A Randomized, Controlled Trial Comparing PermeaDerm to Mepilex Ag for the Treatment of Adult and Pediatric Partial-Thickness Burns.

Abstract

A next-generation transparent biosynthetic wound matrix (PermeaDerm) was developed for the treatment of burn injuries. Improvements include slits in an outer 2D silicone epidermal analog allowing for customizable moisture control, and an updated biocoating of the nylon knitted fabric to optimize wound adherence. The purpose of this randomized, single-blinded, multicenter trial was to compare PermeaDerm to a commonly used silver-containing foam dressing (Mepilex Ag) for the treatment of partial-thickness burns. Patients with partial-thickness burns <30% TBSA treated within 72 hours were included. Primary outcomes included incidence of 100% re-epithelialization at 14 days and time to conversion to alternative therapy. Secondary outcomes included incidence of healing at 7 and 21 days, pain, number of product changes, and adverse events. Sixty-seven patients (42 pediatric, 25 adult) were analyzed, 32 with Mepilex Ag and 35 with PermeaDerm. Though not statistically significant, more patients achieved healing with PermeaDerm at day 14 (P = 0.36), particularly those with superficial partial-thickness injuries (OR 5.87, P = 0.203, 95% CI = 0.385, 89.580). This trend continued to day 21 (P = 0.25). At day 7, nonsignificant increased incidence of healing of Mepilex Ag-treated wounds was observed (P = 0.25), in addition, PermeaDerm was associated with lower needs for product changes (OR 0.15, P = 0.034, 95% CI = 0.027, 0.872); both observations likely attributable to the adherent nature of PermeaDerm. No significant differences in time to conversion to alternate therapies were noted. Overall pain scores, aesthetics, and adverse events, including infection, were similar between groups. PermeaDerm is a safe and effective treatment for partial-thickness burns. PermeaDerm offers the clinical advantages of being transparent to continuously monitor the wound and adherent, reducing the need for a product change and allowing for bathing after 72 hours.