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realSKIN® for Severe Burn Wounds

This study is testing a new treatment called realSKIN® for severe burn wounds, including full-thickness and deep partial burns. realSKIN® is a special dressing made from pig skin that has been genetically modified. Researchers want to see if realSKIN® can help burn wounds close completely, similar to or better than the standard treatment, which is an autograft. An autograft involves taking healthy skin from another part of your body to cover the burn. This study is for adults aged 18 and older with severe burns covering less than 50% of their body. The main goals are to see how many wounds close completely by 28 days and how much autografting is still needed after 4 months. The current status of this study is unclear.

Study design
This is a Phase 3, open-label, randomized study involving about 50 men and women. Each patient will receive both realSKIN® and an autograft on different burn areas.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The study will measure wound closure at 28 days and the amount of autografting needed at 4 months after treatment.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06223269

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

Recruiting
PHASE3Ages 18+InterventionalTreatment
XenoTherapeutics, Inc.
~50 participants
Updated 2025-04-02 on ClinicalTrials.gov
What's tested:Skin XenotransplantAutograft(ing)

At a glance

Recruiting sites
2 of 4 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Incidence of Complete Wound Closure at Post-Treatment Day 28 (± 7 days)
Measured over Post-Treatment Day 28 (± 7 days)
+1 more outcome measured

Conditions

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

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Burn

Where it's being run

4 sites across 4 states
Arizona1
Georgia1
Maine1
Massachusetts1

Study leadership

  • Bounthavy Homsombath, MD · PRINCIPAL_INVESTIGATOR · JMS BURN CENTER AT DOCTORS HOSPITAL OF AUGUSTA

Who to contact

Jon Adkins, MBA
[email protected]
6179397893
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Hormonal contraceptives (e.g., birth control pills, skin patches, vaginal rings, and the Depo-Provera shot)
Intrauterine device (IUD)
Male or female condoms with spermicide
Diaphragm with spermicide
Permanent tubal occlusive birth control system 7. Sufficient area of burn wound for realSKIN and comparator autograft placement to not be located on face or hands or having a target graft site centered on high-impact areas such as joints, weight-bearing areas (e.g. soles of feet), or the inguinal region, per Investigator's judgment

What this trial measures

  • Incidence of Complete Wound Closure at Post-Treatment Day 28 (± 7 days)Post-Treatment Day 28 (± 7 days)

    Complete wound closure is defined as \>95% skin re-epithelization in an area of the treatment site without drainage or dressing requirements by Post-Treatment Day 28 (± 7 days). Durable wound closure is defined as confirmation of complete wound closure in an area of the treatment site at two consecutive evaluations, spaced by no less than 14 days and no more than 5 months. Post-Treatment is defined as time elapsed following autografting and treatment with realSKIN, and is not necessarily time elapsed from time of initial time of injury (i.e. in cases where an interim wound dressings were employed prior to autografting.)

  • Percent Area of Treatment Sites AutograftedPost-Treatment Month 4 (± 1 month)

    Percent area of treatment sites autografted is the sum of the percent areas at each assessment/visit.