Recruiting

Primary vs. Secondary Closure

Sponsor:

Université de Sherbrooke

Code:

NCT04647968

Conditions

Tracheostomy Complication

Post Tracheostomy Complications

Tracheostomy

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Primary closure of tracheo-cutaneous fistula

Secondary closure of tracheo-cutaneous fistula

Study Details

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.

Conditions

Tracheostomy Complication

Post Tracheostomy Complications

Tracheostomy

Study ID

NCT04647968

Start date

Jan 12, 2021

Status verified date

Jul, 2024

Completion date

Jul, 2026

Anticipated

Primary completion date

Jan, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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

Enrollment

44 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

other: Primary closure of tracheo-cutaneous fistula

This group will undergo a protocoled primary closure of their tracheotomy.

other: Secondary closure of tracheo-cutaneous fistula

This group will undergo a protocoled secondary closure of their tracheotomy.

Interventions

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.

Primary outcome measure

  • Patient satisfaction in regards to the scar (change) [ Time Frame: 1 week, 1 month, 3 months, 6 months ]

Central Contacts and Locations

Central contacts

Simon Brisebois, MD, MSC

8193461110simon.brisebois@usherbrooke.ca

Brigitte Routhier-Chevrier, MD

8193461110brigitte.routhier-chevrier@usherbrooke.ca

Locations

Centre hospitalier universitaire de Sherbrooke

Recruiting

Sherbrooke, Quebec, Canada, J1G 2E8

Contacts

Simon Brisebois, MD MSc

819-346-1110simon.brisebois@usherbrooke.ca

Adnan Busuladzic, MD

819-346-1110adnan.busuladzic@usherbrooke.ca

More Information

Sponsor

Université de Sherbrooke

Last update posted

Jul 23, 2024

Last verified

Jul, 2024

Keywords

  • tracheostomy
  • tracheostomy closure
  • tracheocutaneous fistula

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Université de Sherbrooke on 2024-07-23.