Burns : journal of the International Society for Burn Injuries · 2026
PermeaDerm accelerates early wound healing in partial-thickness burns: A multicenter randomized controlled trial.
СтатьяРандомизированное исследованиеМногоцентровое исследованиеНазвание и аннотация: Перевод в очереди
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Tang Hongtai, Chu Guoping, Xiang Jun, Shi Yan, Liu Shuhua, Wu Wenfeng, Xie Weiguo, Liu Yan, Lv Guozhong, Xia Zhaofan
Аннотация
BACKGROUND: 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.
METHODS: 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.
RESULTS: 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.
CONCLUSION: 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.
METHODS: 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.
RESULTS: 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.
CONCLUSION: 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.