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Skin Xenotransplant

Skin Xenotransplant for Wound Healing

Phase 3
Recruiting
Led By Bounthavy Homsombath, MD
Research Sponsored by XenoTherapeutics, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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
Biological females must have a negative serum pregnancy test at Screening and must not be nursing
Timeline
Screening 3 weeks
Treatment Varies
Follow Up post-treatment month 4 (± 1 month)
Awards & highlights

Study Summary

This trial will test the safety and effectiveness of realSKIN® in treating deep burns. It aims to see if realSKIN® can fully close the wounds without the need for autografting

Who is the study for?
This trial is for individuals with mixed-depth, full-thickness burn wounds. It's designed to see if realSKIN® can help heal these burns as an alternative to the standard treatment of autografting, where a patient's own skin is used.Check my eligibility
What is being tested?
The study tests the safety and effectiveness of realSKIN®, a new potential treatment for serious burns, against autografting. Participants will be assigned to receive either realSKIN® or undergo traditional autograft surgery.See study design
What are the potential side effects?
Potential side effects may include reactions at the wound site, infection risks associated with skin grafts, and possible complications related to wound healing.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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Less than half of my body has severe burns needing surgery.
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I am not pregnant or breastfeeding.
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I have a severe burn that needs skin grafting.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~post-treatment month 4 (± 1 month)
This trial's timeline: 3 weeks for screening, Varies for treatment, and post-treatment month 4 (± 1 month) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Incidence of Complete Wound Closure at Post-Treatment Day 28 (± 7 days)
Percent Area of Treatment Sites Autografted
Secondary outcome measures
Exploratory Endpoint: Evaluate realSKIN treatment sites for the existence of residual porcine cell populations at Post-Treatment Month 4 (± 1 month).
Pain at the Patient Skin Harvest Sites

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Skin XenotransplantExperimental Treatment1 Intervention
After surgical preparation of the wound beds, subjects will receive approximately 150 square centimeters of realSKIN® at one site, and autograft at the other site, per the standard of care, in accordance with the randomization schedule.
Group II: AutograftActive Control1 Intervention
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.

Find a Location

Who is running the clinical trial?

Joseph M. Still Research Foundation, Inc.OTHER
8 Previous Clinical Trials
308 Total Patients Enrolled
1 Trials studying Wound Healing
93 Patients Enrolled for Wound Healing
XenoTherapeutics, Inc.Lead Sponsor
1 Previous Clinical Trials
25 Total Patients Enrolled
Bounthavy Homsombath, MDPrincipal InvestigatorJMS BURN CENTER AT DOCTORS HOSPITAL OF AUGUSTA
1 Previous Clinical Trials
30 Total Patients Enrolled
~33 spots leftby Sep 2024
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