[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100581986":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":35,"locations":44,"responsibleParty":71,"collaborators":73,"id":77,"slug":78,"hasResults":79,"nctId":80,"briefTitle":81,"officialTitle":82,"acronym":26,"eligibilityCriteria":83,"healthyVolunteers":79,"sex":84,"minAge":85,"maxAge":26,"enrollmentInfo":86,"targetDuration":26,"studyType":89,"phases":90,"briefSummary":92,"conditions":93,"keywords":97,"overallStatus":100,"whyStopped":26,"lastUpdateSubmitDate":101,"lastUpdatePostDateStruct":102,"startDateStruct":105,"completionDateStruct":107,"leadSponsor":109,"locationsCount":110},{"fullName":5,"class":6},"University of Pittsburgh","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Delayed Full Thickness Skin Graft (FTSG) Reconstruction","ACTIVE_COMPARATOR","In this Arm, the investigators will assess FTSGs for reconstruction of defects after burn scar revision of the face, neck, or extremities. Participants will receive any release and\u002For preparation of the scar\u002Fwound bed as would be standard of care and will then receive reconstruction with a FTSG.",[13],"Procedure: Full Thickness Skin Graft (FTSG)",{"label":15,"type":16,"description":17,"interventionNames":18},"Delayed Base of wound fat graft with STSG Reconstruction (Autologous Layered Composite Graft)","EXPERIMENTAL","In this Arm, the investigators will assess Autologous Layered Composite Grafting for reconstruction of defects after burn scar revision of the face, neck, or extremities. Participants will receive any release and\u002For preparation of the scar\u002Fwound bed as would be standard of care and will then receive reconstruction with a Autologous Layered Composite Graft.",[19],"Procedure: Base of wound fat graft with Split Thickness Skin Graft (STSG) Reconstruction (Autologous Layered Composite Grafting).",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"PROCEDURE","Full Thickness Skin Graft (FTSG)","Full thickness skin in FTSGs are harvested by different means by surgeon preference and standard of care. Typically an area of skin with matching color and texture to the site which needs reconstruction is identified from a hidden and\u002For non-cosmetic area and collected via excision. After excision the donor site is closed and the graft is thinned by using a scalpel or scissors to remove excess fat or other soft tissues from the deep surface before being placed in the donor site.",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Base of wound fat graft with Split Thickness Skin Graft (STSG) Reconstruction (Autologous Layered Composite Grafting).","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],[32],{"name":33,"affiliation":5,"role":34},"Francesco Egro","PRINCIPAL_INVESTIGATOR",[36,41],{"name":37,"role":38,"phone":39,"phoneExt":26,"email":40},"Eleanor Shirley","CONTACT","412-641-8676","shirleye@upmc.edu",{"name":42,"role":38,"phone":39,"phoneExt":26,"email":43},"Patsy Simon","simopa@UPMC.EDU",[45,61],{"facility":46,"status":26,"city":47,"state":48,"zip":49,"country":50,"countryCode":51,"cosmosGeoPoint":52,"geoPoint":57,"contacts":58},"Mercy Hospital","Pittsburgh","Pennsylvania","15219","United States","US",{"type":53,"coordinates":54},"Point",[55,56],-79.99589,40.44062,{"lat":56,"lon":55},[59,60],{"name":37,"role":38,"phone":39,"phoneExt":26,"email":40},{"name":33,"role":34,"phone":26,"phoneExt":26,"email":26},{"facility":62,"status":26,"city":47,"state":48,"zip":49,"country":50,"countryCode":51,"cosmosGeoPoint":63,"geoPoint":65,"contacts":66},"Presbyterian Hospital",{"type":53,"coordinates":64},[55,56],{"lat":56,"lon":55},[67,68],{"name":37,"role":38,"phone":39,"phoneExt":26,"email":40},{"name":69,"role":70,"phone":26,"phoneExt":26,"email":26},"Teun Teunis","SUB_INVESTIGATOR",{"type":34,"investigatorFullName":33,"investigatorTitle":72,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"Director of Burn Reconstruction",[74],{"name":75,"class":76},"Armed Forces Institute of Regenerative Medicine","FED","100581986","autologous-point-of-care-adipose-therapy-delayed-injuryscar-100581986",false,"NCT06857435","Autologous Point-of-Care Adipose Therapy: Delayed Injury\u002FScar","Autologous Point-of-Care Adipose Therapy for Reconstruction and Regeneration of Traumatized Skin: Delayed Injury\u002FScar","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 scar contracture release and reconstruction at any level.\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":87,"type":88},40,"ESTIMATED","INTERVENTIONAL",[91],"NA","The goal of this study is to explore if an adipose-based therapeutic strategy can treat contracted scars secondary to soft-tissue burn wounds in injured individuals, especially those with severe burns or soft-tissue loss. The main question it aims to answer are:\n\n\\- Can autologous layered composite grafting demonstrate non-inferiority compared to full-thickness skin grafting for delayed reconstruction of post-burn or trauma scar contracture?\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 fat grafting at time of scar revision.\n* Undergo simultaneous split-thickness skin grafting for full soft-tissue reconstruction.",[94,95,96],"Burns","Contracture Scar","Surgical Injury",[98,99],"burns","scar contracture","NOT_YET_RECRUITING","2025-11-03",{"date":103,"type":104},"2025-11-05","ACTUAL",{"date":106,"type":88},"2025-12",{"date":108,"type":88},"2028-10-30",{"name":5,"class":6},2]