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RECRUITING
NCT06223269
PHASE3

Safety and Efficacy of realSKIN® to Provide Complete Wound Closure of Burn Wounds as an Alternative to Autografting

Sponsor: XenoTherapeutics, Inc.

View on ClinicalTrials.gov

Summary

To evaluate the safety and efficacy of realSKIN® to provide complete wound closure of mixed-depth, full-thickness burn wounds as an alternative treatment to autografting.

Official title: A Phase III Open-Label, Multicenter, Randomized, Controlled Clinical Trial to Evaluate the Safety and Efficacy of realSKIN® to Provide Complete Wound Closure of Mixed-Depth, Full-Thickness Burn Wounds as an Alternative to Autografting

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

50

Start Date

2024-05-09

Completion Date

2026-01

Last Updated

2025-04-02

Healthy Volunteers

No

Interventions

DRUG

Skin Xenotransplant

realSKIN® is a live biotherapeutic, bi-layered, split-thickness, membranous, skin xenotransplant wound dressing manufactured from living porcine skin sourced from genetically engineered, alpha-1,3-galactosyltransferase knock-out (GalT-KO) porcine (Sus scrofa) donors under aseptic conditions. realSKIN® is topically applied to a surgically prepared wound bed via sutures or staples and may be trimmed to fit the shape and size of the wound area.

PROCEDURE

Autograft(ing)

Autograft(ing) is the current standard of care procedure for the treatment of severe burns. The procedure involves the removal of a sheet of healthy skin, i.e. autologous (self) skin harvesting, from an uninjured site on the patient and using it to cover the original burn wound.

Locations (4)

Arizona Burn Center Valleywise Health

Phoenix, Arizona, United States

JMS Burn Center at Doctors Hospital

Augusta, Georgia, United States

MaineHealth Maine Medical Center

Portland, Maine, United States

Massachusetts General Hospital

Boston, Massachusetts, United States