StrataGraft Overlay of Meshed Autograft in Full-thickness Thermal Burns

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

13 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-10-10

Study Completion Date

2024-06-07

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

StrataGraft® Skin Tissue in the Promotion of Autologous Skin Regeneration of Complex Skin Defects Due to Thermal Burns That Contain Intact Dermal Elements

NCT03005106

Burn, Thermal

COMPLETED PHASE3

StrataGraft Safety, Tolerability and Efficacy in Pediatric Subjects

NCT05517902

Skin Wound Burns Trauma-related Wound

COMPLETED PHASE3

StrataGraft® Skin Tissue as an Alternative to Autografting Deep Partial-Thickness Burns

NCT01437852

Skin Wound Burns Trauma-related Wound

COMPLETED PHASE1

StrataGraft® Skin Tissue as an Alternative to Autografting Full-thickness Complex Skin Defects

NCT03005054

Trauma-related Wound Burns Skin Wound

TERMINATED PHASE2

Safety and Efficacy Study of Autologous Engineered Skin Substitute to Treat Partial- and Full-Thickness Burn Wounds

NCT01655407

Thermal Injury Deep Partial-Thickness Burn Full-Thickness Burn

UNKNOWN PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Full Thickness Thermal Burn

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Cohort1 Group1: AG Tx Sites

Participants received autograft treatment (AG Tx) consisting of autograft alone (mesh ratio "m", per clinical judgment) at the treatment site on Day 1.

Group Type EXPERIMENTAL

AG Tx

Intervention Type PROCEDURE

Control treatment that is meshed autograft alone applied to a burn area.

Cohort1 Group1: SOMA Tx Sites

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.

Group Type EXPERIMENTAL

SOMA Tx

Intervention Type BIOLOGICAL

Meshed autograft applied to the burn area and covered with StrataGraft.

Cohort1 Group 2: AG Tx Sites

Participants received AG Tx consisting of autograft alone (mesh ratio "m", per clinical judgment) at the treatment site on Day 1.

Group Type EXPERIMENTAL

AG Tx

Intervention Type PROCEDURE

Control treatment that is meshed autograft alone applied to a burn area.

Cohort1 Group2: SOMA Tx Sites

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.

Group Type EXPERIMENTAL

SOMA Tx

Intervention Type BIOLOGICAL

Meshed autograft applied to the burn area and covered with StrataGraft.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

AG Tx

Control treatment that is meshed autograft alone applied to a burn area.

Intervention Type PROCEDURE

SOMA Tx

Meshed autograft applied to the burn area and covered with StrataGraft.

Intervention Type BIOLOGICAL

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Meshed Autograft StrataGraft skin tissue Overlay of Meshed Autograft (SOMA)

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No