure bandage and hydrocolloid dressing. J Am Acad Dermatol 1993;28:418-21.
8. Margolis DJ. Wound healing assessment: the clinical utility of wound healing rates. Ostomy Wound Manage 1994;40:20-2, 24, 26-7.
9. Kerstein MD, Gemmen E, Van Rijswijk L, et al. Cost and cost effectiveness of venous and pressure ulcer protocols of care. Dis Manage Health Outcomes 2001;9:651-63. 10. Mulder GD, Altman M, Seeley JE, Tintle T. Prospective randomized study of the efficacy
of hydrogel, hydrocolloid, and saline solution-moistened dressings on the management of pressure ulcers. Wound Repair Regen 1993;1:213-8.
11. Baxter H. A comparison of two hydrocolloid sheet dressings. Br J Community Nurs 2000;5(11):572, 574, 576-7.
12. Banks V, Hagelstein S, Thomas N, Bale S, Harding KG. Comparing hydrocolloid dressings in management of exuding wounds. Br J Nurs 1999;8:640-6.
13. Seaman S, Herbster S, Muglia J, Murray M, Rick C. Simplifying modern wound management for nonprofessional caregivers. Ostomy Wound Manage 2000;46:18-27. 14. Seeley J, Jensen JL, Hutcherson J. A randomized clinical study comparing a
hydrocellular dressing to a hydrocolloid dressing in the management of pressure ulcers. Ostomy Wound Manage 1999;45:39-44, 46-7.
15. Bale S, Squires D, Varnon T, Walker A, Benbow M, Harding KG. A comparison of two dressings in pressure sore management. J Wound Care 1997;6:463-6.
