Primary vs Secondary Closure of Tracheo-cutaneous Fistulas
NCT ID: NCT04647968
Last Updated: 2024-07-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
44 participants
INTERVENTIONAL
2021-01-12
2026-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Primary closure of tracheo-cutaneous fistula
This group will undergo a protocoled primary closure of their tracheotomy.
Primary closure of tracheo-cutaneous fistula
This procedure will follow protocoled steps. It consists of a sutured closure of the tracheotomy following local anesthesia, done at bedside.
Secondary closure of tracheo-cutaneous fistula
This group will undergo a protocoled secondary closure of their tracheotomy.
Secondary closure of tracheo-cutaneous fistula
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.
Interventions
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Primary closure of tracheo-cutaneous fistula
This procedure will follow protocoled steps. It consists of a sutured closure of the tracheotomy following local anesthesia, done at bedside.
Secondary closure of tracheo-cutaneous fistula
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.
Eligibility Criteria
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Inclusion Criteria
* Having a tracheostomy either percutaneous or surgical
* Being ready for canula removal and closure of the fistula
Exclusion Criteria
* Unable to consent
* Refusal to participate
18 Years
ALL
Yes
Sponsors
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Université de Sherbrooke
OTHER
Responsible Party
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Simon Brisebois
Assistant Professor - Division of Otolaryngology - Head & Neck Surgery
Principal Investigators
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Simon Brisebois, MD, MSC
Role: PRINCIPAL_INVESTIGATOR
Université de Sherbrooke
Locations
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Centre hospitalier universitaire de Sherbrooke
Sherbrooke, Quebec, Canada
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2021-3699
Identifier Type: -
Identifier Source: org_study_id
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