[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100581987":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":30,"centralContacts":34,"locations":43,"responsibleParty":70,"collaborators":72,"id":76,"slug":77,"hasResults":78,"nctId":79,"briefTitle":80,"officialTitle":81,"acronym":26,"eligibilityCriteria":82,"healthyVolunteers":78,"sex":83,"minAge":84,"maxAge":26,"enrollmentInfo":85,"targetDuration":26,"studyType":88,"phases":89,"briefSummary":91,"conditions":92,"keywords":96,"overallStatus":99,"whyStopped":26,"lastUpdateSubmitDate":100,"lastUpdatePostDateStruct":101,"startDateStruct":104,"completionDateStruct":106,"leadSponsor":108,"locationsCount":109},{"fullName":5,"class":6},"University of Pittsburgh","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Acute Split Thickness Skin Graft (STSG) Reconstruction","ACTIVE_COMPARATOR","In this Arm, the investigators will evaluate full thickness defects generated after fasciotomy, trauma debridement, and\u002For burn excision of the face, neck, or extremities. These wounds represent common, full-thickness injuries, which require prolonged recovery and dressing changes as bridge to either skin graft or delayed closure and commonly are associated with contour irregularities, adhesions, and contracture. The investigators will assess current standard of care dressing changes followed by immediate STSG.",[13],"Procedure: Split Thickness Skin Graft (STSG)",{"label":15,"type":16,"description":17,"interventionNames":18},"Base of wound fat graft with STSG Reconstruction (Autologous Layered Composite Grafting).","EXPERIMENTAL","In this Arm, the investigators will evaluate full thickness defects generated after fasciotomy, trauma debridement, and\u002For burn excision of the face, neck, or extremities. These wounds represent common, full-thickness injuries, which require prolonged recovery and dressing changes as bridge to either skin graft or delayed closure and commonly are associated with contour irregularities, adhesions, and contracture. The investigators will assess current standard of care dressing changes followed by base of wound fat graft with STSG reconstruction (Autologous Layered Composite Grafting).",[19],"Procedure: Base of wound fat graft with STSG Reconstruction (Autologous Layered Composite Grafting).",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"PROCEDURE","Split Thickness Skin Graft (STSG)","Partial thickness skin in STSGs are performed by harvesting via dermatome the donor site. Donor sites are typically taken from a flat surface on the thigh, lower back, or gluteal region to allow for a graft of even thickness and the selection of donor site is to be based on clinical standard practice. These grafts are placed on the prepared recipient site.",[9],null,{"type":22,"name":15,"description":28,"armGroupLabels":29,"otherNames":26},"Autologous Layered Composite Grafting consists of the layered strategy of simultaneous fat and skin grafting. Fat is harvested by minimally invasive liposuction and applied directly to the wound base without any chemical or biologic processing. Skin is harvested as a split thickness skin graft by dermatome and applied over the layer of adipose tissue.",[15],[31],{"name":32,"affiliation":5,"role":33},"Francesco Egro","PRINCIPAL_INVESTIGATOR",[35,40],{"name":36,"role":37,"phone":38,"phoneExt":26,"email":39},"Eleanor Shirley","CONTACT","412-641-8676","shirleye@upmc.edu",{"name":41,"role":37,"phone":38,"phoneExt":26,"email":42},"Patsy Simon","simopa@UPMC.EDU",[44,60],{"facility":45,"status":26,"city":46,"state":47,"zip":48,"country":49,"countryCode":50,"cosmosGeoPoint":51,"geoPoint":56,"contacts":57},"Mercy Hospital","Pittsburgh","Pennsylvania","15219","United States","US",{"type":52,"coordinates":53},"Point",[54,55],-79.99589,40.44062,{"lat":55,"lon":54},[58,59],{"name":36,"role":37,"phone":38,"phoneExt":26,"email":39},{"name":32,"role":33,"phone":26,"phoneExt":26,"email":26},{"facility":61,"status":26,"city":46,"state":47,"zip":48,"country":49,"countryCode":50,"cosmosGeoPoint":62,"geoPoint":64,"contacts":65},"Presbyterian Hospital",{"type":52,"coordinates":63},[54,55],{"lat":55,"lon":54},[66,67],{"name":36,"role":37,"phone":38,"phoneExt":26,"email":39},{"name":68,"role":69,"phone":26,"phoneExt":26,"email":26},"Teun Teunis","SUB_INVESTIGATOR",{"type":33,"investigatorFullName":32,"investigatorTitle":71,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"Director of Burn Reconstruction",[73],{"name":74,"class":75},"Armed Forces Institute of Regenerative Medicine","FED","100581987","autologous-point-of-care-adipose-therapy-recent-injury-100581987",false,"NCT06857448","Autologous Point-of-Care Adipose Therapy: Recent Injury","Autologous Point-of-Care Adipose Therapy for Reconstruction and Regeneration of Traumatized Skin: Recent Injury","Inclusion Criteria:\n\n* The proposed study will include adult patients 18 years of age or older,\n* male or female,\n* civilian, military, active duty or retired veterans\n* presenting for unilateral or bilateral fasciotomy of the extremity at any level necessary\n* secondary to non-infectious etiology,\n* unilateral or bilateral traumatic full-thickness skin loss of the face, head, neck or extremities necessitating reconstruction, and\u002For\n* full or partial thickness burn injury of the face, neck, or extremity requiring excision and\u002For reconstruction.\n* Additional inclusion criteria includes willingness to be randomized to receive a fat graft.\n\nExclusion Criteria:\n\n* Age \\\u003C 18 years of age,\n* active infection,\n* medical co-morbidities or anatomic configuration deemed by the physician to be a concern for safety,\n* unwilling or unable to comply with study procedures,\n* radiation to the site of interest,\n* prisoners and\u002For vulnerable populations.\n* In addition, candidates that are pregnant or plan to become pregnant in the next year, will be excluded.","ALL","18 Years",{"count":86,"type":87},68,"ESTIMATED","INTERVENTIONAL",[90],"NA","The goal of this study is to explore if an adipose-based therapeutic strategy can treat full-thickness soft-tissue trauma wounds in injured individuals, especially those with severe burns or soft-tissue loss. The main question it aims to answer are:\n\n\\- Can immediate autologous adipose and autologous layered composite grafting be effective for acute functional soft-tissue reconstruction?\n\nResearchers will compare the single-stage autologous layered composite grafting method to traditional methods to see if it improves healing outcomes, minimizes scarring, and reduces infection risk.\n\nParticipants will:\n\n* Receive immediate fat grafting into the wound.\n* Undergo simultaneous split-thickness skin grafting for full soft-tissue reconstruction.",[93,94,95],"Burns","Contracture Scar","Surgical Injury",[97,98],"fasciotomy","trauma","NOT_YET_RECRUITING","2025-11-03",{"date":102,"type":103},"2025-11-05","ACTUAL",{"date":105,"type":87},"2025-12",{"date":107,"type":87},"2028-10-30",{"name":5,"class":6},2]