Ignite Creation Date:
2026-03-26 @ 3:19 PM
Ignite Modification Date:
2026-03-31 @ 3:29 AM
Study NCT ID:
NCT07489560
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-03-24
First Post:
2026-03-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
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
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002056', 'term': 'Burns'}], 'ancestors': [{'id': 'D014947', 'term': 'Wounds and Injuries'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D059039', 'term': 'Standard of Care'}], 'ancestors': [{'id': 'D019984', 'term': 'Quality Indicators, Health Care'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D006298', 'term': 'Health Services Administration'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 70}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-06', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2027-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-18', 'studyFirstSubmitDate': '2026-03-18', 'studyFirstSubmitQcDate': '2026-03-18', 'lastUpdatePostDateStruct': {'date': '2026-03-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time to Complete Epithelialization', 'timeFrame': '1-10 weeks', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Percentage of Burn Area Change', 'timeFrame': '1-10 weeks', 'description': 'To evaluate the difference in percentage reduction in burn wound area at each follow-up visit in participants receiving dHAICM versus SOC alone.'}, {'measure': 'Frequency of Full Epithelialization', 'timeFrame': '1-10 weeks', 'description': 'To compare the frequency of full epithelialization at 3 weeks in participants receiving dHAICM versus SOC alone.'}, {'measure': 'Changes in Pain Scores Associated with Target Burns', 'timeFrame': '1-10 weeks', 'description': 'To determine the reduction in pain scores (VAS) for participants during dressing changes.'}, {'measure': 'Changes in Scarring Quality of Target Burn', 'timeFrame': '1-10 weeks', 'description': 'To determine the difference in assessment of scarring quality using the Vancouver Scar Scale (VSS).'}, {'measure': 'Incidents of Adverse Events', 'timeFrame': '1-10 weeks', 'description': 'To determine the difference in the frequency and nature of adverse events in participants receiving dHAICM versus SOC alone.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['thermal burn', 'burn'], 'conditions': ['Partial Thickness Burn']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 years of age or older\n* One or more thermal burns classified as either superficial partial thickness or deep partial thickness.\n* Total Body Surface Area (TBSA) involvement between 5% and 15%.\n* Total burn index wound area is greater than 25 cm 2 and less than 0.25 m 2 (2500 cm 2 )\n* 1 If 2 or more burns are present, each must have an area greater than 15 cm 2\n* The participant must be willing and able to participate in the informed consent process.\n\nExclusion Criteria:\n\n* Full thickness burns.\n* Burns present for \\>72 hours prior to study evaluation\n* Burns requiring immediate autografting.\n* Superficial burns (1 st -degree) or burns not meeting criteria to be included in TBSA calculations.\n* Chemical or electrical burns.\n* Burns secondary to blast injury.\n* Burns causing vascular or respiratory compromise and burns requiring escharotomy\n* Any severe systemic comorbidities which could impair healing (e.g. active sepsis or major organ failure).\n* Known coagulopathy, platelet disorder, INR \\> 1.6, PTT \\> 38s, or platelets \\< 50,000 per mm 3\n* Uncontrolled diabetes.\n* Known life expectancy of \\< 6 months.\n* Evidence of active infection in burn.\n* Target area for treatment includes the head, neck, palms of hands, soles of the feet, or genitals.\n* Viral infection which could impair healing or immune function (e.g. HIV, HBV, HCV)\n* 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.\n* Currently requiring dialysis or planning to start within 6 months.\n* Medical or psychological condition that, in the opinion of the investigator, may interfere with study assessments.\n* Treated with hyperbaric oxygen therapy or a skin substitute within the 30 days prior to screening visit.\n* Sensitivity to ofloxacin, vancomycin, or amphotericin antibiotics.\n* Participation in a clinical trial involving treatment with an investigational product within the previous 30 days.'}, 'identificationModule': {'nctId': 'NCT07489560', 'acronym': 'PHOENIX', 'briefTitle': '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', 'organization': {'class': 'INDUSTRY', 'fullName': 'Cellution Biologics'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'CELLBIO-2026-002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Standard of Care', 'description': '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.', 'interventionNames': ['Procedure: Standard of Care (SOC)']}, {'type': 'EXPERIMENTAL', 'label': 'AIC and Standard of Care', 'description': '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.', 'interventionNames': ['Other: Amnion-Intermediate-Chorion', 'Procedure: Standard of Care (SOC)']}], 'interventions': [{'name': 'Amnion-Intermediate-Chorion', 'type': 'OTHER', 'description': 'Dehydrated human placental multilayer allograft derived from donated human tissue. AIC contains amnion and chorion layers as well as basement membrane and trophoblast.', 'armGroupLabels': ['AIC and Standard of Care']}, {'name': 'Standard of Care (SOC)', 'type': 'PROCEDURE', 'description': '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.', 'armGroupLabels': ['AIC and Standard of Care', 'Standard of Care']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Bryanna Finstein', 'role': 'CONTACT', 'email': 'bryanna.f@cellutionbiologics.com', 'phone': '6035574660'}, {'name': 'Cellution Research', 'role': 'CONTACT', 'email': 'clinical@cellutionbiologics.com', 'phone': '6035574660'}], 'overallOfficials': [{'name': 'Study Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Cellution Biologics'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cellution Biologics', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}