Primary vs Secondary Closure of Tracheo-cutaneous Fistulas

NCT04647968 | Recruiting

• 1 other identifier: 2021-3699
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Tracheostomy Complication; Post Tracheostomy Complications; Tracheostomy

Keywords

tracheostomy; tracheostomy closure; tracheocutaneous fistula

Outcome Measures

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.

  1 week, 1 month, 3 months, 6 months

Secondary Outcomes (6)

• Healing time

  6 months

• Respiratory complications

  6 months

• Self reported quality of life related to dysphonia (change)

  1 week, 1 month, 3 months, 6 months

• Persisting fistula

  6 months

• Self reported quality of life related to dysphagia (change)

  1 week, 1 month, 3 months, 6 months

Study Arms (2)

Primary closure of tracheo-cutaneous fistula

OTHER

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

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.

Procedure: Secondary closure of tracheo-cutaneous fistula

Interventions

Primary closure of tracheo-cutaneous fistula PROCEDURE

This procedure will follow protocoled steps. It consists of a sutured closure of the tracheotomy following local anesthesia, done at bedside.

Primary closure of tracheo-cutaneous fistula

Secondary closure of tracheo-cutaneous fistula PROCEDURE

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.

Secondary closure of tracheo-cutaneous fistula

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Being covered by the RAMQ
• Having a tracheostomy either percutaneous or surgical
• Being ready for canula removal and closure of the fistula

You may not qualify if:

• Presenting a contraindication to primary tracheotomy closure (granuloma)
• Unable to consent
• Refusal to participate

Sponsors & Collaborators

• Université de Sherbrooke: lead

Study Sites (1)

Centre hospitalier universitaire de Sherbrooke

Sherbrooke, Quebec, J1G 2E8, Canada

RECRUITING

Study Officials

• Simon Brisebois, MD, MSC

  Université de Sherbrooke

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Simon Brisebois, MD, MSC

CONTACT

8193461110; simon.brisebois@usherbrooke.ca

Brigitte Routhier-Chevrier, MD

CONTACT

8193461110; brigitte.routhier-chevrier@usherbrooke.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: No masking because it is a surgical procedure
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor - Division of Otolaryngology - Head & Neck Surgery

Model Details: Randomized Controlled Trial

Study Record Dates

• First Submitted: November 12, 2020
• First Posted: December 1, 2020
• Study Start: January 12, 2021
• Primary Completion: January 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: July 23, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)