NCT04765202

StrataGraft Overlay of Meshed Autograft in Full-thickness Thermal Burns

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

• Status: Terminated
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 13 (actual)
• Sponsor: Stratatech, a Mallinckrodt Company · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Autografting is a surgical procedure to transplant healthy skin (donor skin) from another part of the participant'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 received meshed autograft on one part of their burn (AG Tx). They received more widely meshed than AG Tx site autograft with a StrataGraft covering (SOMA Tx) on a different part of their burn.

Conditions

• Full Thickness Thermal Burn

Interventions

Type	Name	Description
PROCEDURE	AG Tx	Control treatment that is meshed autograft alone applied to a burn area.
BIOLOGICAL	SOMA Tx	Meshed autograft applied to the burn area and covered with StrataGraft.

Timeline

• Start date: 2021-10-10
• Primary completion: 2024-06-07
• Completion: 2024-06-07
• First posted: 2021-02-21
• Last updated: 2025-05-16
• Results posted: 2025-05-16

Locations

5 sites across 1 country: United States

Regulatory

• FDA-regulated drug study