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Trial record 1 of 1 for:    NCT06223269
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Safety and Efficacy of realSKIN® to Provide Complete Wound Closure of Burn Wounds as an Alternative to Autografting

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ClinicalTrials.gov Identifier: NCT06223269
Recruitment Status : Recruiting
First Posted : January 25, 2024
Last Update Posted : May 13, 2024
Sponsor:
Collaborator:
Joseph M. Still Research Foundation, Inc.
Information provided by (Responsible Party):
XenoTherapeutics, Inc.

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.

Condition or disease Intervention/treatment Phase
Burns Degree Third Burn (Disorder) Burn Degree Second Thermal Burn Wound Heal Drug: Skin Xenotransplant Procedure: Autograft(ing) Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Intervention Model Description: 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.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : May 9, 2024
Estimated Primary Completion Date : September 2024
Estimated Study Completion Date : November 2024

Resource links provided by the National Library of Medicine


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 Name: 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.




Primary Outcome Measures :
  1. 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.)


  2. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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).



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06223269


Contacts
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Contact: Jon Adkins, MBA 6179397893 clinicaltrials@xenotx.org
Contact: Joan Wilson, MSN, MHA, RN 7063642966 joan.wilson@jmsresearchfoundation.org

Locations
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United States, Arizona
Arizona Burn Center Valleywise Health Not yet recruiting
Phoenix, Arizona, United States, 85008
Contact: Karen Richey, BSN, RN    602-344-5751    Karen.Richey2@valleywisehealth.org   
United States, Georgia
JMS Burn Center at Doctors Hospital Recruiting
Augusta, Georgia, United States, 30909
Contact: Joan Wilson, MSN, MHA, RN    706-364-2966    joan.wilson@jmsresearchfoundation.org   
United States, Massachusetts
Massachusetts General Hospital Not yet recruiting
Boston, Massachusetts, United States, 02114
Contact: Domenic Annand    617-726-3712      
United States, Wisconsin
University Hospital Not yet recruiting
Madison, Wisconsin, United States, 53792
Contact: Angela Gibson, MD         
Sponsors and Collaborators
XenoTherapeutics, Inc.
Joseph M. Still Research Foundation, Inc.
Investigators
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Principal Investigator: Bounthavy Homsombath, MD JMS BURN CENTER AT DOCTORS HOSPITAL OF AUGUSTA
Publications:

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Responsible Party: XenoTherapeutics, Inc.
ClinicalTrials.gov Identifier: NCT06223269    
Other Study ID Numbers: realSKIN-003
First Posted: January 25, 2024    Key Record Dates
Last Update Posted: May 13, 2024
Last Verified: May 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by XenoTherapeutics, Inc.:
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
Additional relevant MeSH terms:
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Wounds and Injuries
Burns