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

Stratatech

Status and phase: Completed; Phase 2

Conditions: Full Thickness Thermal Burn

Treatments: Procedure: AG Tx; Biological: SOMA Tx

Study type: Interventional

Funder types: Industry

Identifiers

NCT04765202

MNK01062117

Details and patient eligibility

About

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 more widely meshed than AG Tx site 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.

Enrollment: 13 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Has 2% to 49% (inclusive) total body surface area (TBSA) thermal burn area, including areas of 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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13 participants in 1 patient group

All participants

Experimental group

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).

Treatment:

Biological: SOMA Tx

Procedure: AG Tx