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

January 22, 2024 updated by: XenoTherapeutics, Inc.

A Phase III Open-Label, Multicenter, Randomized, Controlled Clinical Trial to Evaluate the Safety and Efficacy of realSKIN® to Provide Complete Wound Closure of Mixed-Depth, Full-Thickness Burn Wounds as an Alternative to Autografting

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

This study is a Phase 3 open-label, interventional, controlled, randomized, multicenter clinical trial. It is comprised of an estimated 50 men and women aged 18 years and older who experienced severe and extensive, mixed-depth and full-thickness thermal burn wounds up to 50% TBSA requiring surgical excision and skin grafting for which autografting is clinically indicated.

The comparator control for the study is autografting, the current standard of care procedure for the treatment of severe burns, which involves the removal 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.

After surgical preparation of the wound bed, subjects will receive approximately 150 square centimeters of realSKIN at a predesignated wound site and separately, autografting at an alternate site, per the standard of care, in accordance with the randomization schedule.

Thus, 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, including immunologic, physiologic, and scarring variable inherent in this patient population that may impact wound healing at the treatment sites.

After surgical excision to remove nonviable tissue or previously applied temporary wound dressings, two wound treatment sites of comparable area and depth will be identified.

Treatment assignment will be randomized to receive either realSKIN or a surgically harvested autograft. The pre-identified treatment sites must each be a wound area of comparable depth that is not contiguous (e.g., "sharing a common border or touching") to ensure the interpretability of the efficacy results.

Additionally, two unaffected areas of the patient's intact, healthy skin will be prospectively identified to provide sources of autografts for the control site and realSKIN treatment site (e.g., patient skin harvest sites.) These pre-identified regions may be in the same anatomic area or from two separate but comparable areas, depending on the amount of intact native patient skin available.

Study Type

Interventional

Enrollment (Estimated)

50

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85008
        • Arizona Burn Center Valleywise Health
    • Georgia
      • Augusta, Georgia, United States, 30909
        • JMS Burn Center at Doctors Hospital
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital
    • Wisconsin
      • Madison, Wisconsin, United States, 53792
        • University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. The subject, or the subject's legally authorized representative (LAR), provides written informed consent to participate in this study
  2. Males or females age greater than or equal to 18 years old
  3. 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
  4. Having a mixed depth thermal burn wound including full thickness requiring skin grafting
  5. Biological females must have a negative serum pregnancy test at Screening and must not be nursing

  6. 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
  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

Exclusion Criteria:

  1. Pregnant or lactating women
  2. 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
  3. 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
  4. 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
  5. Use of any experimental or investigational drugs within 30 days prior to placement of realSKIN
  6. 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)
  7. Patients with advanced or unstable/uncontrolled comorbid conditions, such as advanced renal disease, diabetes mellitus and liver disease
  8. Patients with HbA1c ≥ 10.0%; specimen must be obtained for screening purposes if current (within past 3 months) value is not available
  9. Patients with a history of chronic end stage renal disease defined as MDRD CrCL < 15mL/min or receiving chronic dialysis
  10. 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
  11. 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
  12. 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)
  13. Presence of venous or arterial vascular disorder directly affecting the area of burn wound
  14. Pre-existing haemolytic anemia
  15. Chronic malnourishment as determined by Investigator
  16. Inhalation injury as determined by bronchoscopic exam if available, or diagnosis at the time of screening
  17. Systemic anticoagulation at the time of treatment or INR > 2
  18. Documented evidence of wound infection at Screening
  19. Evidence of sepsis at Screening

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Skin Xenotransplant
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.
Drug: Skin Xenotransplant

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.

Other Names:
  • realSKIN®
Active Comparator: Autograft
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)
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of Complete Wound Closure at Post-Treatment Day 28 (± 7 days)
Time Frame: 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
Time Frame: Post-Treatment Month 4 (± 1 month)
Percent area of treatment sites autografted is the sum of the percent areas at each assessment/visit.
Post-Treatment Month 4 (± 1 month)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain at the Patient Skin Harvest Sites
Time Frame: Post-Treatment Month 4 (± 1 month)
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.
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).
Time Frame: 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).
Post-Treatment Month 4 (± 1 month)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

XenoTherapeutics, Inc.

Collaborators

Joseph M. Still Research Foundation, Inc.

Investigators

  • Principal Investigator: Bounthavy Homsombath, MD, JMS BURN CENTER AT DOCTORS HOSPITAL OF AUGUSTA

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 10, 2024

Primary Completion (Estimated)

June 1, 2024

Study Completion (Estimated)

September 1, 2024

Study Registration Dates

First Submitted

June 15, 2023

First Submitted That Met QC Criteria

January 22, 2024

First Posted (Actual)

January 25, 2024

Study Record Updates

Last Update Posted (Actual)

January 25, 2024

Last Update Submitted That Met QC Criteria

January 22, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • realSKIN-003

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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