Primary vs Secondary Closure of Tracheo-cutaneous Fistulas

Not Applicable

Recruiting

• Conditions: Tracheostomy Complication; Post Tracheostomy Complications; Tracheostomy

• Registration Number: NCT04647968
• Lead Sponsor: Université de Sherbrooke

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2020-11-12
• Study First Submitted QC: 2020-11-23
• Study First Posted: 2020-12-01
• Study Start: 2021-01-12
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-22
• Last Update Posted: 2024-07-23
• Primary Completion: 2026-01
• Study Completion: 2026-07

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 44

Inclusion Criteria

• Being covered by the RAMQ
• Having a tracheostomy either percutaneous or surgical
• Being ready for canula removal and closure of the fistula

Exclusion Criteria

• Presenting a contraindication to primary tracheotomy closure (granuloma)
• Unable to consent
• Refusal to participate

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Patient satisfaction in regards to the scar (change)	1 week, 1 month, 3 months, 6 months	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.

Secondary Outcome Measures

Name	Time	Method
Healing time	6 months	This outcome will evaluate time until full closure of the wound using both methods of closure.
Self reported quality of life related to dysphagia (change)	1 week, 1 month, 3 months, 6 months	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.
Persisting fistula	6 months	This outcome intends to evaluate the frequency of persisting fistula using either method of closure.
Self reported quality of life related to dyspnea (change)	1 week, 1 month, 3 months, 6 months	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.
Respiratory complications	6 months	The investigators wish to establish whether there is a difference in respiratory complications occurence between the two means of closure.
Self reported quality of life related to dysphonia (change)	1 week, 1 month, 3 months, 6 months	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.

Trial Locations

Locations (1)

Centre hospitalier universitaire de Sherbrooke; 🇨🇦 Sherbrooke, Quebec, Canada