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NCT Number: NCT04647968

Primary vs Secondary Closure of Tracheo-cutaneous Fistulas

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.

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Key information

Conditions

Tracheostomy Complication Post Tracheostomy Complications Tracheostomy

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre hospitalier universitaire de Sherbrooke

Sherbrooke, Quebec, J1G 2E8, Canada

Location status: Recruiting

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary closure of tracheo-cutaneous fistula

Procedure

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

Procedure

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 outcomes

  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 outcomes

  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.

Interested in participating?

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Sponsors and collaborators

Lead sponsor

Université de Sherbrooke

Other

Registry information

Official study title

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

Acronym: TRACH

Important dates

Study start
2021
Primary completion
2026
Study completion
2026
First posted
Dec 1, 2020
Registry last updated
Jul 23, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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