Evaluation of Safety and Efficacy of Dehydrated Human Amnion-Intermediate-Chorion Membrane (dHAICM) Allograft in Treatment of Partial Thickness Thermal Burns

A Prospective, Multicenter, Randomized, Controlled Clinical Investigation Evaluating the Safety and Efficacy of Dehydrated Human Amnion-Intermediate-Chorion Membrane (dHAICM) Allograft vs Standard of Care in the Treatment of Partial Thickness Thermal Burns

This study will evaluate the efficacy of a dehydrated human placental tissue product, commercially labeled as AmCoreMatrix Burn ™ versus SOC in the closure of partial thickness burns. Human Cellular and Tissue based Products (HCT/Ps), specifically Dehydrated Human Amnion - Intermediate Layer - Chorion Membrane (dHAICM) offer a multimodal biological approach to burn management. Unlike synthetic dressings or silver-based creams, dHAICM serves as a sophisticated bioactive scaffold. It is a minimally manipulated allograft that provides superior tensile strength and barrier function compared to single-layer membranes. This study aims to document its performance in hospital burn units.

Inclusion Criteria:

• 18 years of age or older
• One or more thermal burns classified as either superficial partial thickness or deep partial thickness.
• Total Body Surface Area (TBSA) involvement between 5% and 15%.
• Total burn index wound area is greater than 25 cm 2 and less than 0.25 m 2 (2500 cm 2 )
• 1 If 2 or more burns are present, each must have an area greater than 15 cm 2
• The participant must be willing and able to participate in the informed consent process.

Exclusion Criteria:

• Full thickness burns.
• Burns present for >72 hours prior to study evaluation
• Burns requiring immediate autografting.
• Superficial burns (1 st -degree) or burns not meeting criteria to be included in TBSA calculations.
• Chemical or electrical burns.
• Burns secondary to blast injury.
• Burns causing vascular or respiratory compromise and burns requiring escharotomy
• Any severe systemic comorbidities which could impair healing (e.g. active sepsis or major organ failure).
• Known coagulopathy, platelet disorder, INR > 1.6, PTT > 38s, or platelets < 50,000 per mm 3
• Uncontrolled diabetes.
• Known life expectancy of < 6 months.
• Evidence of active infection in burn.
• Target area for treatment includes the head, neck, palms of hands, soles of the feet, or genitals.
• Viral infection which could impair healing or immune function (e.g. HIV, HBV, HCV)
• Participants of childbearing potential who are pregnant, considering becoming pregnant within the next 6 months, and/or are unwilling to utilize an appropriate form of contraception.
• Currently requiring dialysis or planning to start within 6 months.
• Medical or psychological condition that, in the opinion of the investigator, may interfere with study assessments.
• Treated with hyperbaric oxygen therapy or a skin substitute within the 30 days prior to screening visit.
• Sensitivity to ofloxacin, vancomycin, or amphotericin antibiotics.
• Participation in a clinical trial involving treatment with an investigational product within the previous 30 days.