PermeaDerm accelerates early wound healing in partial-thickness burns: A multicenter randomized controlled trial

This multicenter, randomized controlled trial evaluated the safety and efficacy of PermeaDerm, a biosynthetic wound matrix, compared to porcine acellular dermal matrix (ADM) for the treatment of partial-thickness burns in Chinese patients.

A total of 184 patients were enrolled and randomized 1:1 to receive either PermeaDerm or ADM across the four Chinese centers. The primary endpoint was the proportion of wounds that achieved complete re-epithelialization by day 14 (superficial partial-thickness burns) or 21 (deep partial-thickness burns). The secondary endpoints included complete re-epithelialization over time, wound area reduction rate (cm²/day), time to complete re-epithelialization, pain scores, device performance, and incidence of complications.

PermeaDerm was non-inferior to ADM for the primary endpoint. On day 7, significantly more wounds treated with PermeaDerm achieved early complete re-epithelialization for superficial partial-thickness burns (55.6% [20/36] vs. 27.0% [10/37], p = 0.012) and deep partial-thickness burns (37.2% [19/51] vs. 12.7% [7/55], p = 0.005). The median wound area reduction rate at day 7 was also significantly higher with PermeaDerm for both superficial partial-thickness burns (2.41 cm²/day (IQR 0.86-5.07) vs. 1.05 cm²/day (IQR 0.34-3.01), p = 0.034) and deep partial-thickness burns (3.50 cm²/day (IQR 1.40-8.02) vs. 1.78 cm²/day (IQR 0.85-4.40), p = 0.021). After day 7, the healing rates were comparable between the groups. Median time to complete re-epithelialization was 3 days shorter with PermeaDerm for both superficial (7.00 days (IQR 6-10.25) vs. 10.00 days (IQR 7-12.75), p = 0.016) and deep partial-thickness burns (10.00 days (IQR 7-13) vs. 13.00 days (IQR 10-15), p = 0.003). Pain scores and complication rates were similar between the groups, while PermeaDerm was associated with more favorable ease of application, wound visibility, and removal.

PermeaDerm accelerates early wound healing and shortens the time to complete re-epithelialization compared with ADM, while maintaining a comparable safety profile. These findings suggest that PermeaDerm may represent a clinically useful alternative for the management of partial-thickness burns.