RecruitingNAINTERVENTIONAL

Primary vs Secondary Closure of Tracheo-cutaneous Fistulas

This study is looking into the best way to close a small hole in the neck, called a tracheo-cutaneous fistula, which sometimes remains after a tracheostomy tube is removed. Researchers are comparing two common methods: 'primary closure' and 'secondary closure'. A tracheostomy is a procedure where a breathing tube is placed in the windpipe through a small opening in the neck. Once the tube is no longer needed, this opening needs to be closed. This study aims to find out if one closure method leads to better outcomes for patients, by comparing how people recover and feel after each approach. They will follow participants over a long period to understand the differences.

At a glance

Status

Recruiting

Phase

Sponsor

Université de Sherbrooke

Enrolment target

Start

12 Jan 2021

Estimated completion

01 Jul 2026

Tracheostomy Complication Post Tracheostomy Complications Tracheostomy

What is this study about?

When someone has had a tracheostomy, which is an opening made in the neck to help them breathe, the breathing tube eventually needs to be removed. After the tube is out, a small hole (doctors call this a tracheo-cutaneous fistula) is left in the neck. This hole then needs to be closed.

There are a couple of ways doctors can close this hole. The two main ways being looked at in this study are 'primary closure' and 'secondary closure'. Primary closure usually means stitching the hole closed right away. Secondary closure often involves letting the hole heal on its own gradually, or with less direct intervention. The purpose of this study is to compare these two methods side-by-side.

Researchers want to understand if one method of closing the hole is better than the other. They will be looking at things like how well the wound heals, if there are any problems, and how patients feel about their recovery. By comparing the outcomes, they hope to find the best way to help future patients who need their tracheostomy hole closed.

Key takeaways

The study compares two ways to close a tracheostomy hole.
It aims to find out which method (primary or secondary closure) works best.
Participation involves being randomly assigned one of the two closure methods.
Researchers will follow your recovery over time using questionnaires.
You must be 18 or older and ready for your tracheostomy tube to be removed.

Who may be eligible?

To join this study, you must be covered by a Canadian health insurance plan called RAMQ. You also need to have had a tracheostomy, whether it was put in place with surgery or using a different method.

Most importantly, you must be at a point where your doctors have decided that your tracheostomy tube can be safely removed, and the hole in your neck is ready to be closed. You should also be at least 18 years old; there's no upper age limit.

You won't be able to take part if you have a specific condition called a 'granuloma' around your tracheostomy site, as this might make primary closure unsuitable for you. Also, you need to be able to understand the study and agree to participate, and you must not refuse to take part.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you at least 18 years old?
Do you have RAMQ health coverage?
Have you had a tracheostomy (surgical or percutaneous)?
Has your doctor said you're ready to have your tracheostomy tube removed and the hole closed?
Do you not have a granuloma (a type of growth) around your tracheostomy site?

Answer every question to see your result.

What does participation involve?

If you decide to join this study, after your tracheostomy tube is removed, doctors will randomly decide which method will be used to close the hole in your neck – either primary or secondary closure. This means you won't get to choose which method you receive, as it will be decided by chance, like flipping a coin.

After the closure, the study team will follow up with you for a substantial period. They will use different questionnaires to check on your recovery and how you are feeling. The exact number of visits or the duration of follow-up isn't specified, but it will be long enough to properly compare the two closure methods. You won't be given any new medications specifically for the study.

Potential risks and benefits

Patients who take part in this study may benefit from closer monitoring of their healing and recovery than usual. It could also help doctors learn more about the best way to close tracheostomy holes, which would help many people in the future. As with any medical procedure, there are always some risks, but these are existing, standard treatments for closing the hole. You will always have the right to leave the study at any time, for any reason, without it affecting your medical care.

Locations (1)

Centre hospitalier universitaire de Sherbrooke
Verified postcode
Sherbrooke, Canada· Recruiting

Common questions

What is a tracheo-cutaneous fistula?

It's the small hole in your neck that remains after your breathing tube (tracheostomy tube) has been removed.

What does 'primary closure' mean?

It's one way doctors can close the hole in your neck, often by stitching it closed right away.

What does 'secondary closure' mean?

This is another way to close the hole. It might involve letting the hole heal on its own over time or with a less direct approach than primary closure.

Will I get to choose how my hole is closed?

No, if you join the study, the method will be chosen randomly by the researchers to ensure a fair comparison.

How long will I be followed in the study?

The study will follow you for a 'substantial period' after your hole is closed to properly compare the results of each method.

How to find out more

Simon Brisebois, MD, MSC

simon.brisebois@usherbrooke.ca 8193461110 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.