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.
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 )
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.
Single group
Amnion-Intermediate-Chorion
Other interventionDehydrated human placental multilayer allograft derived from donated human tissue. AIC contains amnion and chorion layers as well as basement membrane and trophoblast.
Standard of Care (SOC)
Procedure/SurgeryStandard of care is to establish a clean, healthy wound bed and optimize the wound environment to have the best chance of healing the wound. This is achieved through wound cleansing, debridement, offloading and moisture balance.
Time to Complete Epithelialization
Standard of care is to establish a clean, healthy wound bed and optimize the wound environment to have the best chance of healing the wound. This is achieved through wound cleansing, debridement, offloading and moisture balance.
Percentage of Burn Area Change
To evaluate the difference in percentage reduction in burn wound area at each follow-up visit in participants receiving dHAICM versus SOC alone.
Frequency of Full Epithelialization
To compare the frequency of full epithelialization at 3 weeks in participants receiving dHAICM versus SOC alone.
Changes in Pain Scores Associated with Target Burns
To determine the reduction in pain scores (VAS) for participants during dressing changes.
Changes in Scarring Quality of Target Burn
To determine the difference in assessment of scarring quality using the Vancouver Scar Scale (VSS).
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