Clinical trial NCT04765202: StrataGraft Overlay of Meshed Autograft in Full-thickness Thermal Burns
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
PHASE2
Conditions: Full Thickness Thermal Burn
Lead sponsor: Mallinckrodt
Sponsor class: INDUSTRY
First posted: 2021-02-21
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.


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 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

Primary outcomes:
measure: Number of Treatment Sites With Complete Wound Closure Without Additional Autografting at Month 2
timeFrame: At Month 2
measure: Number of Participants With Durable Wound Closure of Study Treatment Sites Without Additional Autografting at Month 12
timeFrame: At Month 12
Secondary outcomes:
Other outcomes:
Locations:
city: Washington
country: United States
facility: Medstar Washington Hospital Center
state: District of Columbia
city: Tampa
country: United States
facility: Tampa General Hospital / University of South Florida
state: Florida
city: Iowa City
country: United States
facility: University of Iowa Hospitals and Clinics
state: Iowa
city: Stony Brook
country: United States
facility: Stony Brook University
state: New York
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
Study officials:
affiliation: Stratatech, a Mallinckrodt Company
name: Clinical Team Leader
role: STUDY_DIRECTOR
References: