Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 10:49 PM
Ignite Modification Date:
2025-12-24 @ 10:49 PM
NCT ID:
NCT06223269
Eligibility 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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06223269
Study Brief:
Protocol Section:
NCT06223269