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

NCT06223269 | Recruiting Phase 3 DMC FDA Drug

• 1 other identifier: realSKIN-003
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 4

Brief Summary

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.

Conditions

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

Keywords

Full-thickness Burn; Complete Wound Closure; Durable Wound Closure; Autograft Alternative; 3rd Degree Burn; Mixed-Depth Burn; Partial-thickness Burn; 4th Degree Burn; Xenotransplant; Xenograft; Skin Xenotransplant; realSKIN

Outcome Measures

Primary Outcomes (2)

• 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.)

  Post-Treatment Day 28 (± 7 days)

• Percent Area of Treatment Sites Autografted

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

  Post-Treatment Month 4 (± 1 month)

Secondary Outcomes (2)

• Pain at the Patient Skin Harvest Sites

  Post-Treatment Month 4 (± 1 month)

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

  Post-Treatment Month 4 (± 1 month)

Study Arms (2)

Skin Xenotransplant

EXPERIMENTAL

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.

Drug: Skin Xenotransplant

Autograft

ACTIVE COMPARATOR

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.

Procedure: Autograft(ing)

Interventions

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.

Also known as: realSKIN®

Skin Xenotransplant

Autograft(ing) PROCEDURE

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.

Autograft

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Biological females must have a negative serum pregnancy test at Screening and must not be nursing
• All subjects must agree to use a protocol-approved method of contraception for a minimum of 3 months following realSKIN placement, which includes a barrier method plus one or more of the following:
• 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
• 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

You may not qualify if:

• 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
• Use of any experimental or investigational drugs within 30 days prior to placement of realSKIN
• Previously received a porcine or other xenogeneic tissue product, including but not limited to: glutaraldehyde fixed porcine or bovine bioprosthetic heart valve replacements and glutaraldehyde fixed porcine dermal matrix (e.g., EZ Derm)
• Patients with advanced or unstable/uncontrolled comorbid conditions, such as advanced renal disease, diabetes mellitus and liver disease
• Patients with HbA1c ≥ 10.0%; specimen must be obtained for screening purposes if current (within past 3 months) value is not available
• Patients with a history of chronic end stage renal disease defined as MDRD CrCL \< 15mL/min or receiving chronic dialysis
• Patients with a history of chronic liver disease or cirrhosis (Child-Pugh Score C); evidence of acute or chronic hepatitis B infection based on documented HBV serology testing
• Known documented history of Hepatitis B, Hepatitis C, Treponema pallidum, Cytomegalovirus, herpes or varicella zoster; note: Successfully treated hepatitis C patients without evidence of end stage liver disease is allowed; if HCV antibody reactive, then HCV RNA must be undetectable
• 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)
• Presence of venous or arterial vascular disorder directly affecting the area of burn wound
• Pre-existing haemolytic anemia
• Chronic malnourishment as determined by Investigator

Sponsors & Collaborators

• XenoTherapeutics, Inc.: lead
• Joseph M. Still Research Foundation, Inc.: collaborator

Study Sites (4)

Arizona Burn Center Valleywise Health

Phoenix, Arizona, 85008, United States

RECRUITING

JMS Burn Center at Doctors Hospital

Augusta, Georgia, 30909, United States

RECRUITING

MaineHealth Maine Medical Center

Portland, Maine, 04102, United States

NOT YET RECRUITING

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

NOT YET RECRUITING

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MeSH Terms

Conditions

Burns

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Officials

• Bounthavy Homsombath, MD

  JMS BURN CENTER AT DOCTORS HOSPITAL OF AUGUSTA

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jon Adkins, MBA

CONTACT

6179397893; clinicaltrials@xenotx.org

Kaitlyn Rogers, PhD(C)

CONTACT

6179397893; clinicaltrials@xenofoundation.org

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Open-label, interventional, controlled, randomized, multicenter clinical trial. Each patient represents both the experimental and control group, to be evaluated in isolated but comparable settings. The use of an intra-patient comparator allows for a matched control to eliminate significant underlying differences. Treatment assignment will be randomized to receive either realSKIN or a surgically harvested autograft.

Study Record Dates

• First Submitted: June 15, 2023
• First Posted: January 25, 2024
• Study Start: May 9, 2024
• Primary Completion: December 1, 2025
• Study Completion: January 1, 2026
• Last Updated: April 2, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)