A Prospective Non-Inferiority Randomized Controlled Trial to Evaluate the Effectiveness of a Five-Layer Polyurethane Foam Dressing for Wound Healing
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Purpose: The purpose of this study was to examine wound healing of acute and chronic wounds by comparing two five-layer polyurethane foam dressings. Objectives: 1) Compare the changes in surface area for wounds treated with two different five-layer polyurethane foam dressings. 2) Compare the characteristics of wounds treated with two different types of five-layer polyurethane foam dressings. Methods: A non-inferiority, pragmatic, open-label randomized controlled trial was conducted to explore the hypothesis that one five-layer foam dressing (Optifoam® Adhesive) is no less effective than another five-layer foam dressing (Mepilex® Border). Changes in wound surface area and in wound characteristics were assessed weekly for up to four weeks by calculating the decrease in wound surface area and completing a wound assessment tool. Results: An initial sample size of 50 was calculated. Over an eight-month period, 18 participants were recruited from three different sites. Wounds in the Optifoam® group had a statistically significant faster decrease in wound surface area than wounds in the Mepilex® group: 0.96 cm2 per day compared to 0.26 cm2 per day (p = 0.004). The mean BWAT score for participants in the Mepilex® group was 24.1 (SD 6.6) and 24.5 (SD 6.1) in the Optifoam® group. This difference was within the non-inferiority limit that was set a priori. There were 18 participants enrolled in the study, only 5 participants completed all four weeks of the study. Due to the recruitment and retention issues, feasibility issues of conducting this research were also addressed. Conclusion: Based on the results of this study, Optifoam® is not inferior to Mepilex® Border. More research is needed with adequate sample size to support these results.