[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"facial-defect\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:facial-defect":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,40],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":28,"lastUpdatePostDateStruct":29,"startDateStruct":32,"completionDateStruct":34,"leadSponsor":36,"locationsCount":39},"100573548","autologous-fresh-fat-grafting-followed-by-autologous-cryopreserved-fat-grafting-100573548",false,"NCT06747715","Autologous Fresh Fat Grafting Followed by Autologous Cryopreserved Fat Grafting","Minimally Invasive Post-Traumatic Craniofacial Soft Tissue Regeneration: Validation of Safety and Efficacy of Staged Approach Using Autologous Fresh Fat Grafting Followed by Autologous Cryopreserved Fat Grafting","Inclusion Criteria:\n\n* Aged 18 years or older and able to provide informed consent,\n* Have suffered injury resulting in craniofacial volume defects which could be treated with a graft volume of between 3 and 150 cc of lipoaspirate (the patient's own fat, collected through liposuction). This may include patients who have not had craniofacial surgical procedures, as well as those who have undergone surgical procedures and have remaining deformities (post-surgical deformities).\n* Be at least 3 months post-injury or most recent surgery, so that acute edema (swelling) is resolved.\n* Volume defects (facial injury) are covered by intact skin and do not communicate with oral cavity or sinuses.\n* The three-dimensional geometry of the volume defects (facial injury) would allow for treatment with fat grafting.\n* Has sufficient donor tissue, as assessed on physical exam, to graft deformity and cryostore an equal amount of adipose (fat) tissue.\n* Willing and able to comply with follow up examinations, including radiographic studies (i.e. CT scans)\n\nExclusion Criteria:\n\n* Age less than 18 years.\n* Inability to provide informed consent.\n* Craniofacial defects intended for treatment have open wounds or communicate with oral cavity or sinus (note: A second facial injury, that will not be treated by the study, that includes this type of defect, will not necessarily exclude the patient from participating).\n* Active infection anywhere in the body.\n* Systemic disease or medical condition that would render the fat harvest and injection procedure, along with associated anesthesia, unsafe to the patient.\n* History of radiation to the areas intended for treatment or the graft harvest site\n* Medications that would significantly impact wound healing, such as immunosuppressive agents, chronic steroid treatment, or chemotherapy, or medications\u002Fallergies that would pose a risk to anesthesia or the planned procedures.\n* Active narcotic abuse (presents a variable for pain logs).\n* Known coagulopathy (increased risk of bleeding\u002Fdelay in forming blood clots).","ALL","18 Years",{"count":19,"type":20},22,"ESTIMATED","INTERVENTIONAL",[23],"NA","The goal of this clinical trial is to validate the safety and effectiveness of a two-stage approach for minimally invasive craniofacial soft tissue reconstruction using autologous fat grafting in wounded service members and veterans. The main questions it aims to answer are:\n\n1. Will treating subjects with post-traumatic craniofacial deformities using fresh fat grafts, followed by a second treatment 3 months later with cryopreserved fat stored at -80°C, improve facial tissue regeneration and appearance?\n2. How do volume retention and tissue health change between fresh and cryopreserved grafts in humans?\n3. How do factors such as cellular composition of the graft, patient demographics, and medical conditions (including diabetes, tobacco use, medications, age, and BMI) affect fat graft volume retention and overall outcomes?\n\nResearchers will compare results from the second-stage cryopreserved fat grafting to fresh fat grafting to assess outcomes like volume retention, patient recovery, and cost reduction.\n\nParticipants will:\n\nUndergo an initial fat grafting procedure. Have additional fat harvested and cryo-stored for use in a second-stage procedure.\n\nReceive the cryopreserved fat in a later stage without the need for a second fat harvest.\n\nReceive small test injections behind each ear for later analysis. Provide data on demographics and medical conditions for correlation with outcomes.",[26],"Facial Defect","RECRUITING","2026-10-05",{"date":30,"type":31},"2026-10-07","ACTUAL",{"date":33,"type":31},"2025-10-01",{"date":35,"type":20},"2028-12-31",{"name":37,"class":38},"University of Pittsburgh","OTHER",1,{"id":41,"slug":42,"hasResults":11,"nctId":43,"briefTitle":44,"officialTitle":44,"acronym":4,"eligibilityCriteria":45,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":46,"targetDuration":4,"studyType":21,"phases":48,"briefSummary":50,"conditions":51,"keywords":52,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":58,"lastUpdatePostDateStruct":59,"startDateStruct":61,"completionDateStruct":63,"leadSponsor":65,"locationsCount":39},"100202507","phase-4-the-role-of-antibiotics-in-full-thickness-skin-graft-survival-for-facial-reconstructive-surgery-100202507","NCT01912651","The Role of Antibiotics in Full Thickness Skin Graft Survival for Facial Reconstructive Surgery","Inclusion Criteria:\n\n* all adult patients with a nasal or facial skin\u002Fsoft tissue defect requiring reconstruction limited to or including a full-thickness skin graft\n\nExclusion Criteria:\n\n* current or recent (within one week of surgery) systemic antibiotic use, intolerance to both clindamycin and cephalexin, discovery of a persistent cutaneous malignancy at the site of the defect following the reconstructive procedure and previous reconstruction at the site of the skin\u002Fsoft-tissue defect.",{"count":47,"type":20},300,[49],"PHASE4","Antibiotics are sometimes prescribed to patients who have had reconstructive surgery of wounds on their face using skin grafts. But, it is not yet known whether antibiotics improve the healing of skin grafts and reduce the risk of infections after surgery in these patients. It is known that antibiotics, like all medications, have side-effects although these are rare. This research study is designed to show us whether antibiotics improve wound healing or not, so that we may determine if we should continue using antibiotics even if they have side-effects in some patients.\n\nOur hypothesis is that patients treated with post-operative, systemic antibiotics will demonstrate a statistically significant improvement in the survival of their facial full thickness skin grafts compared to patients who are not treated with systemic antibiotics.",[26],[53,54,55,56,57],"facial skin wound","facial wound","skin wound","facial defect","reconstructive skin graft","2025-03-15",{"date":60,"type":31},"2025-03-19",{"date":62,"type":31},"2013-07",{"date":64,"type":20},"2028-09",{"name":66,"class":38},"University of Michigan"]