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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04647968
Other study ID # 2021-3699
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


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
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