TerminatedNCT04765202StrataSOMAUpdated May 16, 2025Results posted

StrataGraft Overlay of Meshed Autograft in Full-thickness Thermal Burns

A Phase 1/2 interventional study of AG Tx and SOMA Tx in Full Thickness Thermal Burn, sponsored by Stratatech, a Mallinckrodt Company. Terminated at 5 sites in United States. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2025-05-16.

Sponsored by Stratatech, a Mallinckrodt Company · Phase 1/2, Interventional, and Treatment

Why this study was terminated

Business Reason

Phase: Phase 1/2
Study type: Interventional
Enrollment: 13
Allocation: Randomized
Ages: 18 Years to 75 Years
Sex: All

Study 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 studied

Full Thickness Thermal Burn

Browse trials for

Burns 719

In context

Burns

719 studies on the registry are indexed under Burns; 145 are open to participants now.

This study's enrollment of 13 is below the median of 40 across 524 interventional studies indexed under Burns.

Browse Burns studies →

Lead sponsor

Stratatech, a Mallinckrodt Company is the lead sponsor of 9 studies on the registry; none are open to participants now.

Of its 7 completed or terminated interventional studies of FDA-regulated products, 5 (71%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 75 Years
Sexes eligible: All
Accepts healthy volunteers: No

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

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 design

Phase: Phase 1 / Phase 2
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Single group
Masking: None (open label)
Enrollment: 13 participants (actual)

Study arms

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
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
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
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

Interventions

ProcedureAG Tx
Control treatment that is meshed autograft alone applied to a burn area.
Also known as: Meshed Autograft
BiologicalSOMA Tx
Meshed autograft applied to the burn area and covered with StrataGraft.
Also known as: StrataGraft skin tissue Overlay of Meshed Autograft (SOMA)

What researchers measure

Primary outcomes

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.
Time frame: 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.
Time frame: At Month 12

Results

Posted May 16, 2025

Participant flow

Participants took part in the study at 5 investigative sites in the United States from 10 October 2021 to 07 June 2024.

Participant flow — Overall Study
Milestone	Cohort1 Group1: AG Tx	Cohort1 Group1: SOMA Tx	Cohort1 Group2: AG Tx	Cohort1 Group2: SOMA Tx
Started	7	7	6	6
Completed	6	6	3	3
Not completed	1	1	3	3
Withdrew: Lost to follow-up	1	1	2	2
Withdrew: Physician decision	0	0	1	1

Outcome measures

PrimaryNumber 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.

Time frame:: At Month 2
Reported as:: Number · treatment sites

Number of Treatment Sites With Complete Wound Closure Without Additional Autografting at Month 2
treatment sites	Cohort1 Group1: AG Tx	Cohort1 Group1: SOMA Tx	Cohort1 Group2: AG Tx	Cohort1 Group2: SOMA Tx
Number of Treatment Sites With Complete Wound Closure Without Additional Autografting at Month 2	6	7	6	6

Statistical analysis

Cohort1 Group1: AG Tx vs Cohort1 Group1: SOMA Tx · Fisher Exact · p = 1.0000 · Percentage difference: 14.3 · 95% CI -11.64 to 40.21Difference was calculated as (percent area of wound closure in SOMA Tx site) - ((percent area of wound closure in AG Tx site). 95% CI was derived using the normal approximation to binomial distribution.
Cohort1 Group2: AG Tx vs Cohort1 Group2: SOMA Tx · Percentage difference: 0 · 95% CI 0 to 0Difference was calculated as (percent area of wound closure in SOMA Tx site) - ((percent area of wound closure in AG Tx site). 95% CI was derived using the normal approximation to binomial distribution.

PrimaryNumber 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.

