[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100529781":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":12,"centralContacts":27,"locations":12,"responsibleParty":33,"collaborators":36,"id":39,"slug":12,"hasResults":40,"nctId":41,"briefTitle":42,"officialTitle":42,"acronym":43,"eligibilityCriteria":44,"healthyVolunteers":40,"sex":45,"minAge":46,"maxAge":47,"enrollmentInfo":48,"targetDuration":12,"studyType":51,"phases":52,"briefSummary":54,"conditions":55,"keywords":57,"overallStatus":59,"whyStopped":12,"lastUpdateSubmitDate":60,"lastUpdatePostDateStruct":61,"startDateStruct":64,"completionDateStruct":66,"leadSponsor":68,"locationsCount":12},{"fullName":5,"class":6},"St. James's Hospital, Ireland","OTHER",[8,13],{"label":9,"type":10,"description":11,"interventionNames":12},"Standard of care","NO_INTERVENTION","Standard of care post-neck dissection",null,{"label":14,"type":15,"description":16,"interventionNames":17},"Standard of care plus Purabond","EXPERIMENTAL","Standard of care post-neck dissection plus Purabond",[18],"Device: Purabond",[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DEVICE","Purabond","Application of Purabond to surgical field",[14],[26],"RADA16",[28],{"name":29,"role":30,"phone":31,"phoneExt":12,"email":32},"Gerard Sexton","CONTACT","014103000","gerardsexton@rcsi.ie",{"type":34,"investigatorFullName":29,"investigatorTitle":35,"investigatorAffiliation":5,"oldNameTitle":12,"oldOrganization":12},"PRINCIPAL_INVESTIGATOR","Specialist Registrar in Otolaryngology",[37],{"name":38,"class":6},"Royal College of Surgeons, Ireland","100529781",false,"NCT06178237","RADA16 for Reducing Drain Output Trajectory Following Neck Dissection","ROUND","Inclusion Criteria:\n\n* Patients with head and neck cancer (including thyroid, cutaneous, \\& mucosal primaries) for which a neck dissection is indicated as part of treatment.\n* Over 18 years of age.\n* Able to give informed consent.\n\nExclusion Criteria:\n\n* Patients unable to satisfy all the above listed inclusion criteria.","ALL","18 Years","100 Years",{"count":49,"type":50},208,"ESTIMATED","INTERVENTIONAL",[53],"NA","This will be a prospective single-blind randomised controlled trial to evaluate if the use of a medical device named Purabond, a haemostatic agent already CE marked for use in Ireland, can reduce the occurrence of seroma, a complication related to but distinct from haematoma, following neck dissection surgery. Patients undergoing neck dissection surgery will be randomised either to standard post-operative care following neck dissection or to standard post-operative care and Purabond. Drains are placed routinely following surgery of this type and their removal is dictated by the volume of fluid produced per day - it is hypothesised that Purabond will reduce the volume of fluid produced and thereby facilitate earlier drain removal.",[56],"Head and Neck Cancer",[58],"seroma","NOT_YET_RECRUITING","2023-12-11",{"date":62,"type":63},"2023-12-20","ACTUAL",{"date":65,"type":50},"2024-03",{"date":67,"type":50},"2026-06",{"name":5,"class":6}]