Health TrialsbyHealthPanel

Primary vs Secondary Closure of Tracheo-cutaneous Fistulas

ConditionsTracheostomy ComplicationPost Tracheostomy ComplicationsTracheostomy
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversité de Sherbrooke

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Being covered by the RAMQ

Having a tracheostomy either percutaneous or surgical

Being ready for canula removal and closure of the fistula

Disqualifiers

Presenting a contraindication to primary tracheotomy closure (granuloma)

Unable to consent

Refusal to participate

Trial design

Design model

Parallel

Treatments tested in this trial

  • Primary closure of tracheo-cutaneous fistula

    Procedure/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 fistula

    Procedure/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.

Treatment groups

44 Participants
are divided into 2 treatment groups
Group A: Primary closure of tracheo-cutaneous fistulaOther 1 intervention
Group B: Secondary closure of tracheo-cutaneous fistulaOther 1 intervention

Trial outcomes

Primary outcomes

1

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

Secondary outcomes

1

Healing time

This outcome will evaluate time until full closure of the wound using both methods of closure.

Time frame
6 months
2

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
3

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
4

Persisting fistula

This outcome intends to evaluate the frequency of persisting fistula using either method of closure.

Time frame
6 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Université de Sherbrooke

Lead sponsor

Source ClinicalTrials.gov
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