Primary vs Secondary Closure of Tracheo-cutaneous Fistulas (TRACH)

November 1, 2022 updated by: Simon Brisebois, Université de Sherbrooke

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Anticipated)

44

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Canada
    • Quebec
      • Sherbrooke, Quebec, Canada, J1G 2E8
        • Recruiting
        • Centre Hospitalier Universitaire de Sherbrooke
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Brigitte Routhier-Chevrier, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Primary closure of tracheo-cutaneous fistula
This group will undergo a protocoled primary closure of their tracheotomy.
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.
Other: Secondary closure of tracheo-cutaneous fistula
This group will undergo a protocoled secondary closure of their tracheotomy.
Procedure: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient satisfaction in regards to the scar (change)
Time Frame: 1 week, 1 month, 3 months, 6 months
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Healing time
Time Frame: 6 months
This outcome will evaluate time until full closure of the wound using both methods of closure.
6 months
Respiratory complications
Time Frame: 6 months
The investigators wish to establish whether there is a difference in respiratory complications occurence between the two means of closure.
6 months
Self reported quality of life related to dysphonia (change)
Time Frame: 1 week, 1 month, 3 months, 6 months
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
Persisting fistula
Time Frame: 6 months
This outcome intends to evaluate the frequency of persisting fistula using either method of closure.
6 months
Self reported quality of life related to dysphagia (change)
Time Frame: 1 week, 1 month, 3 months, 6 months
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
Self reported quality of life related to dyspnea (change)
Time Frame: 1 week, 1 month, 3 months, 6 months
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Université de Sherbrooke

Investigators

  • Principal Investigator: Simon Brisebois, MD, MSC, Université de Sherbrooke

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 12, 2021

Primary Completion (Anticipated)

January 1, 2024

Study Completion (Anticipated)

March 1, 2024

Study Registration Dates

First Submitted

November 12, 2020

First Submitted That Met QC Criteria

November 23, 2020

First Posted (Actual)

December 1, 2020

Study Record Updates

Last Update Posted (Actual)

November 3, 2022

Last Update Submitted That Met QC Criteria

November 1, 2022

Last Verified

November 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2021-3699

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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