An interventional study of Primary closure of tracheo-cutaneous fistula and Secondary closure of tracheo-cutaneous fistula in Tracheostomy Complication, Post Tracheostomy Complications and Tracheostomy, sponsored by Université de Sherbrooke. Recruiting at 1 site in Canada. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-07-23.
Sponsored by Université de Sherbrooke · Not applicable, Interventional, and Treatment
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.
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.
731 studies on the registry are indexed under Fistula; 103 are open to participants now.
This study's planned enrollment of 44 is below the median of 60 across 484 interventional studies indexed under Fistula.
Browse Fistula studies →Université de Sherbrooke is the lead sponsor of 289 studies on the registry; 68 are open to participants now.
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Exclusion Criteria:
This group will undergo a protocoled primary closure of their tracheotomy.
Procedure: Primary 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 a sutured closure of the tracheotomy following local anesthesia, done at bedside.
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.
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.
Time frame: 1 week, 1 month, 3 months, 6 months
Healing time
This outcome will evaluate time until full closure of the wound using both methods of closure.
Time frame: 6 months
Respiratory complications
The investigators wish to establish whether there is a difference in respiratory complications occurence between the two means of closure.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 1 week, 1 month, 3 months, 6 months
Plan to share: No
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Cutaneous Fistula
Université de Sherbrooke