[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100412239":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":27,"centralContacts":31,"locations":40,"responsibleParty":65,"collaborators":23,"id":68,"slug":69,"hasResults":70,"nctId":71,"briefTitle":72,"officialTitle":73,"acronym":74,"eligibilityCriteria":75,"healthyVolunteers":76,"sex":77,"minAge":78,"maxAge":23,"enrollmentInfo":79,"targetDuration":23,"studyType":82,"phases":83,"briefSummary":85,"conditions":86,"keywords":90,"overallStatus":43,"whyStopped":23,"lastUpdateSubmitDate":94,"lastUpdatePostDateStruct":95,"startDateStruct":98,"completionDateStruct":100,"leadSponsor":102,"locationsCount":103},{"fullName":5,"class":6},"Université de Sherbrooke","OTHER",[8,13],{"label":9,"type":6,"description":10,"interventionNames":11},"Primary closure of tracheo-cutaneous fistula","This group will undergo a protocoled primary closure of their tracheotomy.",[12],"Procedure: Primary closure of tracheo-cutaneous fistula",{"label":14,"type":6,"description":15,"interventionNames":16},"Secondary closure of tracheo-cutaneous fistula","This group will undergo a protocoled secondary closure of their tracheotomy.",[17],"Procedure: Secondary closure of tracheo-cutaneous fistula",[19,24],{"type":20,"name":9,"description":21,"armGroupLabels":22,"otherNames":23},"PROCEDURE","This procedure will follow protocoled steps. It consists of a sutured closure of the tracheotomy following local anesthesia, done at bedside.",[9],null,{"type":20,"name":14,"description":25,"armGroupLabels":26,"otherNames":23},"This procedure will follow protocoled steps. It consists of removing the tracheotomy canula and applying ointment and an Elastoplast on the site, which will be changed regularly until full healing of the wound.",[14],[28],{"name":29,"affiliation":5,"role":30},"Simon Brisebois, MD, MSC","PRINCIPAL_INVESTIGATOR",[32,37],{"name":29,"role":33,"phone":34,"phoneExt":35,"email":36},"CONTACT","8193461110","24947","simon.brisebois@usherbrooke.ca",{"name":38,"role":33,"phone":34,"phoneExt":35,"email":39},"Brigitte Routhier-Chevrier, MD","brigitte.routhier-chevrier@usherbrooke.ca",[41],{"facility":42,"status":43,"city":44,"state":45,"zip":46,"country":47,"countryCode":48,"cosmosGeoPoint":49,"geoPoint":54,"contacts":55},"Centre hospitalier universitaire de Sherbrooke","RECRUITING","Sherbrooke","Quebec","J1G 2E8","Canada","CA",{"type":50,"coordinates":51},"Point",[52,53],-71.89908,45.40008,{"lat":53,"lon":52},[56,60,63],{"name":57,"role":33,"phone":58,"phoneExt":59,"email":36},"Simon Brisebois, MD MSc","819-346-1110","14901",{"name":61,"role":33,"phone":58,"phoneExt":59,"email":62},"Adnan Busuladzic, MD","adnan.busuladzic@usherbrooke.ca",{"name":38,"role":64,"phone":23,"phoneExt":23,"email":23},"SUB_INVESTIGATOR",{"type":30,"investigatorFullName":66,"investigatorTitle":67,"investigatorAffiliation":5,"oldNameTitle":23,"oldOrganization":23},"Simon Brisebois","Assistant Professor - Division of Otolaryngology - Head & Neck Surgery","100412239","primary-vs-secondary-closure-of-tracheo-cutaneous-fistulas-100412239",false,"NCT04647968","Primary vs Secondary Closure of Tracheo-cutaneous Fistulas","Primary vs Secondary Closure of Tracheo-cutaneous Fistulas: A Randomized Controlled Study","TRACH","Inclusion Criteria:\n\n* Being covered by the RAMQ\n* Having a tracheostomy either percutaneous or surgical\n* Being ready for canula removal and closure of the fistula\n\nExclusion Criteria:\n\n* Presenting a contraindication to primary tracheotomy closure (granuloma)\n* Unable to consent\n* Refusal to participate",true,"ALL","18 Years",{"count":80,"type":81},44,"ESTIMATED","INTERVENTIONAL",[84],"NA","The mean of this study is to compare primary and secondary closure of tracheo-cutaneous fistulas and evaluate the differences in outcomes between both techniques.",[87,88,89],"Tracheostomy Complication","Post Tracheostomy Complications","Tracheostomy",[91,92,93],"tracheostomy","tracheostomy closure","tracheocutaneous fistula","2024-07-22",{"date":96,"type":97},"2024-07-23","ACTUAL",{"date":99,"type":97},"2021-01-12",{"date":101,"type":81},"2026-07",{"name":5,"class":6},1]