NCT07489560

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

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

• Status: Not Yet Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 70 (estimated)
• Sponsor: Cellution Biologics · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Partial Thickness Burn

Interventions

Type	Name	Description
OTHER	Amnion-Intermediate-Chorion	Dehydrated human placental multilayer allograft derived from donated human tissue. AIC contains amnion and chorion layers as well as basement membrane and trophoblast.
PROCEDURE	Standard of Care (SOC)	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.

Timeline

• Start date: 2026-06-01
• Primary completion: 2027-06-01
• Completion: 2027-06-01
• First posted: 2026-03-24
• Last updated: 2026-03-24