Safety and Efficacy of realSKIN® to Provide Complete Wound Closure of Burn Wounds as an Alternative to Autografting
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorXenoTherapeutics, Inc.
About this trial
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.
Eligibility criteria
Qualifiers
The subject, or the subject's legally authorized representative (LAR), provides written informed consent to participate in this study
Males or females age greater than or equal to 18 years old
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
Having a mixed depth thermal burn wound including full thickness requiring skin grafting
Disqualifiers
Pregnant or lactating women
Documented history of infection with human immunodeficiency virus (HIV) or other condition(s) that in the opinion of the Investigator may compromise patient safety or study objectives
Immunosuppressive medication regimens e.g. antineoplastics, high dose steroids (>10 mg prednisone/day), TNF alpha inhibitors, calcineurin inhibitors (cyclosporine, tacrolimus), anti- proliferative agents, and other immunomodulators
Active malignancy, including those requiring surgery, chemotherapy, and/or radiation in the past 5 years; non-metastatic basal or squamous cell carcinoma of the skin and cervical carcinoma in situ are allowed
Trial design
Treatments tested in this trial
- Skin Xenotransplant
- Autograft(ing)
Treatment groups
50 Participants
are divided into 2 treatment groupsSponsors and collaborators
XenoTherapeutics, Inc.
Lead sponsor
Joseph M. Still Research Foundation, Inc.
Collaborator
Source ClinicalTrials.gov