Actively Recruiting
Primary vs Secondary Closure of Tracheo-cutaneous Fistulas: A Randomized Controlled Study
Led by Université de Sherbrooke · Updated on 2024-07-23
44
Participants Needed
1
Research Sites
25 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are comparing two methods for closing tracheo-cutaneous fistulas in patients who have had a tracheotomy placed for various reasons and are now ready for closure. The study aims to evaluate differences in outcomes between primary closure, where the tracheotomy is sutured closed, and secondary closure, where the wound is allowed to heal naturally with ointment and dressings. This randomized controlled study is sponsored by Université de Sherbrooke and focuses on patient satisfaction and healing results. Participants will be randomly assigned to one of two groups: primary closure or secondary closure of their tracheotomy site. The primary closure involves a sutured procedure done at the bedside under local anesthesia following a set protocol. The secondary closure involves removing the tracheotomy cannula and regularly applying ointment and Elastoplast dressings until the wound heals fully. Both groups will be closely monitored throughout the healing process. During the study, participants will be followed for up to six months with evaluations at multiple time points including 1 week, 1 month, 3 months, and 6 months. Various questionnaires will assess patient satisfaction with the scar, quality of life related to voice, swallowing, and breathing changes, as well as tracking healing time, respiratory complications, and any persisting fistula. The study aims to provide comprehensive data on the effects of each closure technique over time.
CONDITIONS
Brief Title
Primary vs Secondary Closure of Tracheo-cutaneous Fistulas
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Being covered by the RAMQ
- Having a tracheostomy either percutaneous or surgical
- Being ready for cannula removal and closure of the fistula
- Age 18 years or older
You will not qualify if you...
- Presenting a contraindication to primary tracheotomy closure (granuloma)
- Unable to consent
- Refusal to participate
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Until wound closure or up to 6 months
Participants undergo either a primary or secondary closure of their tracheo-cutaneous fistula. Primary closure involves a sutured closure at bedside under local anesthesia, while secondary closure involves removal of the tracheotomy cannula with regular ointment and dressing changes until healing.
1 procedure visit followed by regular wound care visits until healing
Duration - 6 months
Participants are followed for up to 6 months after closure to assess healing, respiratory complications, quality of life related to dysphonia, dysphagia, dyspnea, and patient satisfaction with the scar.
Visits at 1 week, 1 month, 3 months, and 6 months post-closure
Trial Site Locations
Total: 1 location
1
Centre hospitalier universitaire de Sherbrooke
Sherbrooke, Quebec, Canada, J1G 2E8
Actively Recruiting
Research Team
S
Simon Brisebois, MD, MSC
B
Brigitte Routhier-Chevrier, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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