drugset
drugset / Trial / NCT04765202

StrataGraft Overlay of Meshed Autograft in Full-thickness Thermal Burns

NCT04765202 ↗

Phase 1/2 Terminated 13 enrolled Stratatech, a Mallinckrodt Company
RandomizedSingle-groupOpen-labelTreatment

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.

Timeline

Start
2021-10-10
Primary completion
2024-06-07
Completion
2024-06-07

Outcome

Missed primary endpoint

Stopped (Business): “Business Reason”

registry analysis (superiority test); Cohort1 Group1: AG Tx vs Cohort1 Group1: SOMA Tx; p = 1.0000 NCT04765202 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject StrataGraft Other / unclassified — —

Indications

No indication recorded.