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 (PHOENIX)

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

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 Overview

• Status: Not yet recruiting
• Conditions: Partial Thickness Burn
• Intervention / Treatment: Procedure: Standard of Care (SOC); Other: Amnion-Intermediate-Chorion

• Study Type: Interventional
• Enrollment (Estimated): 70
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Cellution Research; Phone Number: 6035574660; Email: clinical@cellutionbiologics.com
• Study Contact Backup: Name: Bryanna Finstein; Phone Number: 6035574660; Email: bryanna.f@cellutionbiologics.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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 )
• 1 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.

Exclusion Criteria:

• 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.
• Currently requiring dialysis or planning to start within 6 months.
• Medical or psychological condition that, in the opinion of the investigator, may interfere with study assessments.
• Treated with hyperbaric oxygen therapy or a skin substitute within the 30 days prior to screening visit.
• Sensitivity to ofloxacin, vancomycin, or amphotericin antibiotics.
• Participation in a clinical trial involving treatment with an investigational product within the previous 30 days.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Standard of Care; 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); 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.
Experimental: AIC and Standard of Care; 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.	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.; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	1-10 weeks
Frequency of Full Epithelialization	To compare the frequency of full epithelialization at 3 weeks in participants receiving dHAICM versus SOC alone.	1-10 weeks
Changes in Pain Scores Associated with Target Burns	To determine the reduction in pain scores (VAS) for participants during dressing changes.	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).	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.	1-10 weeks

Collaborators and Investigators

• Sponsor: Cellution Biologics
• Investigators: Study Director: Study Director, Cellution Biologics

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2027

Study Registration Dates

• First Submitted: March 18, 2026
• First Submitted That Met QC Criteria: March 18, 2026
• First Posted (Actual): March 24, 2026

Study Record Updates

• Last Update Posted (Actual): March 24, 2026
• Last Update Submitted That Met QC Criteria: March 18, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: burn; thermal burn
• Additional Relevant MeSH Terms: Wounds and Injuries; Burns; Health Services Administration; Health Care Quality, Access, and Evaluation; Quality of Health Care; Quality Indicators, Health Care; Standard of Care
• Other Study ID Numbers: CELLBIO-2026-002

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No