The Ideal Split-Thickness Skin Graft Donor-Site Dressing: A Clinical Comparative Trial of a Modified Polyurethane Dressing and Aquacel

Summary of Scientific Article by Arjun Mehta, UCLA Bioengineering Undergraduate November 15, 2011

Authors:
Ulf Dornseifer, M.D., Daniel Lonic, M.D., Tristan Ivo Gerstung, M.D., Frank Herter, M.D., Andreas Max Fichter, M.D., Charlotte Holm, M.D., Ph.D., Tibor Schuster, Ph.D., Milomir Ninkovic, M.D., Ph.D.

Published: Plastic and Reconstructive Surgery. 2011. Introduction

Skin grafting still remains the most common form of tissue repair for severe tissue damage arising from burns, chronic wounds, and ulcers. Often, a patient can be treated via a split-thickness graft taken from another part of the body, such as the thigh. While the skin removed at the donor-site can still be regenerated, it must be treated with care in order to prevent infection and promote reepithelialization. As a result, many wound care dressings have emerged, such as BioBrane, Tegaderm, and Aquacel. The optimal dressing should have the following characteristics: protect the wound from desiccation, permit gas exchange to accelerate reepithelialization, be impermeable to exogenous microorganisms, be comfortable for the patient and ward staff, require minimal labor, be flexible and pliable, have a good tensile, and be resistant to linear and shear stress. Additionally, it should possess these characteristics while being low in cost. Existing dressings fulfill some of these criteria, but not all of them. Thus, there is still a need to create a better dressing Theoretically, a polyurethane film would be a superior dressing to existing products were it not for its uncontrollable leakage of exudate at the wound surface. The authors of this study sought to test a modified polyurethane dressing that expels controlled leakage into a second absorbent layer. In a randomized, comparative, double-blind study, the authors tested the efficacy of their modified polyurethane dressing against Aquacel. The primary outcome measurement was reepithelialization, and the secondary variables were pain, cost, and scarring.

Methods
Patient Profile This double-blind study was performed on 50 patients between June 2008 and June 2009. Patients required skin grafting either as a single procedure or in combination with other reconstructive surgery. 23 were men and 27 women, ranging from age 18 to 95 (mean age of 2 2 62.65 years). The donor-site dimension ranged from 90 to 732 cm , with a mean of 233 cm .

Skin Grafting Procedure All skin grafts had the same thickness of 0.012 inches and were taken from the same donor site: the anterolateral thigh of the patient. An air-driven Dermatome (Zimmer, Freiburg, Germany) was used to obtain the graft, and the donor site was immediately covered with a moist pack until the rest of the surgery was completed.

Application of the Dressing On each patient, the modified polyurethane dressing was adapted to fit over half the donor-site, and the Aquacel dressing was adapted to fit over the other half (Figure 1). Two layers of cotton gauze pads were placed over both the dressings to allow double-blind evaluation. The dressings were then left in place for 10 days, the maximum time expected for complete reepithelialization by Aquacel. The dressings were only removed if an infection was suspected, in which case the patient was additionally treated with an antimicrobial dressing and removed from the experiment. Evaluation of Reepithelialization and Local Pain After 10 days, reepithelialization was evaluated on each half of the donor sites in a blinded manner (Figure 2, Figure 3). Wounds were considered to have completely reepithelialized if there was no body exudate, and exposure to an antiseptic solution and air did not cause pain. Investigators had to mark whether each half of the donor site was completely reepithelialized or not, and compare which half was more complete. In addition, local pain was measured each postoperative day and during dressing removal using a pain scale of 0 (no pain) to 5 (maximal severe pain). Patients were asked to rate the pain at each half of the donor site, and compare which site inflicted more pain. Evaluation of Scarring 60 days after the surgery, scarring at the donor site was analyzed in a blinded fashion using the Vancouver Scar Scale.

Results
1. Polyurethane dressing exhibited higher rate of complete reepithelialization: 86.4% of the donor sites treated with the polyurethane completely reepithelialized, compared to 54.5% of the Aquacel-treated sites (p < 0.001). 2. Local pain was consistently low during healing: 90% of the values on the pain scale were less than or equal to 1. However, when asked to compare the two halves on the donor site, a significantly higher percentage rated the polyurethane dressing site to be less painful than the Aquacel site. This percentage increased over time (Figure 4), meaning that Aquacel was consistently rated more painful as day 10 approached. 3. Local pain was lower in polyurethane during removal: 59% of the patients rated the Aquacel site more painful than polyurethane during removal, whereas 6.8% rated the polyurethane removal more painful (p < 0.001). 4. Aquacel is 4 times more expensive than the polyurethane dressing: When compared to 2 a donor site of 8 x 20 cm , Aquacel dressing cost approximately four times more. 5. Limited scarring from both dressings: Both sites exhibited inconspicuous scarring, and no significant differences could be measured between dressings.

