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Primary vs Secondary Closure for Tracheo-cutaneous Fistula (TRACH Trial)

N/A

Recruiting

Led By Simon Brisebois, MD, MSC

Research Sponsored by Université de Sherbrooke

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Having a tracheostomy either percutaneous or surgical

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 week, 1 month, 3 months, 6 months

Awards & highlights

TRACH Trial Summary

This trial is comparing two ways to close a hole in the windpipe. They want to know if one method is better than the other.

Who is the study for?

This trial is for individuals with a tracheostomy who are ready to have their cannula removed and the fistula closed. They must be covered by RAMQ (Régie de l'assurance maladie du Québec). People cannot join if they can't consent, refuse to participate, or have conditions like granuloma that contraindicate primary tracheotomy closure.Check my eligibility

What is being tested?

The study aims to compare two methods of closing tracheo-cutaneous fistulas after a tracheostomy: primary closure (closing it immediately) versus secondary closure (closing it later on). It will assess which technique has better outcomes.See study design

What are the potential side effects?

While specific side effects are not detailed here, surgical procedures may include risks such as infection at the site of surgery, bleeding, pain or discomfort at the wound site, and potential complications related to anesthesia.

TRACH Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have a tracheostomy.

TRACH Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 week, 1 month, 3 months, 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 week, 1 month, 3 months, 6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 week, 1 month, 3 months, 6 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Patient satisfaction in regards to the scar (change)

Secondary outcome measures

Healing time

Persisting fistula

Respiratory complications

+3 more

TRACH Trial Design

2Treatment groups

Experimental Treatment

Group I: Secondary closure of tracheo-cutaneous fistulaExperimental Treatment1 Intervention

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

Group II: Primary closure of tracheo-cutaneous fistulaExperimental Treatment1 Intervention

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

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Université de SherbrookeLead Sponsor

292 Previous Clinical Trials

69,397 Total Patients Enrolled

Simon Brisebois, MD, MSCPrincipal InvestigatorUniversité de Sherbrooke

Media Library

Primary closure of tracheo-cutaneous fistula Clinical Trial Eligibility Overview. Trial Name: NCT04647968 — N/A

Tracheostomy Complications Research Study Groups: Primary closure of tracheo-cutaneous fistula, Secondary closure of tracheo-cutaneous fistula

Tracheostomy Complications Clinical Trial 2023: Primary closure of tracheo-cutaneous fistula Highlights & Side Effects. Trial Name: NCT04647968 — N/A

Primary closure of tracheo-cutaneous fistula 2023 Treatment Timeline for Medical Study. Trial Name: NCT04647968 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the current enrollment size for this clinical trial?

"Indeed, clinicaltrials.gov corroborates the fact that this medical research project is actively recruiting participants. It was first released on December 1st 2021 and last revised November 1st 2022; 44 individuals are needed from a single site."

Answered by AI

Can individuals apply to participate in this scientific experiment at the present moment?

"The data on clinicaltrials.gov indicates that this trial is still actively seeking participants and has been since January 12th 2021, with the most recent update being November 1st 2022."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Primary vs Secondary Closure of Tracheo-cutaneous Fistulas

Simon Brisebois 2021. "Primary vs Secondary Closure of Tracheo-cutaneous Fistulas". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04647968.