NCT04647968

Primary vs Secondary Closure of Tracheo-cutaneous Fistulas

Primary vs Secondary Closure of Tracheo-cutaneous Fistulas: A Randomized Controlled Study

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 44 (estimated)
• Sponsor: Université de Sherbrooke · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Tracheostomy Complication
• Post Tracheostomy Complications
• Tracheostomy

Interventions

Type	Name	Description
PROCEDURE	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.
PROCEDURE	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.

Timeline

• Start date: 2021-01-12
• Primary completion: 2026-01-01
• Completion: 2026-07-01
• First posted: 2020-12-01
• Last updated: 2024-07-23

Locations

1 site across 1 country: Canada