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StrataGraft Overlay of Meshed Autograft in Full-thickness Thermal Burns (StrataSOMA)

Primary Purpose

Full Thickness Burn

Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
AG Tx
SOMA Tx
Sponsored by
Stratatech, a Mallinckrodt Company
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Full Thickness Burn

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Medstar Washington Hospital CenterRecruiting
  • UF Health Burn Center at the University of Florida
  • Tampa General Hospital / University of South FloridaRecruiting
  • University of Iowa Hospitals and ClinicsRecruiting
  • University of Kansas Medical Center Research Institute, Inc.
  • Baton Rouge General Medical Center
  • Health Partners InstituteRecruiting
  • University of Missouri Health Care
  • Stony Brook UniversityRecruiting
  • Wake Forest Baptist Medical Center Burn CenterRecruiting
  • Legacy Oregon Burn Center
  • Medical University of South CarolinaRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

All participants

Arm Description

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).

Outcomes

Primary Outcome Measures

Number of treatment sites with complete wound closure without additional autografting 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
Durable wound closure is defined as persistence of closure, maintained for at least 3 months after the initial observation of closure.

Secondary Outcome Measures

Full Information

First Posted
February 4, 2021
Last Updated
October 19, 2023
Sponsor
Stratatech, a Mallinckrodt Company
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1. Study Identification

Unique Protocol Identification Number
NCT04765202
Brief Title
StrataGraft Overlay of Meshed Autograft in Full-thickness Thermal Burns
Acronym
StrataSOMA
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 28, 2021 (Actual)
Primary Completion Date
January 2024 (Anticipated)
Study Completion Date
January 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Stratatech, a Mallinckrodt Company

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Full Thickness Burn

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
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.
Allocation
N/A
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
All participants
Arm Type
Experimental
Arm Description
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).
Intervention Type
Procedure
Intervention Name(s)
AG Tx
Other Intervention Name(s)
Meshed Autograft
Intervention Description
The control treatment is meshed autograft applied to a FT burn area
Intervention Type
Biological
Intervention Name(s)
SOMA Tx
Other Intervention Name(s)
StrataGraft skin tissue Overlay of Meshed Autograft (SOMA)
Intervention Description
The experimental treatment is meshed autograft applied to a FT burn area and covered with SOMA
Primary Outcome Measure Information:
Title
Number of treatment sites with complete wound closure without additional autografting at Month 2
Description
Complete wound closure is defined as complete skin re-epithelialization without drainage confirmed at 2 visits at least 2 weeks apart.
Time Frame
at Month 2
Title
Number of subjects with durable wound closure of the study treatment sites without additional autografting at Month 12
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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: the safety or well-being of the participant the study objectives
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Team Leader
Organizational Affiliation
Stratatech, a Mallinckrodt Company
Official's Role
Study Director
Facility Information:
Facility Name
Medstar Washington Hospital Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Phone
202-877-7347
Email
jeffrey.w.shupp@medstar.net
Facility Name
UF Health Burn Center at the University of Florida
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610
Country
United States
Individual Site Status
Withdrawn
Facility Name
Tampa General Hospital / University of South Florida
City
Tampa
State/Province
Florida
ZIP/Postal Code
33606
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Coordinator
Phone
813-844-7873
Email
mjung4@usf.edu
Facility Name
University of Iowa Hospitals and Clinics
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Phone
319-356-3551
Email
lucy-wibbenmeyer@uiowa.edu
Facility Name
University of Kansas Medical Center Research Institute, Inc.
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
Individual Site Status
Withdrawn
Facility Name
Baton Rouge General Medical Center
City
Baton Rouge
State/Province
Louisiana
ZIP/Postal Code
70809
Country
United States
Individual Site Status
Withdrawn
Facility Name
Health Partners Institute
City
Bloomington
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Phone
651-254-1532
Email
sam.a.miotke@healthpartners.com
Facility Name
University of Missouri Health Care
City
Columbia
State/Province
Missouri
ZIP/Postal Code
65212
Country
United States
Individual Site Status
Withdrawn
Facility Name
Stony Brook University
City
Stony Brook
State/Province
New York
ZIP/Postal Code
11794
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Phone
631-624-7101
Email
adam.singer@stonybrookmedicine.edu
Facility Name
Wake Forest Baptist Medical Center Burn Center
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Coordinator
Phone
336-716-4278
Email
cgruver@wakehealth.edu
Facility Name
Legacy Oregon Burn Center
City
Portland
State/Province
Oregon
ZIP/Postal Code
97227
Country
United States
Individual Site Status
Withdrawn
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Coordinator
Phone
843-792-0325
Email
tresslar@musc.edu

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

StrataGraft Overlay of Meshed Autograft in Full-thickness Thermal Burns

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