StrataGraft Overlay of Meshed Autograft in Full-thickness Thermal Burns

Study Overview
=================
Brief Summary
-----------------
Autografting is a surgical procedure to transplant healthy skin (donor skin) from another part of the patient'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 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.

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

Conditions
-----------------
Full Thickness Thermal Burn

Intervention / Treatment
-----------------
* Procedure: AG Tx
* Biological: SOMA Tx


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Has 2% to 49% (inclusive) total body surface area (TBSA) thermal burn area, including areas of FT injury clinically indicated for surgical excision and autografting, appropriate for protocol-defined treatment areas Meets protocol-specified criteria for qualification and contraception Is willing and able to comply with all study procedures and requirements Voluntarily consents to participate and provides written informed consent prior to any protocol-specific procedures Exclusion Criteria: Is a prisoner, pregnant, or had previous autografting to treatment sites Is expected to survive less than 3 months Is participating in another interventional trial, or did within 30 days before enrollment Has anticipated treatment sites that are outside protocol-specified parameters Has concurrent clinically significant inhalation injury, inadequate fluid resuscitation, or burns of chemical or electrical (non-thermal) etiology Has other signs, symptoms or history of any condition that, per protocol or in the opinion of the investigator, might compromise: the safety or well-being of the participant the study objectives

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Within-patient controlled - treatment sites on the same patient are randomized to be test or control This means each participant receives both study treatments and serves as their own control.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: All participants<br>Each participant will receive both treatments. On each participant, similar wounds will be identified as treatment sites. Treatment sites will be randomized to receive either AG Tx (control) or SOMA Tx (experimental). | Procedure: AG Tx<br>* The control treatment is meshed autograft applied to a FT burn area<br>* Other names: Meshed Autograft;Biological: SOMA Tx<br>* The experimental treatment is more widely meshed autograft than the AG Tx site applied to a FT burn area and covered with SOMA<br>* Other names: StrataGraft skin tissue Overlay of Meshed Autograft (SOMA);|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Treatment Sites with Complete Wound Closure Without Additional Autografting at Month 2 | Complete wound closure is defined as complete skin re-epithelialization without drainage confirmed at 2 visits at least 2 weeks apart, and no later than Week 20. | At Month 2 | 
| Number of Participants with Durable Wound Closure of the Study Treatment Sites Without Additional Autografting at Month 12 | Durable wound closure is defined as persistence of closure, maintained for at least 3 months after the initial observation of closure. | At Month 12 |