Ignite Creation Date:
2025-12-24 @ 5:48 PM
Ignite Modification Date:
2025-12-29 @ 7:55 AM
Study NCT ID:
NCT04647968
Status:
RECRUITING
Last Update Posted:
2024-07-23
First Post:
2020-11-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Primary vs Secondary Closure of Tracheo-cutaneous Fistulas
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'No masking because it is a surgical procedure'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomized Controlled Trial'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 44}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-01-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2026-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-07-22', 'studyFirstSubmitDate': '2020-11-12', 'studyFirstSubmitQcDate': '2020-11-23', 'lastUpdatePostDateStruct': {'date': '2024-07-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-12-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Patient satisfaction in regards to the scar (change)', 'timeFrame': '1 week, 1 month, 3 months, 6 months', 'description': 'This outcome will evaluate patient satisfaction in regards to his tracheotomy scar following closure, measured with the Patient observer scar assesment scale (POSAS) validated questionnaire. A high score means a worse outcome.'}], 'secondaryOutcomes': [{'measure': 'Healing time', 'timeFrame': '6 months', 'description': 'This outcome will evaluate time until full closure of the wound using both methods of closure.'}, {'measure': 'Respiratory complications', 'timeFrame': '6 months', 'description': 'The investigators wish to establish whether there is a difference in respiratory complications occurence between the two means of closure.'}, {'measure': 'Self reported quality of life related to dysphonia (change)', 'timeFrame': '1 week, 1 month, 3 months, 6 months', 'description': 'The goal of this outcome is to evaluate the self reported quality of life of patients following tracheotomy closed by either mean. The investigators are going to use the Voice Handicap Index (VHI-10) validated questionnaire to better assess this outcome. A high score means a worse outcome, the highest score being 40.'}, {'measure': 'Persisting fistula', 'timeFrame': '6 months', 'description': 'This outcome intends to evaluate the frequency of persisting fistula using either method of closure.'}, {'measure': 'Self reported quality of life related to dysphagia (change)', 'timeFrame': '1 week, 1 month, 3 months, 6 months', 'description': 'The goal of this outcome is to evaluate the self reported quality of life of patients following tracheotomy closed by either mean. We are going to use the EAT-10 validated questionnaire to better assess this outcome. A high score means a worse outcome, the highest score being 40.'}, {'measure': 'Self reported quality of life related to dyspnea (change)', 'timeFrame': '1 week, 1 month, 3 months, 6 months', 'description': 'The goal of this outcome is to evaluate the self reported quality of life of patients following tracheotomy closed by either mean. This will be measure by the Dyspnea Index (DI) validated questionnaire but also with the follow-up history. The Dyspnea Index questionnaire has a maximum score of 40. A high score means a worse outcome.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['tracheostomy', 'tracheostomy closure', 'tracheocutaneous fistula'], 'conditions': ['Tracheostomy Complication', 'Post Tracheostomy Complications', 'Tracheostomy']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': 'In this study the investigators wish to recruit patients with a tracheotomy that has been installed for various reasons and that is ready for closure. The investigators intend to randomly allocate them a mean of closure, either primary or secondary. Once the fistula is closed, the investigators will follow them over a substantial period of time to compare outcomes of each mean of closing. Different questionnaires will be used to best evaluate a range of variables.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': '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'}, 'identificationModule': {'nctId': 'NCT04647968', 'acronym': 'TRACH', 'briefTitle': 'Primary vs Secondary Closure of Tracheo-cutaneous Fistulas', 'organization': {'class': 'OTHER', 'fullName': 'Université de Sherbrooke'}, 'officialTitle': 'Primary vs Secondary Closure of Tracheo-cutaneous Fistulas: A Randomized Controlled Study', 'orgStudyIdInfo': {'id': '2021-3699'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Primary closure of tracheo-cutaneous fistula', 'description': 'This group will undergo a protocoled primary closure of their tracheotomy.', 'interventionNames': ['Procedure: Primary closure of tracheo-cutaneous fistula']}, {'type': 'OTHER', 'label': 'Secondary closure of tracheo-cutaneous fistula', 'description': 'This group will undergo a protocoled secondary closure of their tracheotomy.', 'interventionNames': ['Procedure: Secondary closure of tracheo-cutaneous fistula']}], 'interventions': [{'name': 'Primary closure of tracheo-cutaneous fistula', 'type': 'PROCEDURE', 'description': 'This procedure will follow protocoled steps. It consists of a sutured closure of the tracheotomy following local anesthesia, done at bedside.', 'armGroupLabels': ['Primary closure of tracheo-cutaneous fistula']}, {'name': 'Secondary closure of tracheo-cutaneous fistula', 'type': 'PROCEDURE', 'description': '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.', 'armGroupLabels': ['Secondary closure of tracheo-cutaneous fistula']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'J1G 2E8', 'city': 'Sherbrooke', 'state': 'Quebec', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Simon Brisebois, MD MSc', 'role': 'CONTACT', 'email': 'simon.brisebois@usherbrooke.ca', 'phone': '819-346-1110', 'phoneExt': '14901'}, {'name': 'Adnan Busuladzic, MD', 'role': 'CONTACT', 'email': 'adnan.busuladzic@usherbrooke.ca', 'phone': '819-346-1110', 'phoneExt': '14901'}, {'name': 'Brigitte Routhier-Chevrier, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Centre hospitalier universitaire de Sherbrooke', 'geoPoint': {'lat': 45.40008, 'lon': -71.89908}}], 'centralContacts': [{'name': 'Simon Brisebois, MD, MSC', 'role': 'CONTACT', 'email': 'simon.brisebois@usherbrooke.ca', 'phone': '8193461110', 'phoneExt': '24947'}, {'name': 'Brigitte Routhier-Chevrier, MD', 'role': 'CONTACT', 'email': 'brigitte.routhier-chevrier@usherbrooke.ca', 'phone': '8193461110', 'phoneExt': '24947'}], 'overallOfficials': [{'name': 'Simon Brisebois, MD, MSC', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Université de Sherbrooke'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Université de Sherbrooke', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor - Division of Otolaryngology - Head & Neck Surgery', 'investigatorFullName': 'Simon Brisebois', 'investigatorAffiliation': 'Université de Sherbrooke'}}}}