NCT Number: NCT04647968
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Sherbrooke, Quebec, J1G 2E8, Canada
Location status: Recruiting
Adnan Busuladzic, MD
CONTACT
819-346-1110 ext. 14901
Brigitte Routhier-Chevrier, MD
SUB_INVESTIGATOR
Simon Brisebois, MD MSc
CONTACT
819-346-1110 ext. 14901
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
Time frame: 6 months
This outcome will evaluate time until full closure of the wound using both methods of closure.
Time frame: 6 months
The investigators wish to establish whether there is a difference in respiratory complications occurence between the two means of closure.
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.
Time frame: 6 months
This outcome intends to evaluate the frequency of persisting fistula using either method of closure.
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.
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.
Contact information is provided by the study sponsor or research team.
Brigitte Routhier-Chevrier, MD
CONTACT
8193461110 ext. 24947
Simon Brisebois, MD, MSC
CONTACT
8193461110 ext. 24947
Université de Sherbrooke
Other
Primary vs Secondary Closure of Tracheo-cutaneous Fistulas: A Randomized Controlled Study
Acronym: TRACH
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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