Phase III Multicenter Study Evaluating denovoSkin12 Autologous Skin Graft Versus Standard Skin Graft for Treating Deep Partial and Full-Thickness Burns in Adolescents and Adults

What this Trial Is About

Researchers are conducting a multicentre phase III clinical trial involving adults and adolescents aged 12 years and older who have severe burns. The study aims to confirm the effectiveness and function of denovoSkin, an autologous dermo-epidermal skin substitute, in achieving wound closure and reducing scarring for patients with deep partial and full-thickness burns compared to the standard treatment of split-thickness skin grafts. Participants receive either the experimental treatment with denovoSkin applied to one burn area or the standard split-thickness skin graft STSG applied to another area. The study uses an intra-patient randomized design where one location is treated with denovoSkin and the other with STSG, with the roles of locations A and B switched among participants. This design allows direct comparison of the two treatments in the same patient. During the trial, participants are monitored for wound closure and scar quality six months after grafting, which is the primary outcome. Secondary outcomes include assessment of graft take, epithelialization, scar contracture, and donor site healing at various time points up to 24 months post-grafting. Participants will undergo regular evaluations to measure these outcomes and ensure safety, with the study lasting until 2029.

Phase III Study With an Autologous Dermo-epidermal Skin Substitute for the Treatment of Burns in Adults and Adolescents