RecruitingNot ApplicableNCT04647968

Primary vs Secondary Closure of Tracheo-cutaneous Fistulas

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


Sponsor

Université de Sherbrooke

Enrollment

44 participants

Start Date

Jan 12, 2021

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study compares two methods of closing a tracheostomy site — the hole in the throat left after a breathing tube (tracheostomy cannula) is removed. One method is primary closure, where the wound is surgically stitched closed. The other is secondary (natural) closure, where the wound is left to heal on its own. Both are used in practice, but it is not yet clear which produces better outcomes in terms of healing time, scarring, and complications. Patients whose tracheostomy is ready to be removed will be randomly assigned to one of the two closure methods, and their healing will be monitored over time. **You may be eligible if you:** - Are covered by RAMQ (Quebec's provincial health insurance) - Have had a tracheostomy (either percutaneous or surgical) - Are clinically ready to have the cannula removed and the tracheostomy site closed **You may NOT be eligible if you:** - Have a contraindication to primary tracheostomy closure (such as granuloma tissue formation at the site) - Are unable to provide informed consent - Do not wish to participate **Talk to your doctor** if you are approaching the stage of tracheostomy removal and want to understand your options for wound closure.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

PROCEDUREPrimary 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.

PROCEDURESecondary 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.


Locations(1)

Centre hospitalier universitaire de Sherbrooke

Sherbrooke, Quebec, Canada

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT04647968


Related Trials