Ignite Creation Date:
2025-12-25 @ 3:56 AM
Ignite Modification Date:
2025-12-26 @ 2:47 AM
Study NCT ID:
NCT04765202
Status:
TERMINATED
Last Update Posted:
2025-05-16
First Post:
2021-02-04
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
StrataGraft Overlay of Meshed Autograft in Full-thickness Thermal Burns
Sponsor:
Stratatech, a Mallinckrodt Company
Organization:
Study Overview
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
Status:
TERMINATED
Status Verified Date:
2025-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Business Reason
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
StrataSOMA
Brief 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.
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: