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Trial record 1 of 1 for:    MNK01062117
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StrataGraft Overlay of Meshed Autograft in Full-thickness Thermal Burns (StrataSOMA)

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ClinicalTrials.gov Identifier: NCT04765202
Recruitment Status : Recruiting
First Posted : February 21, 2021
Last Update Posted : June 21, 2022
Sponsor:
Information provided by (Responsible Party):
Mallinckrodt ( Stratatech, a Mallinckrodt Company )

Brief Summary:

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

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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 : June 2023
Estimated Study Completion Date : June 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Burns

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 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)




Primary Outcome Measures :
  1. 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.

  2. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  • 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

Information from the National Library of Medicine

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


Locations
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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 Recruiting
Gainesville, Florida, United States, 32610
Contact: Principal Investigator    352-273-5670    andrea.munden@surgery.ufl.edy   
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. Active, not recruiting
Kansas City, Kansas, United States, 66160
United States, Louisiana
Baton Rouge General Medical Center Recruiting
Baton Rouge, Louisiana, United States, 70809
Contact: Site Coordinator    225-237-1672    patricia.pinsonat@brgeneral.org   
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 Recruiting
Portland, Oregon, United States, 97227
Contact: Site Coordinator    503-413-5447    khickey@lhs.org   
United States, South Carolina
Medical University of South Carolina Recruiting
Charleston, South Carolina, United States, 29425
Contact: Site Coordinator    843-792-8824    hirschj@musc.edu   
Sponsors and Collaborators
Stratatech, a Mallinckrodt Company
Investigators
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Study Director: Clinical Team Leader Stratatech, a Mallinckrodt Company
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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: June 21, 2022
Last Verified: June 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Burns
Wounds and Injuries
Carisoprodol
Muscle Relaxants, Central
Physiological Effects of Drugs
Neuromuscular Agents
Peripheral Nervous System Agents