[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100556347":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":36,"locations":26,"responsibleParty":42,"collaborators":26,"id":45,"slug":46,"hasResults":47,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":51,"eligibilityCriteria":52,"healthyVolunteers":47,"sex":53,"minAge":54,"maxAge":55,"enrollmentInfo":56,"targetDuration":26,"studyType":59,"phases":60,"briefSummary":62,"conditions":63,"keywords":65,"overallStatus":69,"whyStopped":26,"lastUpdateSubmitDate":70,"lastUpdatePostDateStruct":71,"startDateStruct":74,"completionDateStruct":76,"leadSponsor":78,"locationsCount":26},{"fullName":5,"class":6},"University of Cagliari","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"UWsolution","EXPERIMENTAL","Flap preserved in UW solution and cold storage during the ischemia time",[13],"Device: University of Wisconsin solution + cold storage",{"label":15,"type":16,"description":17,"interventionNames":18},"No perfusion","SHAM_COMPARATOR","Flap without perfusion and cold storage",[19],"Other: Unperfused free flap under warm ischemia",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DEVICE","University of Wisconsin solution + cold storage","Preservation of the free flap with UW solution and cold storage during ischemia time",[9],null,{"type":6,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Unperfused free flap under warm ischemia","Traditional processing of the free flap: no perfusion of the flap and warm ischemia (room temperature conservation during ischemia time",[15],[32],{"name":33,"affiliation":34,"role":35},"Adriana Cordova, Prof","University of Palermo","PRINCIPAL_INVESTIGATOR",[37],{"name":38,"role":39,"phone":40,"phoneExt":26,"email":41},"Filippo Boriani, Prof","CONTACT","+393297604660","borianifilippo@gmail.com",{"type":35,"investigatorFullName":43,"investigatorTitle":44,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"Filippo Boriani","Associate Professor","100556347","protecting-autologous-free-flaps-from-ischemiareperfusion-damage-with-cold-storage-100556347",false,"NCT06523920","Protecting Autologous Free Flaps From Ischemia\u002FReperfusion Damage With Cold Storage.","Protecting Autologous Free Flaps From Ischemia\u002FReperfusion Damage With Cold Storage: a Randomized Controlled Trial","PAFFIRD","Inclusion Criteria:\n\n* Post-oncological mandible reconstruction through fibula free flap,\n* Post-oncological soft tissue reconstruction through ALT (Anterior Lateral Thigh) free flap in head and neck region\n* Post-oncological breast reconstruction through DIEP (Deep Inferior Epigastric Perforator) and PAP (Profunda femoris Artery Perforator) free flaps.\n\nExclusion Criteria:\n\n* Malnutrition\n* Malabsorption\n* Vasculitis\n* Pathologies of the connective tissue","ALL","18 Years","85 Years",{"count":57,"type":58},90,"ESTIMATED","INTERVENTIONAL",[61],"NA","Reconstructive microsurgery allows autologous transplantation of flaps. The procedure causes temporary ischemia. The absence of perfusion and the post-anastomosis reperfusion causes ischemia\u002Freperfusion (I\u002FR) damage and an increased percentage of flap complications associated with the longer duration of the ischemia time. In reconstructive surgery the utilization of preservation solution is very limited. The research hypothesis is that cold storage of free flaps might offer benefits. The present study is a RCT to evaluate the feasibility and safety of a cold preservation (using the UW solution) of the free flaps from I\u002FR damage in oncological microsurgical reconstructions. Blood perfusion will be intraoperatively evaluated through indocyanine green and SPY-DHI.\n\nMoreover, patients' outcomes will be evaluated postoperatively through clinical and radiological examinations, particularly focusing on somatosensory recovery and dental rehabilitation after mandibular reconstruction.",[64],"Ischemia Reperfusion Injury",[66,67,68],"free flap","microsurgery","cold ischemia","NOT_YET_RECRUITING","2024-07-23",{"date":72,"type":73},"2024-07-26","ACTUAL",{"date":75,"type":58},"2024-08-01",{"date":77,"type":58},"2026-06-30",{"name":5,"class":6}]