[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100630583":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":32,"centralContacts":36,"locations":26,"responsibleParty":45,"collaborators":26,"id":47,"slug":48,"hasResults":49,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":53,"eligibilityCriteria":54,"healthyVolunteers":49,"sex":55,"minAge":56,"maxAge":26,"enrollmentInfo":57,"targetDuration":26,"studyType":60,"phases":61,"briefSummary":63,"conditions":64,"keywords":66,"overallStatus":69,"whyStopped":26,"lastUpdateSubmitDate":70,"lastUpdatePostDateStruct":71,"startDateStruct":74,"completionDateStruct":76,"leadSponsor":78,"locationsCount":26},{"fullName":5,"class":6},"Cellution Biologics","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"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.",[13],"Procedure: Standard of Care (SOC)",{"label":15,"type":16,"description":17,"interventionNames":18},"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.",[19,13],"Other: Amnion-Intermediate-Chorion",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"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.",[15],null,{"type":28,"name":29,"description":30,"armGroupLabels":31,"otherNames":26},"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.",[15,9],[33],{"name":34,"affiliation":5,"role":35},"Study Director","STUDY_DIRECTOR",[37,42],{"name":38,"role":39,"phone":40,"phoneExt":26,"email":41},"Bryanna Finstein","CONTACT","6035574660","bryanna.f@cellutionbiologics.com",{"name":43,"role":39,"phone":40,"phoneExt":26,"email":44},"Cellution Research","clinical@cellutionbiologics.com",{"type":46,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR","100630583","phase-4-evaluation-of-safety-and-efficacy-of-dehydrated-human-amnion-intermediate-chorion-membrane-dhaicm-allograft-in-treatment-of-partial-thickness-thermal-burns-100630583",false,"NCT07489560","Evaluation of Safety and Efficacy of Dehydrated Human Amnion-Intermediate-Chorion Membrane (dHAICM) Allograft in 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","PHOENIX","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\u002For 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.","ALL","18 Years",{"count":58,"type":59},70,"ESTIMATED","INTERVENTIONAL",[62],"PHASE4","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\u002FPs), 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.",[65],"Partial Thickness Burn",[67,68],"thermal burn","burn","NOT_YET_RECRUITING","2026-08-04",{"date":72,"type":73},"2026-08-06","ACTUAL",{"date":75,"type":59},"2026-10",{"date":77,"type":59},"2027-12",{"name":5,"class":6}]