StrataGraft Overlay of Meshed Autograft in Full-thickness Thermal Burns

NCT04765202 | Terminated Phase 1 Results DMC FDA Drug

• 1 other identifier: MNK01062117
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 5

Brief 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

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (4)

Cohort1 Group1: AG Tx Sites

EXPERIMENTAL

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

Cohort1 Group1: SOMA Tx Sites

EXPERIMENTAL

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

Cohort1 Group 2: AG Tx Sites

EXPERIMENTAL

Participants received AG Tx consisting of autograft alone (mesh ratio "m", per clinical judgment) at the treatment site on Day 1.

Procedure: AG Tx

Cohort1 Group2: SOMA Tx Sites

EXPERIMENTAL

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

Interventions

AG Tx PROCEDURE

Control treatment that is meshed autograft alone applied to a burn area.

Also known as: Meshed Autograft

Cohort1 Group 2: AG Tx Sites; Cohort1 Group1: AG Tx Sites

SOMA Tx BIOLOGICAL

Meshed autograft applied to the burn area and covered with StrataGraft.

Also known as: StrataGraft skin tissue Overlay of Meshed Autograft (SOMA)

Cohort1 Group1: SOMA Tx Sites; Cohort1 Group2: SOMA Tx Sites

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Stratatech, a Mallinckrodt Company: lead

Study Sites (5)

Medstar Washington Hospital Center

Washington D.C., District of Columbia, 20010, United States

Location

Tampa General Hospital / University of South Florida

Tampa, Florida, 33606, United States

Location

University of Iowa Hospitals and Clinics

Iowa City, Iowa, 52242, United States

Location

Stony Brook University

Stony Brook, New York, 11794, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

Results Point of Contact

• Title: Medical Information Call Center
• Organization: Mallinckrodt

medinfo@mnk.com

800-844-2830

Study Officials

• Clinical Team Leader

  Stratatech, a Mallinckrodt Company

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 4, 2021
• First Posted: February 21, 2021
• Study Start: October 10, 2021
• Primary Completion: June 7, 2024
• Study Completion: June 7, 2024
• Last Updated: May 16, 2025
• Results First Posted: May 16, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (5)