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

Part of paid clinical trials in Phoenix, Arizona.

Sponsor
XenoTherapeutics, Inc.
Study ID
NCT06223269
Phase
PHASE3
Status
Recruiting
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Conditions

  • Burn (Disorder)
  • Burn Degree Second
  • Burns Degree Third
  • Thermal Burn
  • Wound Heal

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Skin Xenotransplant — DRUG
    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.
  • Autograft(ing) — PROCEDURE
    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.

Study Details

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.

Key Dates

Start date
May 9, 2024
Status verified
Apr 2025
Primary completion
Dec 31, 2025
Completion
Jan 31, 2026

Study Design

Enrollment
50 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Skin Xenotransplant
    After surgical preparation of the wound beds, subjects will receive approximately 100 square centimeters of realSKIN® at one site, and autograft at the other site, per the standard of care, in accordance with the randomization schedule.
  • Active Comparator: Autograft
    The comparator control for the study is autografting: the current standard of care procedure for the treatment of severe burns involves the removal of a sheet of healthy skin from an uninjured site on the patient and using it to cover the original burn wound to achieve complete and durable wound closure.

Primary Outcome Measure

Incidence of Complete Wound Closure at Post-Treatment Day 28 (± 7 days) [ Time Frame: Post-Treatment Day 28 (± 7 days) ]

Central Contacts

Locations (4)

FacilityCityStateZIPSite coordinators
Arizona Burn Center Valleywise HealthPhoenixArizona85008
Karen Richey, BSN, RN
[email protected]
602-344-5751
JMS Burn Center at Doctors HospitalAugustaGeorgia30909
Joan Wilson, MSN, MHA, RN
[email protected]
706-364-2966
MaineHealth Maine Medical CenterPortlandMaine04102
Damien W Carter, MD
Massachusetts General HospitalBostonMassachusetts02114
Domenic Annand
617-726-3712

Find similar trials in Phoenix, AZ

By research site
Arizona Burn Center Valleywise Health· Phoenix, AZJMS Burn Center at Doctors Hospital· Augusta, GAMaineHealth Maine Medical Center· Portland, MEMassachusetts General Hospital· Boston, MA

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