Full Thickness Thermal Burn Clinical Trial
Official title:
A Phase 1/2a, Controlled, Randomized, Multicenter Study Evaluating the Efficacy, Safety, and Tolerability of StrataGraft Overlay of Meshed Autograft (SOMA) in Treatment of Full-Thickness Thermal Burns
Autografting is a surgical procedure to transplant healthy skin (donor skin) from another part of the patient's own body (donor site) to the burned part. Autografting is the usual treatment for full-thickness (FT) burns. It works to close the wound, but can cause other problems: - Donor sites are painful, can become infected or scarred, or can even become FT wounds themselves - Treatment problems can require more grafting - Additional surgery increases risk of medical problems caused by the treatment Stratatech is trying to find a safe and effective treatment option for severe burns that uses less donor skin. All participants in this study will receive meshed autograft on one part of their burn (AG Tx). They will receive more widely meshed than AG Tx site autograft with a StrataGraft covering (SOMA Tx) on a different part of their burn. Each participant will be involved in the study up to about 14 months.
n/a