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 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.

Study Overview

• Status: Active, not recruiting
• Conditions: Full Thickness Thermal Burn
• Intervention / Treatment: Procedure: AG Tx; Biological: SOMA Tx

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

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 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: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: All participants; 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; The control treatment is meshed autograft applied to a FT burn area; Other Names: Meshed Autograft; Biological: SOMA Tx; The experimental treatment is more widely meshed autograft than the AG Tx site applied to a FT burn area and covered with SOMA; 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

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): May 28, 2021
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): December 1, 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): March 20, 2024
• Last Update Submitted That Met QC Criteria: March 19, 2024
• Last Verified: March 1, 2024

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