protocolSection identificationModule nctId: NCT06313385, orgStudyIdInfo id: 22-10-1180, briefTitle: Investigating the Impact of Indocyanine Green Titration on Fluorescent Intensity in Free Flap : An Exploration of Alternative Indicators, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2023-01-01, primaryCompletionDateStruct date: 2024-03-29, completionDateStruct date: 2024-03-29, studyFirstPostDateStruct date: 2024-03-15, lastUpdatePostDateStruct date: 2024-03-15, sponsorCollaboratorsModule leadSponsor name: Indonesia University, class: OTHER, descriptionModule briefSummary: This study is a randomized clinical trials that aim to determine the effect of Indocyanine Green (ICG) titration dose on the intensity degree of ICG fluorescence imaging results. In addition, this study will also determine the relationship of other indicators such as flap surface temperature, transcutaneous pressure of carbon dioxide (TcPCO2), transcutaneous pressure of oxygen (TcPCO2), HIF - 1 alpha expression, and flap histopathology morphology to the intensity degree of ICG fluorescence imaging results with titrated doses., conditionsModule conditions: Free Flap, conditions: Indocyanine Green, conditions: Microsurgery, conditions: Temperature Change, Body, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: SEQUENTIAL, interventionModelDescription: The population were divided into three equal groups of indocyanine green concentration : 5 milligram per milliliter (mg/mL), 2,5 mg/mL, and 0,5 mg/mL, primaryPurpose: DIAGNOSTIC, maskingInfo masking: QUADRUPLE, maskingDescription: The participants didn't know about indocyanine green (ICG) drug groups as well as the concentration that they received. The ICG was added into the syringe by research assistant without any label near the end of operation time. The ICG injection to the patient was performed by anesthesiologist who didn't know about the concentration at all. Outcome assessor didn't know about the given concentration., whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 63, type: ESTIMATED, armsInterventionsModule interventions name: Indocyanine Green Fluorescence (ICG), interventions name: Temperature, interventions name: Transcutaneous oxygen and carbon dioxide pressure, interventions name: Histopathology, interventions name: Hypoxia inducible factor-1 (HIF-1) alpha, outcomesModule primaryOutcomes measure: The Effect of Indocyanine Green Fluorescence Intensity to evaluate free flap perfusion, secondaryOutcomes measure: The ICG fluorescence intensity in different titration dose with flap surface Temperature, secondaryOutcomes measure: Correlation between ICG fluorescence intensity in different titration dose with transcutaneous carbon dioxide and oxygen pressure, secondaryOutcomes measure: Correlation between ICG fluorescence intensity concentration in different titration dose with flap neutrophile count, secondaryOutcomes measure: Correlation between ICG fluorescence intensity concentration in different titration dose with flap necrosis volume, secondaryOutcomes measure: Correlation between ICG fluorescence intensity concentration in different titration dose with vascular flap proliferation of the tissue, secondaryOutcomes measure: Correlation between ICG fluorescence intensity in different titration dose with HIF-1 Alpha, eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Cipto Mangunkusumo Hospital, Faculty of Medicine, Universitas Indonesia, city: Jakarta Pusat, state: Jakarta, zip: 10430, country: Indonesia, geoPoint lat: -6.1818, lon: 106.8223, hasResults: False