Primary vs Secondary Closure of Tracheo-cutaneous Fistulas

Tracheostomy Clinical Trial

— TRACH  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04647968
• Other study ID #: 2021-3699
• Status: Recruiting
• Phase: N/A
• Start date: January 12, 2021
• Est. completion date: March 2024

Study information

• Verified date: November 2022
• Source: Université de Sherbrooke
• Contact: Simon Brisebois, MD, MSC
• Phone: 8193461110
• Email: simon.brisebois[@]usherbrooke.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 44
• Est. completion date: March 2024
• Est. primary completion date: January 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cutaneous Fistula
• Fistula
• Post Tracheostomy Complications
• Postoperative Complications
• Tracheostomy
• Tracheostomy Complication

Intervention

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.
• 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.

Locations

Country	Name	City	State
Canada	Centre hospitalier universitaire de Sherbrooke	Sherbrooke	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
Université de Sherbrooke

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient satisfaction in regards to the scar (change)	This outcome will evaluate patient satisfaction in regards to his tracheotomy scar following closure, measured with the Patient observer scar assesment scale (POSAS) validated questionnaire. A high score means a worse outcome.	1 week, 1 month, 3 months, 6 months
Secondary	Healing time	This outcome will evaluate time until full closure of the wound using both methods of closure.	6 months
Secondary	Respiratory complications	The investigators wish to establish whether there is a difference in respiratory complications occurence between the two means of closure.	6 months
Secondary	Self reported quality of life related to dysphonia (change)	The goal of this outcome is to evaluate the self reported quality of life of patients following tracheotomy closed by either mean. The investigators are going to use the Voice Handicap Index (VHI-10) validated questionnaire to better assess this outcome. A high score means a worse outcome, the highest score being 40.	1 week, 1 month, 3 months, 6 months
Secondary	Persisting fistula	This outcome intends to evaluate the frequency of persisting fistula using either method of closure.	6 months
Secondary	Self reported quality of life related to dysphagia (change)	The goal of this outcome is to evaluate the self reported quality of life of patients following tracheotomy closed by either mean. We are going to use the EAT-10 validated questionnaire to better assess this outcome. A high score means a worse outcome, the highest score being 40.	1 week, 1 month, 3 months, 6 months
Secondary	Self reported quality of life related to dyspnea (change)	The goal of this outcome is to evaluate the self reported quality of life of patients following tracheotomy closed by either mean. This will be measure by the Dyspnea Index (DI) validated questionnaire but also with the follow-up history. The Dyspnea Index questionnaire has a maximum score of 40. A high score means a worse outcome.	1 week, 1 month, 3 months, 6 months