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StrataGraft Overlay of Meshed Autograft in Full-thickness Thermal Burns

NCT04765202 · Status: TERMINATED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 13

Last updated 2025-05-16

Study results available
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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

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.

Sponsors & Collaborators

  • Stratatech, a Mallinckrodt Company

    lead INDUSTRY

Principal Investigators

  • Clinical Team Leader · Stratatech, a Mallinckrodt Company

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-10-10
Primary Completion
2024-06-07
Completion
2024-06-07
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04765202 on ClinicalTrials.gov