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

Primary Purpose

Tracheostomy Complication, Post Tracheostomy Complications, Tracheostomy

Status
Recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Primary closure of tracheo-cutaneous fistula
Secondary closure of tracheo-cutaneous fistula
Sponsored by
Université de Sherbrooke
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tracheostomy Complication focused on measuring tracheostomy, tracheostomy closure, tracheocutaneous fistula

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Centre hospitalier universitaire de SherbrookeRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Primary closure of tracheo-cutaneous fistula

Secondary closure of tracheo-cutaneous fistula

Arm Description

This group will undergo a protocoled primary closure of their tracheotomy.

This group will undergo a protocoled secondary closure of their tracheotomy.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Healing time
This outcome will evaluate time until full closure of the wound using both methods of closure.
Respiratory complications
The investigators wish to establish whether there is a difference in respiratory complications occurence between the two means of closure.
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.
Persisting fistula
This outcome intends to evaluate the frequency of persisting fistula using either method of closure.
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.
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.

Full Information

First Posted
November 12, 2020
Last Updated
November 1, 2022
Sponsor
Université de Sherbrooke
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1. Study Identification

Unique Protocol Identification Number
NCT04647968
Brief Title
Primary vs Secondary Closure of Tracheo-cutaneous Fistulas
Acronym
TRACH
Official Title
Primary vs Secondary Closure of Tracheo-cutaneous Fistulas: A Randomized Controlled Study
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
January 12, 2021 (Actual)
Primary Completion Date
January 2024 (Anticipated)
Study Completion Date
March 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Université de Sherbrooke

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tracheostomy Complication, Post Tracheostomy Complications, Tracheostomy
Keywords
tracheostomy, tracheostomy closure, tracheocutaneous fistula

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized Controlled Trial
Masking
None (Open Label)
Masking Description
No masking because it is a surgical procedure
Allocation
Randomized
Enrollment
44 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Primary closure of tracheo-cutaneous fistula
Arm Type
Other
Arm Description
This group will undergo a protocoled primary closure of their tracheotomy.
Arm Title
Secondary closure of tracheo-cutaneous fistula
Arm Type
Other
Arm Description
This group will undergo a protocoled secondary closure of their tracheotomy.
Intervention Type
Procedure
Intervention Name(s)
Primary closure of tracheo-cutaneous fistula
Intervention Description
This procedure will follow protocoled steps. It consists of a sutured closure of the tracheotomy following local anesthesia, done at bedside.
Intervention Type
Procedure
Intervention Name(s)
Secondary closure of tracheo-cutaneous fistula
Intervention Description
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.
Primary Outcome Measure Information:
Title
Patient satisfaction in regards to the scar (change)
Description
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.
Time Frame
1 week, 1 month, 3 months, 6 months
Secondary Outcome Measure Information:
Title
Healing time
Description
This outcome will evaluate time until full closure of the wound using both methods of closure.
Time Frame
6 months
Title
Respiratory complications
Description
The investigators wish to establish whether there is a difference in respiratory complications occurence between the two means of closure.
Time Frame
6 months
Title
Self reported quality of life related to dysphonia (change)
Description
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.
Time Frame
1 week, 1 month, 3 months, 6 months
Title
Persisting fistula
Description
This outcome intends to evaluate the frequency of persisting fistula using either method of closure.
Time Frame
6 months
Title
Self reported quality of life related to dysphagia (change)
Description
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.
Time Frame
1 week, 1 month, 3 months, 6 months
Title
Self reported quality of life related to dyspnea (change)
Description
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.
Time Frame
1 week, 1 month, 3 months, 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Simon Brisebois, MD, MSC
Phone
8193461110
Ext
24947
Email
simon.brisebois@usherbrooke.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Brigitte Routhier-Chevrier, MD
Phone
8193461110
Ext
24947
Email
brigitte.routhier-chevrier@usherbrooke.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Simon Brisebois, MD, MSC
Organizational Affiliation
Université de Sherbrooke
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre hospitalier universitaire de Sherbrooke
City
Sherbrooke
State/Province
Quebec
ZIP/Postal Code
J1G 2E8
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Simon Brisebois, MD MSc
Phone
819-346-1110
Ext
14901
Email
simon.brisebois@usherbrooke.ca
First Name & Middle Initial & Last Name & Degree
Adnan Busuladzic, MD
Phone
819-346-1110
Ext
14901
Email
adnan.busuladzic@usherbrooke.ca
First Name & Middle Initial & Last Name & Degree
Brigitte Routhier-Chevrier, MD

12. IPD Sharing Statement

Plan to Share IPD
No

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Primary vs Secondary Closure of Tracheo-cutaneous Fistulas

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