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

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ClinicalTrials.gov Identifier: NCT04647968
Recruitment Status : Recruiting
First Posted : December 1, 2020
Last Update Posted : June 18, 2021
Sponsor:
Information provided by (Responsible Party):
Simon Brisebois, Université de Sherbrooke

Study Description
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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.

Condition or disease Intervention/treatment Phase
Tracheostomy Complication Post Tracheostomy Complications Tracheostomy Procedure: Primary closure of tracheo-cutaneous fistula Procedure: Secondary closure of tracheo-cutaneous fistula Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 44 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized Controlled Trial
Masking: None (Open Label)
Masking Description: No masking because it is a surgical procedure
Primary Purpose: Treatment
Official Title: Primary vs Secondary Closure of Tracheo-cutaneous Fistulas: A Randomized Controlled Study
Actual Study Start Date : January 12, 2021
Estimated Primary Completion Date : September 2022
Estimated Study Completion Date : October 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fistulas

Arms and Interventions
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Arm Intervention/treatment
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.
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.


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Healing time [ Time Frame: 6 months ]
    This outcome will evaluate time until full closure of the wound using both methods of closure.

  2. 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.

  3. 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.

  4. Persisting fistula [ Time Frame: 6 months ]
    This outcome intends to evaluate the frequency of persisting fistula using either method of closure.

  5. 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.

  6. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04647968


Contacts
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Contact: Simon Brisebois, MD, MSC 8193461110 ext 24947 simon.brisebois@usherbrooke.ca
Contact: Brigitte Routhier-Chevrier, MD 8193461110 ext 24947 brigitte.routhier-chevrier@usherbrooke.ca

Locations
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Canada, Quebec
Centre hospitalier universitaire de Sherbrooke Recruiting
Sherbrooke, Quebec, Canada, J1G 2E8
Contact: Simon Brisebois, MD MSc    819-346-1110 ext 14901    simon.brisebois@usherbrooke.ca   
Contact: Adnan Busuladzic, MD    819-346-1110 ext 14901    adnan.busuladzic@usherbrooke.ca   
Sub-Investigator: Brigitte Routhier-Chevrier, MD         
Sponsors and Collaborators
Université de Sherbrooke
Investigators
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Principal Investigator: Simon Brisebois, MD, MSC Université de Sherbrooke
More Information
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Responsible Party: Simon Brisebois, Assistant Professor - Division of Otolaryngology - Head & Neck Surgery, Université de Sherbrooke
ClinicalTrials.gov Identifier: NCT04647968    
Other Study ID Numbers: 2021-3699
First Posted: December 1, 2020    Key Record Dates
Last Update Posted: June 18, 2021
Last Verified: June 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Simon Brisebois, Université de Sherbrooke:
tracheostomy
tracheostomy closure
tracheocutaneous fistula
Additional relevant MeSH terms:
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Cutaneous Fistula
Fistula
Postoperative Complications
 Pathological Conditions, Anatomical
Pathologic Processes
Skin Diseases