NCT03695939View on ClinicalTrials.gov

Evaluation of Safety and Efficacy of realSKIN® (Skin Xenotransplant) for Complete Closure of Severe Burn Wounds

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

25

Participants

Timeline

Start Date

March 15, 2019

Primary Completion Date

December 30, 2023

Study Completion Date

December 30, 2023

Conditions
Deep Full-thickness Burn Injury (Disorder)
Interventions
BIOLOGICAL

realSKIN (skin xenotransplant)

3+3 Dose-escalation Study Design; 2 dosage strengths will be utilized during this Phase 1/2 Trial; an expansion cohort (9 patients) receive the highest dose.

BIOLOGICAL

Human Cadaver Allograft

HCA is used as a temporary wound dressing between debridement and definitive closure in many well-resourced contexts.

Trial Locations (2)

30909

JMS Burn Center at Doctors Hospital, Augusta

02114

Massachusetts General Hospital, Boston

All Listed Sponsors
collaborator

Massachusetts General Hospital

OTHER

collaborator

Joseph M. Still Research Foundation, Inc.

OTHER

lead

XenoTherapeutics, Inc.

OTHER

NCT03695939 - Evaluation of Safety and Efficacy of realSKIN® (Skin Xenotransplant) for Complete Closure of Severe Burn Wounds | Biotech Hunter | Biotech Hunter