Primary vs Secondary Closure of Tracheo-cutaneous Fistulas (TRACH)

Université de Sherbrooke

Status: Enrolling

Conditions: Tracheostomy Complication; Post Tracheostomy Complications; Tracheostomy

Treatments: Procedure: Primary closure of tracheo-cutaneous fistula; Procedure: Secondary closure of tracheo-cutaneous fistula

Study type: Interventional

Funder types: Other

Identifiers

NCT04647968

2021-3699

Details and patient eligibility

About

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.

Full 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.

Enrollment: 44 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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44 participants in 2 patient groups

Primary closure of tracheo-cutaneous fistula

Other group

Description:

This group will undergo a protocoled primary closure of their tracheotomy.

Treatment:

Procedure: Primary closure of tracheo-cutaneous fistula

Secondary closure of tracheo-cutaneous fistula

Other group

Description:

This group will undergo a protocoled secondary closure of their tracheotomy.

Treatment:

Procedure: Secondary closure of tracheo-cutaneous fistula