Discussion
This paper uses double-blind study to demonstrate that a modified polyurethane film is superior to a leading dressing (Aquacel) in that it better promotes complete reepithelialization, provides more patient comfort, and is less expensive. One thing the authors point out is that they did not use the same method for applying Aquacel as the method in another study that achieved complete reepithelialization in 7-10 days. While the other study used more than one layer of Aquacel and replaced the dressing as needed, this study used only one layer of Aquacel. This could account for both the poorer reepithelialization and increase in local pain, since Aquacel exhibits degradation over time. The authors argue that the replacement of a wound dressing exposes the

patient to potential infection, and when weighted against additional factors such as cost and labor, Aquacel is an inferior dressing. Nevertheless, this paper successfully demonstrates that a modified polyurethane film used with an absorbent layer is an effective wound dressing, and may very well be the next gold standard.

Figures & Controls Figure 1: Arrangement of dressings on donor sites Controls:

Aquacel dressing None Suggested: wound without dressing double-layered Aquacel from Barnea et al. protocol additional dressing products (e.g. BioBrane, Tegaderm, etc.)

Figure 2: Evaluation of Reepithelialization Controls:

Aquacel dressing None Suggested: wound without dressing double-layered Aquacel from Barnea et al. protocol additional dressing products (e.g. BioBrane, Tegaderm, etc.)

Figure 3: Evaluation of Reepithelialization Controls:

Aquacel dressing None Suggested: wound without dressing double-layered Aquacel from Barnea et al. protocol additional dressing products (e.g. BioBrane, Tegaderm, etc.)

Figure 4: Local Pain Comparison Controls:

None None Suggested: To ensure results are independent of the location of the site, polyurethane site and Aquacel site should be randomized (left or right side of the donor site) To ensure that results are independent of the order in which site the patient is asked about, investigators should randomize the order in which they reference each half on the donor site.

Figure 5: Pain evaluation during dressing removal Controls:

None None Suggested: Reference values: Tap on the arm Flick on the arm Pinch on the arm

Figure 6: Evaluation of scarring after 60 days Controls:

None None Suggested: Reference values: Image of no scarring Image depicting visible scarring

Critique
While most of the data is sound, some of the methods and results could have been elaborated. For example, the authors should also have tested the Barnea et al. protocol, in which Aquacel caused complete reepithelialized in 7-10 days. In the protocol, Aquacel was double-layered and replaced when soaked. This would have provided more insight into the efficacy of the modified polyurethane dressing compared to Aquacel in optimal conditions. It would also be ideal to test one dressing exclusively on each patient instead of both on the same donor site. This would ensure each dressing is acting alone without beneficial or diminutive effects of the other dressing crossing over. The pain evaluation system was not without flaws, either. The dressings should be randomly placed on either half of the donor site, and the order of scaffold removal should also be random. This will ensure that the location of the dressing or order in which it was removed does not bias the patient. In addition, investigators should randomize the order in which they address the pain from each dressing in order to remove the chance that patients are more likely to select one based on the order in which it was mentioned. The authors claimed that Aquacel was approximately 4 times more expensive than the polyurethane film, but did not support their conclusion with any data. They also did not mention whether they estimated the cost for each patient and came up with an average, or calculated the cost for only one case. A proper measurement for scarring was not detailed in the report. It would have been helpful to display a chart of Vancouver Scar Scale with examples of different values. Without this chart, there is no way to understand how little or how much scarring actually occurred. Lastly, the authors claim that the polyurethane film is suitable for use in donor sites up to 1050 2 2 cm , yet the largest donor site in the experiment was 732 cm .

Suggested Experiments
1.) Test multiple dressings, each isolated and randomly placed on a separate donor site. In addition to Aquacel, the polyurethane film should be compared to a negative control of just gauze, as well as other dressings such as BioBrane and TegaDerm. Each dressing should be tested using optimal methods, and evaluated after 10 days.

Controls:
Gauze Aquacel TegaDerm

Each donor site will be separate from one another. Dressings will be randomly placed on one of the 4 donor sites.

2.) Set standards for daily pain evaluation. Before obtaining a pain score from 0 to 5 for the donor sites, obtain a score for the following: Tap on the arm Flick on the arm Pinch on the arm Additionally, collect data to determine whether a particular donor site consistently yielded a higher pain score. 3.) Test the limits of the polyurethane film. 2 Test larger donor-site size to prove viability for donor sites up to 1050cm or larger. Measure complete reepithelialization after 10 days.

Controls:
Dressing known to work at 2 1050 cm

732 cm

900 cm

1050 cm

Polyurethane Film Dressing

732 cm

900 cm

1050 cm

Dressing known to cause complete reepithelialization at 1050 cm

4.) Compare total cost of each dressing. For each patient, calculate the total surgical and post-operative costs within 60 days of treatment for each dressing. Determine the average cost per area of donor site.

Controls:
Aquacel TegaDerm

References Original Article: http://www.ncbi.nlm.nih.gov/pubmed/21681125