RECRUITING

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

Conditions

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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

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

Quick Facts

Study Start:2024-05-09

Study Completion:2025-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06223269

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.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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	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

Inclusion Criteria

Exclusion 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

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

Contacts and Locations

Study Contact

Jon Adkins, MBA

CONTACT

6179397893

clinicaltrials@xenotx.org

Kaitlyn Rogers, PhD(C)

CONTACT

6179397893

clinicaltrials@xenofoundation.org

Principal Investigator

Bounthavy Homsombath, MD

PRINCIPAL_INVESTIGATOR

JMS BURN CENTER AT DOCTORS HOSPITAL OF AUGUSTA

Study Locations (Sites)

Arizona Burn Center Valleywise Health

Phoenix, Arizona, 85008

United States

JMS Burn Center at Doctors Hospital

Augusta, Georgia, 30909

United States

MaineHealth Maine Medical Center

Portland, Maine, 04102

United States

Massachusetts General Hospital

Boston, Massachusetts, 02114

United States

Collaborators and Investigators

Sponsor: XenoTherapeutics, Inc.

Bounthavy Homsombath, MD, PRINCIPAL_INVESTIGATOR, JMS BURN CENTER AT DOCTORS HOSPITAL OF AUGUSTA

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 Registration Dates

Study Start Date2024-05-09

Study Completion Date2025-01

Study Record Updates

Study Start Date2024-05-09

Study Completion Date2025-01

Terms related to this study

Keywords Provided by Researchers

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

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