StrataGraft Overlay of Meshed Autograft in Full-thickness Thermal Burns (StrataSOMA)

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

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.

Study Overview

• Status: Terminated
• Conditions: Full Thickness Thermal Burn
• Intervention / Treatment: Procedure: AG Tx; Biological: SOMA Tx

• Study Type: Interventional
• Enrollment (Actual): 13
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• United States
  • District of Columbia
    • Washington, District of Columbia, United States, 20010
      • Medstar Washington Hospital Center
  • Florida
    • Tampa, Florida, United States, 33606
      • Tampa General Hospital / University of South Florida
  • Iowa
    • Iowa City, Iowa, United States, 52242
      • University of Iowa Hospitals and Clinics
  • New York
    • Stony Brook, New York, United States, 11794
      • Stony Brook University
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Medical University of South Carolina

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Has 2% to 49% (inclusive) total body surface area (TBSA) thermal burn area, including areas of full thickness (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:

  1. The safety or well-being of the participant
  2. The study objectives

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cohort1 Group1: AG Tx Sites; Participants received autograft treatment (AG Tx) consisting of autograft alone (mesh ratio "m", per clinical judgment) at the treatment site on Day 1.	Procedure: AG Tx; Control treatment that is meshed autograft alone applied to a burn area.; Other Names: Meshed Autograft
Experimental: Cohort1 Group1: SOMA Tx Sites; Participants received StrataGraft overlay of meshed autograft (SOMA Tx) at the treatment site in which m+1:1 meshed autograft was overlaid with StrataGraft, and applied to wounds of 100 to 400 square centimeters (cm^2) in area on Day 1.	Biological: SOMA Tx; Meshed autograft applied to the burn area and covered with StrataGraft.; Other Names: StrataGraft skin tissue Overlay of Meshed Autograft (SOMA)
Experimental: Cohort1 Group 2: AG Tx Sites; Participants received AG Tx consisting of autograft alone (mesh ratio "m", per clinical judgment) at the treatment site on Day 1.	Procedure: AG Tx; Control treatment that is meshed autograft alone applied to a burn area.; Other Names: Meshed Autograft
Experimental: Cohort1 Group2: SOMA Tx Sites; Participants received SOMA Tx on the treatment site in which m+2:1 meshed autograft was overlaid with StrataGraft, and applied to wounds of 100 to 400 cm^2 in area on Day 1.	Biological: SOMA Tx; Meshed autograft applied to the burn area and covered with StrataGraft.; 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	Confirmed complete wound closure was defined as complete skin re-epithelialization without drainage confirmed at 2 visits at least 2 weeks apart but no later than Week 20. Complete wound closure was considered to have occurred at the earlier of the 2 observations of complete skin re-epithelialization without drainage. The number of treatment sites with complete wound closure without additional autografting at Month 2 was reported.	At Month 2
Number of Participants With Durable Wound Closure of 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

Collaborators and Investigators

• Sponsor: Stratatech, a Mallinckrodt Company
• Investigators: Study Director: Clinical Team Leader, Stratatech, a Mallinckrodt Company

Study record dates

Study Major Dates

• Study Start (Actual): October 10, 2021
• Primary Completion (Actual): June 7, 2024
• Study Completion (Actual): June 7, 2024

Study Registration Dates

• First Submitted: February 4, 2021
• First Submitted That Met QC Criteria: February 18, 2021
• First Posted (Actual): February 21, 2021

Study Record Updates

• Last Update Posted (Actual): May 16, 2025
• Last Update Submitted That Met QC Criteria: May 15, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Burns; Physiological Effects of Drugs; Peripheral Nervous System Agents; Neuromuscular Agents; Muscle Relaxants, Central; Carisoprodol
• Other Study ID Numbers: MNK01062117

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No