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

PHASE3RecruitingINTERVENTIONAL
Enrollment

50

Participants

Timeline

Start Date

May 9, 2024

Primary Completion Date

December 31, 2025

Study Completion Date

January 31, 2026

Conditions
Burns Degree ThirdBurn (Disorder)Burn Degree SecondThermal BurnWound Heal
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.

Trial Locations (4)

30909

RECRUITING

JMS Burn Center at Doctors Hospital, Augusta

85008

RECRUITING

Arizona Burn Center Valleywise Health, Phoenix

04102

NOT_YET_RECRUITING

MaineHealth Maine Medical Center, Portland

02114

NOT_YET_RECRUITING

Massachusetts General Hospital, Boston

All Listed Sponsors
collaborator

Joseph M. Still Research Foundation, Inc.

OTHER

lead

XenoTherapeutics, Inc.

OTHER