[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100643524":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":35,"centralContacts":40,"locations":45,"responsibleParty":59,"collaborators":34,"id":61,"slug":62,"hasResults":63,"nctId":64,"briefTitle":65,"officialTitle":66,"acronym":67,"eligibilityCriteria":68,"healthyVolunteers":63,"sex":69,"minAge":70,"maxAge":34,"enrollmentInfo":71,"targetDuration":34,"studyType":74,"phases":75,"briefSummary":77,"conditions":78,"keywords":34,"overallStatus":86,"whyStopped":34,"lastUpdateSubmitDate":87,"lastUpdatePostDateStruct":88,"startDateStruct":91,"completionDateStruct":93,"leadSponsor":95,"locationsCount":96},{"fullName":5,"class":6},"Region Skane","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Standard clinical assessment","ACTIVE_COMPARATOR","Participants undergo intraoperative assessment of free flap perfusion using standard clinical assessment methods, including inspection of flap colour, capillary refill, tissue turgor, bleeding upon needle prick, and Doppler examination as clinically indicated. Surgical revision is performed according to standard clinical practice if inadequate perfusion is suspected.",[13],"Procedure: Standard clinical perfusion assessment",{"label":15,"type":16,"description":17,"interventionNames":18},"Indocyanine Green Fluorescence Angiography","EXPERIMENTAL","Participants undergo intraoperative assessment of free flap perfusion using indocyanine green (ICG) fluorescence angiography in addition to standard clinical assessment. ICG is administered intravenously and perfusion is evaluated using near-infrared fluorescence imaging and SPY-Q quantitative perfusion analysis during head and neck free flap reconstruction.",[19,13],"Drug: Indocyanine Green",[21,29],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Indocyanine Green","Indocyanine green (ICG) is administered intravenously during surgery for intraoperative fluorescence angiography assessment of free flap perfusion in head and neck reconstruction. A 25 mg vial of ICG (Verdye®) is reconstituted with sterile water, and approximately 7.5 mg is administered intravenously followed by saline flush. Perfusion is assessed using near-infrared fluorescence imaging systems and SPY-Q quantitative perfusion analysis.",[15],[27,28],"ICG","Verdye",{"type":30,"name":31,"description":32,"armGroupLabels":33,"otherNames":34},"PROCEDURE","Standard clinical perfusion assessment","Standard intraoperative clinical assessment of free flap perfusion including evaluation of flap colour, capillary refill, tissue turgor, bleeding upon needle prick, and Doppler examination as clinically indicated during head and neck free flap reconstruction.",[15,9],null,[36],{"name":37,"affiliation":38,"role":39},"Pooya Rajabaleyan, MD, PhD","Region Skåne, Skånes universitetssjukhus, Sektion Plastikkirurgi, Malmö, Sverige","PRINCIPAL_INVESTIGATOR",[41],{"name":37,"role":42,"phone":43,"phoneExt":34,"email":44},"CONTACT","+4640331000","Pooya.r@hotmail.com",[46],{"facility":47,"status":34,"city":48,"state":34,"zip":34,"country":49,"countryCode":50,"cosmosGeoPoint":51,"geoPoint":56,"contacts":57},"Dept. of Plastic and Reconstructive Surgery and Dept. of Health Sciences, Skåne University Hospital, Malmö, Sweden.","Malmö","Sweden","SE",{"type":52,"coordinates":53},"Point",[54,55],13.00073,55.60587,{"lat":55,"lon":54},[58],{"name":37,"role":42,"phone":43,"phoneExt":34,"email":44},{"type":60,"investigatorFullName":34,"investigatorTitle":34,"investigatorAffiliation":34,"oldNameTitle":34,"oldOrganization":34},"SPONSOR","100643524","phase-4-comparing-intraoperative-indocyanine-green-fluorescence-imaging-with-standard-clinical-assessment-for-flap-perfusion-in-head-and-neck-reconstruction-vision-trial-100643524",false,"NCT07635420","Comparing Intraoperative Indocyanine Green Fluorescence Imaging With Standard Clinical Assessment for Flap Perfusion in Head and Neck Reconstruction (VISION Trial)","Comparing Intraoperative Indocyanine Green Fluorescence Imaging With Standard Clinical Assessment for Flap Perfusion in Head and Neck Reconstruction: A Randomised Controlled Trial (VISION Trial)","VISION","Inclusion Criteria:\n\n* Age ≥18 years at the time of inclusion\n* Scheduled to undergo microvascular free flap reconstruction as part of oncologic, trauma, or benign surgery in the head and neck area\n* Ability to understand study information and provide written informed consent\n\nExclusion Criteria:\n\n* Known allergy to indocyanine green or iodine\n* Severe hepatic or renal impairment\n* Confirmed or suspected pregnancy\n* Breastfeeding","ALL","18 Years",{"count":72,"type":73},244,"ESTIMATED","INTERVENTIONAL",[76],"PHASE4","This is a prospective multicentre randomised controlled trial evaluating whether intraoperative indocyanine green (ICG) fluorescence angiography improves outcomes in head and neck free flap reconstruction compared with standard clinical assessment of flap perfusion. Adult patients undergoing microvascular free flap reconstruction for oncologic, trauma, or benign head and neck defects will be randomised to either intraoperative ICG angiography or conventional clinical perfusion assessment. The primary outcome is partial flap loss requiring intervention within 30 days after surgery. Secondary outcomes include total flap loss, flap-related re-exploration, flap salvage, and postoperative complications.",[79,80,81,82,23,83,84,85],"Head and Neck Cancer (H&N)","Free Tissue Flaps","Free Flap","Free Flap Evaluation","Indocyanine Green (ICG)","Microsurgery","Randomised Controlled Trial","NOT_YET_RECRUITING","2026-06-08",{"date":89,"type":90},"2026-06-09","ACTUAL",{"date":92,"type":73},"2026-10-01",{"date":94,"type":73},"2029-08-01",{"name":5,"class":6},1]