[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"surgical-flap-ischemia\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:surgical-flap-ischemia":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":17,"targetDuration":4,"studyType":20,"phases":21,"briefSummary":23,"conditions":24,"keywords":28,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":5},"100655295","randomized-evaluation-of-indocyanine-green-fluorescence-angiography-guided-versus-standard-clinical-perfusion-assessment-during-gluteal-permanent-synthetic-filler-removal-100655295",false,"NCT07808957","Randomized Evaluation of Indocyanine Green Fluorescence Angiography-Guided Versus Standard Clinical Perfusion Assessment During Gluteal Permanent Synthetic Filler Removal","Inclusion Criteria:\n\n* Age 18 to 65 years.\n* Scheduled for elective gluteal permanent synthetic filler removal with flap elevation and primary closure.\n* Expected availability of the study fluorescence imaging system.\n* Ability to provide written informed consent and complete 90-day wound follow-up.\n\nExclusion Criteria:\n\n* Known hypersensitivity to indocyanine green.\n* Pregnancy or breastfeeding.\n* Emergency surgery, uncontrolled sepsis, or hemodynamic instability at the time of randomization.\n* Severe hepatic dysfunction or another condition judged by anesthesia to make indocyanine green inappropriate.\n* Prior enrollment in this trial for a contralateral or repeat operation.\n* Inability to undergo standardized postoperative wound assessment.","ALL","18 Years",{"count":18,"type":19},300,"ESTIMATED","INTERVENTIONAL",[22],"NA","This randomized clinical trial will compare indocyanine green fluorescence angiography-guided assessment with standard clinical assessment of gluteal flap perfusion during removal of permanent synthetic fillers. Participants will be assigned 1:1 to fluorescence-guided or standard management. The primary outcome is the occurrence of flap ischemia, ischemia-related wound dehiscence, or tissue necrosis through postoperative day 30. Dye-related adverse reactions, management changes, wound healing, infection, and reoperation will also be evaluated.",[25,26,27],"Soft Tissue Filler Complication","Surgical Flap Ischemia","Tissue Necrosis",[29,30,31,32,33,27,34],"Indocyanine Green","Fluorescence Angiography","Perfusion Imaging","Gluteal Flap","Wound Dehiscence","Biopolymers","NOT_YET_RECRUITING","2026-09-07",{"date":38,"type":39},"2026-09-09","ACTUAL",{"date":41,"type":19},"2026-10-01",{"date":43,"type":19},"2027-10-01",{"name":45,"class":46},"Research Inc","INDUSTRY"]