Time frame:: At Month 12
Reported as:: Count of participants · Participants

Number of Participants With Durable Wound Closure of Study Treatment Sites Without Additional Autografting at Month 12
Participants	Cohort 1 Group 1	Cohort 1 Group 2
AG Tx Site	6	3
SOMA Tx Site	6	3

Adverse events

Collected over Up to 13 months. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Cohort 1 Group 1: All Participants	0/7 (0%)	1/7 (14.3%)	7/7 (100%)
Cohort 1 Group 1: AG Tx Sites	0/7 (0%)	0/7 (0%)	3/7 (42.9%)
Cohort 1 Group 1: SOMA Tx Sites	0/7 (0%)	0/7 (0%)	1/7 (14.3%)
Cohort 1 Group 2: All Participants	0/6 (0%)	1/6 (16.7%)	6/6 (100%)
Cohort 1 Group 2: AG Tx Sites	0/6 (0%)	0/6 (0%)	3/6 (50%)
Cohort 1 Group 2: SOMA Tx Sites	0/6 (0%)	0/6 (0%)	3/6 (50%)

Most frequent serious events

Most frequent serious events
Event	Cohort 1 Group 1: All Participants	Cohort 1 Group 1: AG Tx Sites	Cohort 1 Group 1: SOMA Tx Sites	Cohort 1 Group 2: All Participants	Cohort 1 Group 2: AG Tx Sites	Cohort 1 Group 2: SOMA Tx Sites
Pulmonary embolismRespiratory, thoracic and mediastinal disorders	0/7	0/7	0/7	1/6	0/6	0/6
Homicidal ideationPsychiatric disorders	1/7	0/7	0/7	0/6	0/6	0/6
Suicidal ideationPsychiatric disorders	1/7	0/7	0/7	0/6	0/6	0/6
Deep vein thrombosisVascular disorders	1/7	0/7	0/7	0/6	0/6	0/6

Most frequent other events

Showing 10 of 35

Most frequent other events
Event	Cohort 1 Group 1: All Participants	Cohort 1 Group 1: AG Tx Sites	Cohort 1 Group 1: SOMA Tx Sites	Cohort 1 Group 2: All Participants	Cohort 1 Group 2: AG Tx Sites	Cohort 1 Group 2: SOMA Tx Sites
Hypertrophic scarSkin and subcutaneous tissue disorders	1/7	1/7	1/7	2/6	2/6	2/6
ConstipationGastrointestinal disorders	2/7	0/7	0/7	0/6	0/6	0/6
PruritusSkin and subcutaneous tissue disorders	2/7	2/7	1/7	1/6	1/6	1/6
PainGeneral disorders	1/7	0/7	0/7	1/6	0/6	0/6
NauseaGastrointestinal disorders	0/7	0/7	0/7	1/6	0/6	0/6
VomitingGastrointestinal disorders	0/7	0/7	0/7	1/6	0/6	0/6
AbscessInfections and infestations	0/7	0/7	0/7	1/6	0/6	0/6
COVID-19Infections and infestations	0/7	0/7	0/7	1/6	0/6	0/6
Staphylococcal skin infectionInfections and infestations	0/7	0/7	0/7	1/6	0/6	0/6
Wound infectionInfections and infestations	0/7	0/7	0/7	1/6	0/6	0/6

Baseline characteristics

The Full Analysis Set (FAS) included all participants who were randomized and treated with at least one area of SOMA Tx and one area of AG Tx.

Age, Continuous
Age, Continuous(years)	Cohort 1 Group 1	Cohort 1 Group 2	Total
Mean	47.4 ± 12.20	47.2 ± 12.54	47.3 ± 11.83

Sex: Female, Male
Sex: Female, Male(Participants)	Cohort 1 Group 1	Cohort 1 Group 2	Total
Female	0	2	2
Male	7	4	11

Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)	Cohort 1 Group 1	Cohort 1 Group 2	Total
Hispanic or Latino	2	2	4
Not Hispanic or Latino	5	4	9
Unknown or Not Reported	0	0	0

Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)	Cohort 1 Group 1	Cohort 1 Group 2	Total
White	4	4	8
Black or African American	1	0	1
Not Reported	1	2	3
Other	1	0	1

Study locations

5 sites

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

References and documents

Study documents

Study protocol · Sep 28, 2023
Statistical analysis plan · Jul 26, 2024

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on May 16, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT04765202
Lead sponsor: Stratatech, a Mallinckrodt Company
Responsible party: Sponsor
First posted: Feb 21, 2021
Start date: Oct 10, 2021
Primary completion: Jun 7, 2024
Completion: Jun 7, 2024
Results posted: May 16, 2025
Last update: May 16, 2025

Study contacts

Clinical Team Leader

study director · Stratatech, a Mallinckrodt Company

Oversight

Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

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