Full Thickness Thermal BurnPhase 1/2StrataSOMANCT04765202
StrataGraft Overlay of Meshed Autograft in Full-thickness Thermal Burns
A Phase 1/2 study testing AG Tx and SOMA Tx in people with Full Thickness Thermal Burn, run by Stratatech, a Mallinckrodt Company at 5 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Full Thickness Thermal Burn
- What is being tested?
- AG Tx and SOMA Tx
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 5 sitesUnited States
- Study dates
- 10 Oct 2021to 7 Jun 2024
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Medical University of South Carolina
Charleston, South Carolina, 29425
University of Iowa Hospitals and Clinics
Iowa City, Iowa, 52242
Stony Brook University
Stony Brook, New York, 11794
Tampa General Hospital / University of South Florida
Tampa, Florida, 33606
Medstar Washington Hospital Center
Washington D.C., District of Columbia, 20010
About this study
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
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:
Read more
- 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
- Being tested
- AG Tx, SOMA Tx
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AG TxProcedure or surgery
Also called Meshed Autograft
Control treatment that is meshed autograft alone applied to a burn area.
SOMA TxBiological
Also called StrataGraft skin tissue Overlay of Meshed Autograft (SOMA)
Meshed autograft applied to the burn area and covered with StrataGraft.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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. Receives: Biological: SOMA Tx |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: At Month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2021
- Study start10 Oct 2021
- Primary completion7 Jun 2024
- Study completion7 Jun 2024
Why it stopped: Business Reason
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Full Thickness Thermal BurnStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stratatech, a Mallinckrodt Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Team Leader, Study director, Stratatech, a Mallinckrodt Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04765202
- Sponsor's protocol ID
- MNK01062117
- Acronym
- StrataSOMA
- Status last verified
- May 2025
- First submitted
- 4 Feb 2021
- Last updated
- 16 May 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04765202
- Acronym / sponsor ID
- StrataSOMA / MNK01062117
- Conditions
- Full Thickness Thermal Burn
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Business Reason
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Stratatech, a Mallinckrodt CompanyIndustry (pharma, biotech, devices)
- Study start
- 10 Oct 2021 (actual)
- Primary completion
- 7 Jun 2024 (actual)
- Study completion
- 7 Jun 2024 (actual)
- First posted
- 21 Feb 2021 (actual)
- Results
- Posted 16 May 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Cohort1 Group1: AG Tx Sites | Experimental | Procedure: AG TxParticipants received autograft treatment (AG Tx) consisting of autograft alone (mesh ratio "m", per clinical judgment) at the treatment site on Day 1. |
| Cohort1 Group1: SOMA Tx Sites | Experimental | Biological: SOMA TxParticipants 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. |
| Cohort1 Group 2: AG Tx Sites | Experimental | Procedure: AG TxParticipants received AG Tx consisting of autograft alone (mesh ratio "m", per clinical judgment) at the treatment site on Day 1. |
| Cohort1 Group2: SOMA Tx Sites | Experimental | Biological: SOMA TxParticipants 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AG TxAlso: Meshed AutograftControl treatment that is meshed autograft alone applied to a burn area. | Procedure or surgery | Cohort1 Group 2: AG Tx Sites, Cohort1 Group1: AG Tx Sites |
| SOMA TxAlso: StrataGraft skin tissue Overlay of Meshed Autograft (SOMA)Meshed autograft applied to the burn area and covered with StrataGraft. | Biological | Cohort1 Group1: SOMA Tx Sites, Cohort1 Group2: SOMA Tx Sites |
Primary outcome
Number of Treatment Sites With Complete Wound Closure Without Additional Autografting at Month 2
Time frame: 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.
Number of Participants With Durable Wound Closure of Study Treatment Sites Without Additional Autografting at Month 12
Time frame: At Month 12
Durable wound closure is defined as persistence of closure, maintained for at least 3 months after the initial observation of closure.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Team Leader study director
Stratatech, a Mallinckrodt Company
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing AG Tx and SOMA Tx in people with Full Thickness Thermal Burn, run by Stratatech, a Mallinckrodt Company at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 16 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 16 May 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Treatment Sites With Complete Wound Closure Without Additional Autografting at Month 2 (time frame: At Month 2). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2025.