[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100651751":3},{"organization":4,"armGroups":7,"interventions":10,"overallOfficials":10,"centralContacts":12,"locations":18,"responsibleParty":37,"collaborators":10,"id":40,"slug":41,"hasResults":42,"nctId":43,"briefTitle":44,"officialTitle":45,"acronym":46,"eligibilityCriteria":47,"healthyVolunteers":42,"sex":48,"minAge":49,"maxAge":50,"enrollmentInfo":51,"targetDuration":54,"studyType":55,"phases":10,"briefSummary":56,"conditions":57,"keywords":63,"overallStatus":70,"whyStopped":10,"lastUpdateSubmitDate":71,"lastUpdatePostDateStruct":72,"startDateStruct":75,"completionDateStruct":77,"leadSponsor":79,"locationsCount":80},{"fullName":5,"class":6},"Research Inc","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":10},"Patients Undergoing Clinically Indicated Gluteal Biopolymer Removal",null,"Participants will be patients scheduled for clinically indicated surgical removal of gluteal biopolymer-infiltrated tissue. The surgical procedure will not be modified by study participation. Experimental thermal and histopathological assessments will be performed only on tissue already removed from the patient.",[13],{"name":14,"role":15,"phone":16,"phoneExt":10,"email":17},"Edison Osorio, MD, Plastic surgeon","CONTACT","+57 314 8644099","info@edisonosorio.com",[19],{"facility":20,"status":10,"city":21,"state":22,"zip":23,"country":24,"countryCode":25,"cosmosGeoPoint":26,"geoPoint":31,"contacts":32},"Clinica Bioderma","Medellín","Antioquia","050022","Colombia","CO",{"type":27,"coordinates":28},"Point",[29,30],-75.57151,6.245,{"lat":30,"lon":29},[33,34],{"name":14,"role":15,"phone":16,"phoneExt":10,"email":17},{"name":35,"role":36,"phone":10,"phoneExt":10,"email":10},"Edison Osorio, MD, plastic surgery","PRINCIPAL_INVESTIGATOR",{"type":36,"investigatorFullName":38,"investigatorTitle":39,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"Brian Ramirez, MD, MSc","MD, Aerospace medicine, MSc, PhD(c); Medical research director - clinical research","100651751","ex-vivo-thermal-damage-assessment-during-electrocautery-cutting-of-explanted-biopolymer-infiltrated-tissue-100651751",false,"NCT07765576","Ex Vivo Thermal Damage Assessment During Electrocautery Cutting of Explanted Biopolymer-Infiltrated Tissue","Prospective Ex Vivo Evaluation of Thermal Damage in Explanted Fat, Fibrotic, and Muscular Tissue From Patients Undergoing Surgical Removal of Gluteal Biopolymers Using Blunt Versus Utah Electrocautery Tips","THERM-BIOPOL","Inclusion Criteria:\n\n* Patients with clinical and\u002For imaging diagnosis of gluteal soft tissue infiltration by biopolymers or alloplastic filler material.\n* Patients scheduled for clinically indicated surgical removal of gluteal biopolymer-infiltrated tissue.\n* Ability to understand the study and provide written informed consent.\n* Availability of explanted tissue suitable for ex vivo thermal and histopathological assessment.\n\nExclusion Criteria:\n\n* Refusal or inability to provide informed consent.\n* Intraoperative finding that explanted tissue is insufficient for ex vivo thermal assessment.\n* Active severe infection requiring urgent deviation from the planned surgical protocol.\n* Extensive tissue necrosis or contamination preventing standardized ex vivo thermal assessment.\n* Specimens that cannot be processed within the predefined time window after explantation.\n* Any situation in which the surgeon determines that research handling of the specimen could interfere with clinical care, pathology required for patient management, or institutional tissue handling policies.\n* Lack of adequate thermographic recording due to technical failure.","ALL","18 Years","55 Years",{"count":52,"type":53},50,"ESTIMATED","1 Day","OBSERVATIONAL","This prospective ex vivo study will evaluate thermal damage produced during electrocautery cutting of explanted tissue from patients undergoing clinically indicated surgical removal of gluteal biopolymers. The study will focus on three tissue types: fat flap tissue, fibrotic tissue, and muscular tissue.\n\nThe clinical surgical procedure will not be modified by study participation. All experimental thermal measurements will be performed on tissue that has already been removed from the patient as part of standard surgical care.\n\nIn fat tissue, standardized blocks measuring 1.25 cm × 1 cm × 1 cm will be prepared from the explanted specimen. Thermal measurements will be performed for each combination of electrocautery tip, power setting, and electrosurgical mode. The evaluated tips will be a blunt electrocautery tip and a Utah electrocautery tip. The evaluated power settings will be 25 watts and 50 watts. The evaluated modes will be cut Blend 2 and coagulation. For each combination, three thermal measurements will be obtained.\n\nIn fibrotic and muscular tissue, due to limited tissue availability, the evaluation will be restricted to 25 watts using the blunt and Utah tips in cut Blend 2 and coagulation modes. Thermal measurements will be obtained from electrocautery cuts performed during removal of the clinically indicated specimen.\n\nThermal measurements will be recorded using a FLIR C3-X thermal camera. The camera settings will include emissivity of 0.95, reflected temperature of 20°C, operating room humidity of 57%, operating room temperature of 22°C, and a fixed measurement distance of 50 cm.\n\nHistopathological evaluation will be performed on one representative sample per experimental combination. The pathology assessor will be blinded to the electrocautery tip, power setting, and mode used for each coded sample. The primary outcome will be maximum histological depth of thermal damage.",[58,59,60,61,62],"Thermal Injury Response","Soft Tissue Disease","Granuloma, Foreign-Body","Foreign-Body Reaction","Foreign Bodies",[64,65,66,67,68,69],"Biopolymer removal","Foreign body reaction","Electrocautery","Thermal injury","Histopathology","Ex vivo study","NOT_YET_RECRUITING","2026-08-13",{"date":73,"type":74},"2026-08-14","ACTUAL",{"date":76,"type":53},"2026-08-16",{"date":78,"type":53},"2026-11-01",{"name":5,"class":6},1]