About this trial
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.
Eligibility criteria
Qualifiers
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 )
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Amnion-Intermediate-Chorion
- Standard of Care (SOC)