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

ConditionsBurns Degree ThirdBurn (Disorder)Burn Degree SecondThermal BurnWound Heal
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

This trial does not accept healthy volunteers

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

Design model

Single group

Treatments tested in this trial

  • Skin Xenotransplant

    Drug

    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.

  • Autograft(ing)

    Procedure/Surgery

    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.

Treatment groups

50 Participants
are divided into 2 treatment groups
Group A: Skin XenotransplantExperimental treatment 1 intervention
Group B: AutograftActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Incidence of Complete Wound Closure at 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.)

Time frame
Post-Treatment Day 28 (± 7 days)
2

Percent Area of Treatment Sites Autografted

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

Time frame
Post-Treatment Month 4 (± 1 month)

Secondary outcomes

1

Pain at the Patient Skin Harvest Sites

Visual Analogue Scale (VAS) scale range from 0 (no pain) to 10 (worst pain). Pain scores assessed up to Post-Treatment Month 4 (± 1 month) are averaged for the summary statistics.

Time frame
Post-Treatment Month 4 (± 1 month)
2

Exploratory Endpoint: Evaluate realSKIN treatment sites for the existence of residual porcine cell populations at Post-Treatment Month 4 (± 1 month).

3 mm skin biopsies will be obtained from enrolled and treated patients of this study who volunteer to provide samples for analysis at post-treatment Month 4 (± 1 month).

Time frame
Post-Treatment Month 4 (± 1 month)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

XenoTherapeutics, Inc.

Lead sponsor

Joseph M. Still Research Foundation, Inc.

Collaborator

Source ClinicalTrials.gov
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