Evaluation of 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

Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorCellution Biologics

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)

Treatment groups

70 Participants
are divided into 2 treatment groups

Locations

This trial has no locations

Sponsors and collaborators