StrataGraft Overlay of Meshed Autograft in Full-thickness Thermal Burns (StrataSOMA)
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT04765202 |
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Recruitment Status :
Recruiting
First Posted : February 21, 2021
Last Update Posted : May 24, 2023
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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 meshed 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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Full Thickness Burn | Procedure: AG Tx Biological: SOMA Tx | Phase 2 |
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 40 participants |
| Allocation: | N/A |
| Intervention Model: | Single Group Assignment |
| Intervention Model Description: | Within-patient controlled - treatment sites on the same patient are randomized to be test or control This means each participant receives both study treatments and serves as their own control. |
| Masking: | None (Open Label) |
| Masking Description: | While the treatment itself is open label, the outcomes assessor will not know the treatment applied to each treatment site until after assessing the outcomes. |
| Primary Purpose: | Treatment |
| Official Title: | A Phase 1/2a, Controlled, Randomized, Multicenter Study Evaluating the Efficacy, Safety, Tolerability of StrataGraft Overlay of Meshed Autograft (SOMA) in Treatment of Full-Thickness Thermal Burns |
| Actual Study Start Date : | May 28, 2021 |
| Estimated Primary Completion Date : | January 2024 |
| Estimated Study Completion Date : | January 2024 |
| Arm | Intervention/treatment |
|---|---|
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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 Name: Meshed Autograft Biological: SOMA Tx The experimental treatment is meshed autograft applied to a FT burn area and covered with SOMA
Other Name: StrataGraft skin tissue Overlay of Meshed Autograft (SOMA) |
- Number of treatment sites with complete wound closure without additional autografting at Month 2 [ Time Frame: at Month 2 ]Complete wound closure is defined as complete skin re-epithelialization without drainage confirmed at 2 visits at least 2 weeks apart.
- Number of subjects with durable wound closure of the 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.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years to 75 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | 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:
- Is a prisoner, pregnant, or had previous treatment of the burn 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
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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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04765202
| United States, District of Columbia | |
| Medstar Washington Hospital Center | Recruiting |
| Washington, District of Columbia, United States, 20010 | |
| Contact: Principal Investigator 202-877-7347 jeffrey.w.shupp@medstar.net | |
| United States, Florida | |
| UF Health Burn Center at the University of Florida | Withdrawn |
| Gainesville, Florida, United States, 32610 | |
| Tampa General Hospital / University of South Florida | Recruiting |
| Tampa, Florida, United States, 33606 | |
| Contact: Site Coordinator 813-844-7873 mjung4@usf.edu | |
| United States, Iowa | |
| University of Iowa Hospitals and Clinics | Recruiting |
| Iowa City, Iowa, United States, 52242 | |
| Contact: Principal Investigator 319-356-3551 lucy-wibbenmeyer@uiowa.edu | |
| United States, Kansas | |
| University of Kansas Medical Center Research Institute, Inc. | Withdrawn |
| Kansas City, Kansas, United States, 66160 | |
| United States, Louisiana | |
| Baton Rouge General Medical Center | Withdrawn |
| Baton Rouge, Louisiana, United States, 70809 | |
| United States, Minnesota | |
| Health Partners Institute | Recruiting |
| Bloomington, Minnesota, United States, 55455 | |
| Contact: Principal Investigator 651-254-1532 sam.a.miotke@healthpartners.com | |
| United States, Missouri | |
| University of Missouri Health Care | Withdrawn |
| Columbia, Missouri, United States, 65212 | |
| United States, New York | |
| Stony Brook University | Recruiting |
| Stony Brook, New York, United States, 11794 | |
| Contact: Principal Investigator 631-624-7101 adam.singer@stonybrookmedicine.edu | |
| United States, North Carolina | |
| Wake Forest Baptist Medical Center Burn Center | Recruiting |
| Winston-Salem, North Carolina, United States, 27157 | |
| Contact: Site Coordinator 336-716-4278 cgruver@wakehealth.edu | |
| United States, Oregon | |
| Legacy Oregon Burn Center | Withdrawn |
| Portland, Oregon, United States, 97227 | |
| United States, South Carolina | |
| Medical University of South Carolina | Recruiting |
| Charleston, South Carolina, United States, 29425 | |
| Contact: Site Coordinator 843-792-0325 tresslar@musc.edu | |
| Study Director: | Clinical Team Leader | Stratatech, a Mallinckrodt Company |
| Responsible Party: | Stratatech, a Mallinckrodt Company |
| ClinicalTrials.gov Identifier: | NCT04765202 |
| Other Study ID Numbers: |
MNK01062117 |
| First Posted: | February 21, 2021 Key Record Dates |
| Last Update Posted: | May 24, 2023 |
| Last Verified: | May 2023 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
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