Comparing two methods for closing tracheo-cutaneous fistulas
Primary vs Secondary Closure of Tracheo-cutaneous Fistulas: A Randomized Controlled Study
This study is testing two different ways to close tracheo-cutaneous fistulas in patients who have had a tracheostomy to see which method helps them heal better.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 44 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Université de Sherbrooke Academic / other |
| Locations | 1 site (Sherbrooke, Quebec) |
| Trial ID | NCT04647968 on ClinicalTrials.gov |
What this trial studies
This study aims to compare the outcomes of primary versus secondary closure techniques for tracheo-cutaneous fistulas in patients who have undergone tracheostomy. Participants will be randomly assigned to one of the two closure methods and will be monitored over time to assess the effectiveness and recovery associated with each technique. Various questionnaires will be utilized to evaluate a range of outcomes related to the closure process. The goal is to determine which method yields better results for patients preparing for tracheostomy closure.
Who should consider this trial
Good fit: Ideal candidates are patients with a tracheostomy who are ready for canula removal and closure of the fistula.
Not a fit: Patients with contraindications to primary closure, such as granuloma, or those unable to consent will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved closure techniques for tracheo-cutaneous fistulas, enhancing patient recovery and outcomes.
How similar studies have performed: While there may be existing studies on tracheostomy closure, this specific comparison of primary versus secondary closure techniques is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Sherbrooke, Quebec
- Centre hospitalier universitaire de Sherbrooke — Sherbrooke, Quebec, Canada (Recruiting)
Study contacts
- Principal investigator: Simon Brisebois, MD, MSC — Université de Sherbrooke
- Study coordinator: Simon Brisebois, MD, MSC
- Email: simon.brisebois@usherbrooke.ca
- Phone: 8193461110
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.