[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100655295":3},{"organization":4,"outcomesModule":7,"designInfo":33,"detailedDescription":43,"studyPopulation":32,"armGroups":44,"interventions":57,"overallOfficials":68,"centralContacts":73,"locations":79,"responsibleParty":93,"collaborators":32,"id":95,"slug":96,"hasResults":97,"nctId":98,"briefTitle":99,"officialTitle":99,"acronym":32,"eligibilityCriteria":100,"healthyVolunteers":97,"sex":101,"minAge":102,"maxAge":32,"enrollmentInfo":103,"targetDuration":32,"studyType":106,"phases":107,"briefSummary":109,"conditions":110,"keywords":114,"overallStatus":120,"whyStopped":32,"lastUpdateSubmitDate":121,"lastUpdatePostDateStruct":122,"startDateStruct":125,"completionDateStruct":127,"leadSponsor":129,"locationsCount":130},{"fullName":5,"class":6},"Research Inc","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":32},[9],{"measure":10,"description":11,"timeFrame":12},"Incidence of Ischemic Gluteal Flap Complications","Proportion of participants with at least one adjudicated event: clinically significant flap ischemia requiring treatment, ischemia-related wound dehiscence, partial-thickness necrosis, or full-thickness necrosis. A masked committee will apply prespecified definitions using clinical records and standardized photographs.","From surgery through postoperative day 30. 30 days",[14,17,21,25,29],{"measure":15,"description":16,"timeFrame":12},"Incidence of Partial- or Full-Thickness Flap Necrosis","Proportion of participants with adjudicated tissue necrosis, reported separately as partial- and full-thickness and by surface area category.",{"measure":18,"description":19,"timeFrame":20},"Intraoperative Change in Surgical Management","Proportion of intervention participants in whom ICG imaging causes additional tissue excision, release of closure tension, change in flap design, delay in closure, or another documented management modification compared with the plan recorded immediately before imaging.","From surgery through postoperative day 30. 30days",{"measure":22,"description":23,"timeFrame":24},"Time to Complete Wound Healing","Number of days from surgery to complete epithelialization without drainage or dressing requirement, censored at 90 days.","From surgery through postoperative day 90. 90 days",{"measure":26,"description":27,"timeFrame":28},"Incidence of Indocyanine Green-Related Adverse Reactions","Proportion of intervention participants with hypersensitivity, urticaria, hemodynamic reaction, bronchospasm, or other adverse event judged related to indocyanine green.","From indocyanine green administration through 24 hours after surgery. 1 day",{"measure":30,"description":31,"timeFrame":24},"Incidence of Reoperation for Wound Complications","Proportion of participants requiring operative debridement, revision closure, grafting, or flap reconstruction for a wound complication.",null,{"allocation":34,"interventionModel":35,"interventionModelDescription":32,"primaryPurpose":36,"observationalModel":32,"timePerspective":32,"maskingInfo":37},"RANDOMIZED","PARALLEL","PREVENTION",{"masking":38,"maskingDescription":32,"whoMasked":39},"TRIPLE",[40,41,42],"PARTICIPANT","INVESTIGATOR","OUTCOMES_ASSESSOR","Adults undergoing gluteal filler-removal surgery with flap elevation will be randomized before definitive flap assessment. In both groups, the surgeon will record the planned closure after routine clinical evaluation. In the intervention group, intravenous indocyanine green and a standardized near-infrared imaging protocol will then be used to identify hypoperfused tissue. Management changes will follow a locked decision algorithm. The control group will proceed using clinical assessment alone. Postoperative wounds will be evaluated by assessors masked to allocation using standardized definitions and photographs through day 90. The trial will compare the 30-day composite ischemic complication rate and will evaluate necrosis, dehiscence, reoperation, time to healing, ICG-related reactions, and quantitative perfusion metrics.",[45,52],{"label":46,"type":47,"description":48,"interventionNames":49},"ICG-Guided Perfusion Assessment (Experimental)","EXPERIMENTAL","Standard clinical assessment plus intraoperative indocyanine green fluorescence angiography. Hypoperfused regions may prompt additional excision, release of tension, or modification of closure according to the locked decision algorithm.",[50,51],"Drug: Indocyanine Green","Procedure: Standard Clinical Perfusion Assessment",{"label":53,"type":54,"description":55,"interventionNames":56},"Standard Clinical Perfusion Assessment (Active Comparator)","ACTIVE_COMPARATOR","Flap perfusion is assessed using routine clinical criteria without fluorescence imaging. All other perioperative care follows the same institutional protocol.",[51],[58,63],{"type":59,"name":60,"description":61,"armGroupLabels":62,"otherNames":32},"DRUG","Indocyanine Green","PROPOSED regimen: 0.05 mg\u002Fkg intravenously followed by a saline flush after flap preparation and before definitive closure; one repeat dose may be used if the image is technically inadequate, within the approved local labeling and maximum dose. Final product, concentration, and dose must be confirmed. Linked arm\u002Fgroup(s): ICG-Guided Perfusion Assessment.",[46],{"type":64,"name":65,"description":66,"armGroupLabels":67,"otherNames":32},"PROCEDURE","Standard Clinical Perfusion Assessment","Surgeon assessment based on tissue color, capillary refill, dermal bleeding, temperature, and clinical judgment. This procedure is used in both groups; the control group does not receive fluorescence imaging. Linked arm\u002Fgroup(s): ICG-Guided Perfusion Assessment, Standard Clinical Perfusion Assessment.",[46,53],[69],{"name":70,"affiliation":71,"role":72},"Edison Osorio, MD, plastic surgery","Bioforma clinic","PRINCIPAL_INVESTIGATOR",[74],{"name":75,"role":76,"phone":77,"phoneExt":32,"email":78},"Edison Osorio, MD, Plastic surgeon","CONTACT","+573226140611","info@edisonosorio.com",[80],{"facility":81,"status":32,"city":82,"state":32,"zip":32,"country":83,"countryCode":84,"cosmosGeoPoint":85,"geoPoint":90,"contacts":91},"Clinica Bioforma","Medellín","Colombia","CO",{"type":86,"coordinates":87},"Point",[88,89],-75.57151,6.245,{"lat":89,"lon":88},[92],{"name":75,"role":76,"phone":77,"phoneExt":32,"email":78},{"type":94,"investigatorFullName":32,"investigatorTitle":32,"investigatorAffiliation":32,"oldNameTitle":32,"oldOrganization":32},"SPONSOR","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":104,"type":105},300,"ESTIMATED","INTERVENTIONAL",[108],"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.",[111,112,113],"Soft Tissue Filler Complication","Surgical Flap Ischemia","Tissue Necrosis",[60,115,116,117,118,113,119],"Fluorescence Angiography","Perfusion Imaging","Gluteal Flap","Wound Dehiscence","Biopolymers","NOT_YET_RECRUITING","2026-09-07",{"date":123,"type":124},"2026-09-09","ACTUAL",{"date":126,"type":105},"2026-10-01",{"date":128,"type":105},"2027-10-01",{"name":5,"class":6},1]