Safety and Efficacy of realSKIN® to Provide Complete Wound Closure of Burn Wounds as an Alternati… (NCT06223269) | Clinical Trial Compass
RecruitingPhase 3
Safety and Efficacy of realSKIN® to Provide Complete Wound Closure of Burn Wounds as an Alternative to Autografting
United States50 participantsStarted 2024-05-09
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
âś“. The subject, or the subject's legally authorized representative (LAR), provides written informed consent to participate in this study
âś“. Males or females age greater than or equal to 18 years old
âś“. 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
âś“. Having a mixed depth thermal burn wound including full thickness requiring skin grafting
âś“. Biological females must have a negative serum pregnancy test at Screening and must not be nursing
âś“. 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:
âś“. 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
âś•. Pregnant or lactating women
âś•. 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
What they're measuring
1
Incidence of Complete Wound Closure at Post-Treatment Day 28 (± 7 days)
. 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
âś•. 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
âś•. Use of any experimental or investigational drugs within 30 days prior to placement of realSKIN
âś•. 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)
âś•. 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