Tracheostomy ComplicationTRACHNCT04647968
Primary vs Secondary Closure of Tracheo-cutaneous Fistulas
A study testing Primary closure of tracheo-cutaneous fistula and Secondary closure of tracheo-cutaneous fistula in people with Tracheostomy Complication and Post Tracheostomy Complications, run by Université de Sherbrooke at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Tracheostomy Complication, Post Tracheostomy Complications, Tracheostomy
- What is being tested?
- Primary closure of tracheo-cutaneous fistula and Secondary closure of tracheo-cutaneous fistula
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteCanada
- Study dates
- 12 Jan 2021to Jul 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Being covered by the RAMQ
- Having a tracheostomy either percutaneous or surgical
- Being ready for canula removal and closure of the fistula
Who cannot join
- Presenting a contraindication to primary tracheotomy closure (granuloma)
- Unable to consent
- Refusal to participate
Trial locations and contacts
1 site in 1 country.
Brigitte Routhier-Chevrier, MD contact
Canada1 site, 1 recruiting
- Recruiting
Centre hospitalier universitaire de Sherbrooke
Sherbrooke, Quebec, J1G 2E8
Simon Brisebois, MD MSc, 819-346-1110 ext. 14901, simon.brisebois@usherbrooke.ca
Adnan Busuladzic, MD, 819-346-1110 ext. 14901, adnan.busuladzic@usherbrooke.ca
About this study
Official title: 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.
Read the 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.
- Being tested
- Primary closure of tracheo-cutaneous fistula, Secondary closure of tracheo-cutaneous fistula
- Keywords
- tracheostomy, tracheostomy closure, tracheocutaneous fistula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Primary closure of tracheo-cutaneous fistulaProcedure or surgery
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 fistulaProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Primary closure of tracheo-cutaneous fistula | Other | This group will undergo a protocoled primary closure of their tracheotomy. Receives: Procedure: Primary closure of tracheo-cutaneous fistula |
| Secondary closure of tracheo-cutaneous fistula | Other | This group will undergo a protocoled secondary closure of their tracheotomy. Receives: Procedure: Secondary closure of tracheo-cutaneous fistula |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 week, 1 month, 3 months, 6 months
Secondary outcomes (6)
Healing time
This outcome will evaluate time until full closure of the wound using both methods of closure.
Measured: 6 months
Respiratory complications
The investigators wish to establish whether there is a difference in respiratory complications occurence between the two means of closure.
Measured: 6 months
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.
Measured: 1 week, 1 month, 3 months, 6 months
Persisting fistula
This outcome intends to evaluate the frequency of persisting fistula using either method of closure.
Measured: 6 months
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.
Measured: 1 week, 1 month, 3 months, 6 months
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.
Measured: 1 week, 1 month, 3 months, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2020
- Study start12 Jan 2021
- Primary completionJan 2026 (estimated)
- Study completionJul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tracheostomy ComplicationStudies of the same condition, open and under way.
- More trials run by Université de SherbrookeThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized Controlled Trial
- Masking
- None (open label)
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Université de Sherbrooke
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Simon Brisebois, Université de Sherbrooke
- Investigators
- Simon Brisebois, MD, MSC, Principal investigator, Université de Sherbrooke
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04647968
- Sponsor's protocol ID
- 2021-3699
- Acronym
- TRACH
- Status last verified
- Jul 2024
- First submitted
- 12 Nov 2020
- Last updated
- 23 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Primary vs Secondary Closure of Tracheo-cutaneous Fistulas: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT04647968
- Acronym / sponsor ID
- TRACH / 2021-3699
- Keywords
- tracheostomy, tracheostomy closure, tracheocutaneous fistula
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- Université de SherbrookeUniversity, hospital or other
- Study start
- 12 Jan 2021 (actual)
- Primary completion
- Jan 2026 (estimated)
- Study completion
- Jul 2026 (estimated)
- First posted
- 1 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized Controlled Trial
| Arm | Type | Receives |
|---|---|---|
| Primary closure of tracheo-cutaneous fistula | Other | Procedure: Primary closure of tracheo-cutaneous fistulaThis group will undergo a protocoled primary closure of their tracheotomy. |
| Secondary closure of tracheo-cutaneous fistula | Other | Procedure: Secondary closure of tracheo-cutaneous fistulaThis group will undergo a protocoled secondary closure of their tracheotomy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Being covered by the RAMQ
- Having a tracheostomy either percutaneous or surgical
- Being ready for canula removal and closure of the fistula
Key exclusion criteria (3 listed)
- Presenting a contraindication to primary tracheotomy closure (granuloma)
- Unable to consent
- Refusal to participate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Primary closure of tracheo-cutaneous fistulaThis procedure will follow protocoled steps. It consists of a sutured closure of the tracheotomy following local anesthesia, done at bedside. | Procedure or surgery | Primary closure of tracheo-cutaneous fistula |
| Secondary closure of tracheo-cutaneous fistulaThis 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. | Procedure or surgery | Secondary closure of tracheo-cutaneous fistula |
Primary outcome
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.
6 secondary outcomes
Healing time
Time frame: 6 months
Respiratory complications
Time frame: 6 months
Self reported quality of life related to dysphonia (change)
Time frame: 1 week, 1 month, 3 months, 6 months
Persisting fistula
Time frame: 6 months
Self reported quality of life related to dysphagia (change)
Time frame: 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Brigitte Routhier-Chevrier, MD contact
Simon Brisebois, MD, MSC principal investigator
Université de Sherbrooke
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Primary closure of tracheo-cutaneous fistula and Secondary closure of tracheo-cutaneous fistula in people with Tracheostomy Complication and Post Tracheostomy Complications, run by Université de Sherbrooke at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Simon Brisebois, MD, MSC (8193461110 ext. 24947, simon.brisebois@usherbrooke.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient satisfaction in regards to the scar (change) (time frame: 1 week, 1 month, 3 months, 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2024.