Ignite Creation Date:
2024-05-06 @ 3:49 PM
Last Modification Date:
2024-10-26 @ 1:57 PM
Study NCT ID:
NCT04765202
Status:
COMPLETED
Last Update Posted:
2024-06-27
First Post:
2021-02-04
Brief Title:
StrataGraft Overlay of Meshed Autograft in Full-thickness Thermal Burns
Sponsor:
Stratatech a Mallinckrodt Company
Organization:
Mallinckrodt
Study Overview
Official Title:
A Phase 12a 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:
COMPLETED
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
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 patients 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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
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?:
None