[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100573292":3},{"organization":4,"armGroups":7,"interventions":13,"overallOfficials":10,"centralContacts":19,"locations":26,"responsibleParty":49,"collaborators":10,"id":53,"slug":54,"hasResults":55,"nctId":56,"briefTitle":57,"officialTitle":58,"acronym":10,"eligibilityCriteria":59,"healthyVolunteers":55,"sex":60,"minAge":61,"maxAge":10,"enrollmentInfo":62,"targetDuration":10,"studyType":65,"phases":10,"briefSummary":66,"conditions":67,"keywords":10,"overallStatus":29,"whyStopped":10,"lastUpdateSubmitDate":72,"lastUpdatePostDateStruct":73,"startDateStruct":76,"completionDateStruct":78,"leadSponsor":80,"locationsCount":81},{"fullName":5,"class":6},"University Hospital, Antwerp","OTHER",[8],{"label":9,"type":10,"description":10,"interventionNames":11},"patients with reconstructive flap surgery on upper or lower limb using a fasciocutanous tigh flap",null,[12],"Diagnostic Test: clinical assessments and tissue oxygenation monitoring by Near Infrared Spectroscopy",[14],{"type":15,"name":16,"description":17,"armGroupLabels":18,"otherNames":10},"DIAGNOSTIC_TEST","clinical assessments and tissue oxygenation monitoring by Near Infrared Spectroscopy","Flap failure will be identified, based upon gold standard monitoring (flaps skin color, temperature, tissue turgor and capillary refill time) along with Doppler technique during a postoperative period of five days. In all patients Near Infrared Spectroscopy (NIRS) by FORE-SIGHT ELITE will be applied to obtain continuous tissue oxygenation measurements. NIRS values and trends from patients with flap failure (case group) will be compared to NIRS values and trends from patients with no flap failure(control group).",[9],[20],{"name":21,"role":22,"phone":23,"phoneExt":24,"email":25},"Vera Saldien, MD","CONTACT","38214788","+32","vera.saldien@uza.be",[27],{"facility":28,"status":29,"city":30,"state":31,"zip":32,"country":33,"countryCode":34,"cosmosGeoPoint":35,"geoPoint":40,"contacts":41},"Antwerp University Hospital","RECRUITING","Edegem","Antwerp","2650","Belgium","BE",{"type":36,"coordinates":37},"Point",[38,39],4.44504,51.15662,{"lat":39,"lon":38},[42,45],{"name":43,"role":22,"phone":23,"phoneExt":44,"email":25},"Vera Saldien, MD, PhD","0032",{"name":46,"role":22,"phone":47,"phoneExt":44,"email":48},"Joke De Wachter","38213042","joke.dewachter@uza.be",{"type":50,"investigatorFullName":51,"investigatorTitle":52,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"PRINCIPAL_INVESTIGATOR","Vera Saldien","MD","100573292","anterolateral-tigh-alt-flaps-oxygenation-monitoring-by-nirs-100573292",false,"NCT06744387","Anterolateral Tigh (ALT) Flaps Oxygenation Monitoring by NIRS","Tissue Oxygenation Monitoring of Anterolateral Thigh (ALT) Flaps, Using FORE-SIGHT ELITE Near InfraRed Spectroscopy (NIRS) - A Pilot Study","Inclusion Criteria:\n\n* scheduled for reconstructive flap surgery on either upper or lower limb using a fasciocutaneous anterolateral thigh flap\n\nExclusion Criteria:\n\n* refusal to provide written informed consent.","ALL","18 Years",{"count":63,"type":64},20,"ESTIMATED","OBSERVATIONAL","The goal of this observational study is to conduct postoperative monitoring in patients who have undergone upper or lower limb reconstructive surgery with an anterolateral thigh flap, by employing the gold standard approach: intermittent assessment of clinical parameters (flap's color, temperature, skin turgor and capillary refill time) combined with Doppler techniques, alongside continuous tissue oxygenation measurements obtained using the CASMED FORE-SIGHT ELITE monitor.The main objective of the study is to provide preliminary data on potential cut-off values indicative of flap failure.",[68,69,70,71],"Reconstructive Flap Surgery","Fasciocutaneous Anterolateral Thigh Flap","Postoperative Monitoring","Flap Ischemia","2025-03-04",{"date":74,"type":75},"2025-03-05","ACTUAL",{"date":77,"type":75},"2025-03-03",{"date":79,"type":64},"2026-12-30",{"name":5,"class":6},1]