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

NCT07489560 | Not Yet Recruiting Phase 4

• 1 other identifier: CELLBIO-2026-002
• Study Type: interventional
• Target: 70
• Locations: 0 countries
• Sites: N/A

Brief 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

Keywords

thermal burn; burn

Outcome Measures

Primary Outcomes (1)

• 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.

  1-10 weeks

Secondary Outcomes (5)

• Percentage of Burn Area Change

  1-10 weeks

• Frequency of Full Epithelialization

  1-10 weeks

• Changes in Pain Scores Associated with Target Burns

  1-10 weeks

• Changes in Scarring Quality of Target Burn

  1-10 weeks

• Incidents of Adverse Events

  1-10 weeks

Study Arms (2)

Standard of Care

ACTIVE COMPARATOR

Beginning at the screening visit, participants will receive weekly treatment with standard of care (cleaning, debridement, ulcer moisture balance, and offloading) until ulcer closure, or a maximum of 10 weeks, whichever occurs first.

Procedure: Standard of Care (SOC)

AIC and Standard of Care

EXPERIMENTAL

Participants with a thermal burn classified as either superficial partial thickness or deep partial thickness will receive treatment with an Amnion-Intermediate-Chorion (AIC) sheet product, a dehydrated multilayer human placental tissue derived from donated human tissue, and weekly treatment with standard of care (cleaning, debridement, ulcer moisture balance, and offloading) until ulcer closure, or a maximum of 10 weeks, whichever occurs first.

Other: Amnion-Intermediate-Chorion; Procedure: Standard of Care (SOC)

Interventions

Amnion-Intermediate-Chorion OTHER

Dehydrated human placental multilayer allograft derived from donated human tissue. AIC contains amnion and chorion layers as well as basement membrane and trophoblast.

AIC and Standard of Care

Standard of Care (SOC) PROCEDURE

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.

AIC and Standard of Care; Standard of Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 )
• If 2 or more burns are present, each must have an area greater than 15 cm 2
• The participant must be willing and able to participate in the informed consent process.

You may not qualify if:

• 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.
• Chemical or electrical burns.
• Burns secondary to blast injury.
• Burns causing vascular or respiratory compromise and burns requiring escharotomy
• Any severe systemic comorbidities which could impair healing (e.g. active sepsis or major organ failure).
• Known coagulopathy, platelet disorder, INR \> 1.6, PTT \> 38s, or platelets \< 50,000 per mm 3
• Uncontrolled diabetes.
• Known life expectancy of \< 6 months.
• Evidence of active infection in burn.
• Target area for treatment includes the head, neck, palms of hands, soles of the feet, or genitals.
• Viral infection which could impair healing or immune function (e.g. HIV, HBV, HCV)
• Participants of childbearing potential who are pregnant, considering becoming pregnant within the next 6 months, and/or are unwilling to utilize an appropriate form of contraception.

Sponsors & Collaborators

• Cellution Biologics: lead

MeSH Terms

Conditions

Burns

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Wounds and Injuries

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Study Director

  Cellution Biologics

  STUDY DIRECTOR

Central Study Contacts

Bryanna Finstein

CONTACT

6035574660; bryanna.f@cellutionbiologics.com

Cellution Research

CONTACT

6035574660; clinical@cellutionbiologics.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 18, 2026
• First Posted: March 24, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: March 24, 2026

Record last verified: 2026-03