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
XenoTherapeutics, Inc.
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.
Description
This study is a Phase 3 open-label, interventional, controlled, randomized, multicenter clinical trial. It is comprised of an estimated 50 men and women aged 18 years and older who experienced severe and extensive, mixed-depth and full-thickness thermal burn wounds up to 50% TBSA requiring surgical excision and skin grafting for which autografting is clinically indicated. The comparator control for the study is autografting, the current standard of care procedure for the treatment of severe burns, which involves the removal of healthy skin from an uninjured site on the patient and using it to…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. The subject, or the subject's legally authorized representative (LAR), provides written informed consent to participate in this study 2. Males or females age greater than or equal to 18 years old 3. Total Burn Surface Area (TBSA) \<50% to include mixed depth and full-thickness burn wounds as defined as "primarily full-thickness (FT) and deep-partial (DPT) thermal burns (e.g. \>60% of the total burn area should be FT and DPT) before debridement", and full-thickness burns for which surgical intervention is clinically indicated 4. Having a mixed depth thermal burn wound in…
Interventions
- DrugSkin 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.
- ProcedureAutograft(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 HealthPhoenix, Arizona
- JMS Burn Center at Doctors HospitalAugusta, Georgia
- MaineHealth Maine Medical CenterPortland, Maine
- Massachusetts General HospitalBoston, Massachusetts