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Skin Xenotransplant

realSKIN® for Burns

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

Must not have

Recent (within 3 months prior to study enrollment) MI, unstable angina leading to hospitalization, uncontrolled, CABG, PCI, carotid surgery or stenting, cerebrovascular accident, transient ischemic attack, endovascular procedure, or surgical intervention for peripheral vascular disease or plans to undergo a major surgical or interventional procedure (e.g., PCI, CABG, carotid or peripheral revascularization)

Pre-existing haemolytic anemia

Timeline

Screening 3 weeks

Treatment Varies

Follow Up post-treatment month 4 (± 1 month)

Awards & highlights

Pivotal Trial

No Placebo-Only Group

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I haven't had a recent heart attack or any major heart or blood vessel surgery.

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I have a condition where my red blood cells are destroyed faster than they can be made.

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I have lung damage from inhaling harmful substances, confirmed by a lung exam.

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I am on blood thinners or have an INR greater than 2.

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I am not on high-dose steroids or drugs that strongly affect my immune system.

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I do not have severe kidney, liver, or uncontrolled diabetes.

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I have severe chronic kidney disease or am on long-term dialysis.

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I have a blood vessel disorder affecting my burn wound.

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I have severe liver disease or hepatitis B.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ post-treatment month 4 (± 1 month)

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

Percent Area of Treatment Sites Autografted

Secondary study objectives

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

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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 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.

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.

0 / 12Eligibility criteria met