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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Dehydrated 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 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.
Time frame: 1-10 weeks
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.
Time frame: 1-10 weeks
Frequency of Full Epithelialization
To compare the frequency of full epithelialization at 3 weeks in participants receiving dHAICM versus SOC alone.
Time frame: 1-10 weeks
Changes in Pain Scores Associated with Target Burns
To determine the reduction in pain scores (VAS) for participants during dressing changes.
Time frame: 1-10 weeks
Changes in Scarring Quality of Target Burn
To determine the difference in assessment of scarring quality using the Vancouver Scar Scale (VSS).
Time frame: 1-10 weeks
Incidents of Adverse Events
To determine the difference in the frequency and nature of adverse events in participants receiving dHAICM versus SOC alone.
Time frame: 1-10 weeks
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