Primary vs Secondary Closure for Tracheo-cutaneous Fistula

(TRACH Trial)

Overseen By Brigitte Routhier-Chevrier, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Université de Sherbrooke

Disqualifiers: Granuloma, unable to consent, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 1 day

44 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment for tracheo-cutaneous fistula closure?

Research shows that both primary and secondary closure methods for tracheo-cutaneous fistula (a persistent opening in the neck after a breathing tube is removed) are effective, with high success rates. However, primary closure may lead to more severe complications, while secondary closure is safer but might require additional surgery. ^{1 2 3 4 5}

Is tracheocutaneous fistula closure safe for humans?

Tracheocutaneous fistula closure, whether by primary closure or healing by secondary intention, is generally considered safe in humans, though primary closure may have more severe potential complications. Studies show that both methods are effective, but primary closure has been associated with life-threatening complications in some cases, while secondary intention healing is safer but may require additional surgery. ^{1 2 3 4 6}

How does the treatment for tracheo-cutaneous fistula differ from other treatments?

The treatment for tracheo-cutaneous fistula can involve either primary closure, which provides immediate resolution but has a higher risk of severe complications, or secondary closure, which minimizes complications but may require more time and potential revision surgery. This approach is unique because it balances immediate results with long-term safety, unlike other treatments that may not address these specific concerns. ^{1 3 4 5 7}

What is the purpose of 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.

Research Team

Simon Brisebois, MD, MSC

Principal Investigator

Université de Sherbrooke

Eligibility Criteria

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.

Inclusion Criteria

I am ready to have my fistula closed and the tube removed.

Being covered by the RAMQ

I have a tracheostomy.

Exclusion Criteria

I am unable to give consent by myself.

I do not wish to participate in the trial.

I cannot have my tracheotomy closed due to a granuloma.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo either primary or secondary closure of their tracheo-cutaneous fistula

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after closure, with assessments at 1 week, 1 month, 3 months, and 6 months

6 months

Multiple visits (in-person and virtual)

Treatment Details

Interventions

• Primary closure of tracheo-cutaneous fistula
• Secondary closure of tracheo-cutaneous fistula

Trial Overview 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.

Participant Groups

Group I: Secondary closure of tracheo-cutaneous fistula Experimental Treatment 1 Intervention

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

Group II: Primary closure of tracheo-cutaneous fistula Experimental Treatment 1 Intervention

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

Primary closure of tracheo-cutaneous fistula is already approved in United States, European Union for the following indications:

Approved in United States as Primary closure of tracheocutaneous fistula for:

• Closure of tracheocutaneous fistulas in pediatric and adult patients

Approved in European Union as Primary closure of tracheocutaneous fistula for:

• Closure of tracheocutaneous fistulas in pediatric and adult patients

Who Is Running the Clinical Trial?

Université de Sherbrooke

Lead Sponsor

Trials

317

Recruited

79,300+

Findings from Research

In a study of 216 pediatric patients with tracheocutaneous fistula (TCF), both primary closure and healing by secondary intention showed similar complication and revision rates, suggesting no significant advantage of one method over the other.

Despite the lack of statistical differences, the authors have shifted to using secondary intention as the standard practice for TCF closure to minimize potential severe complications associated with primary closure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tracheocutaneous fistula closure in the pediatric population: should secondary closure be the standard of care? Osborn, AJ., de Alarcón, A., Hart, CK., et al.[2022]

A systematic review of 27 studies involving 997 patients found that both primary and flap closures for tracheocutaneous fistulas (TCF) have high success rates (97.9% for primary and 98% for flap closures) and similar major complication rates, indicating both methods are effective surgical options.

The study also noted that older age at decannulation and longer time from decannulation to closure were associated with decreased success rates and increased major complications, suggesting that these factors should be considered when planning TCF repair.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison Between Flap and Primary Closures of Persistent Tracheocutaneous Fistula: A Scoping Review. Almutairi, N., Alshareef, W., Almakoshi, L., et al.[2023]

A systematic review of 14 studies involving 646 children with persistent tracheocutaneous fistula (TCF) found that both primary closure and secondary intention techniques have high success rates, with 95.7% and 92.7% respectively.

There were no significant differences in complication rates or treatment success between the two surgical techniques, indicating that both methods are safe and effective options for treating TCF in children.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Systematic review of surgery for persistent pediatric tracheocutaneous fistula. Lewis, S., Arjomandi, H., Rosenfeld, R.[2022]

In a study of 64 pediatric patients with tracheocutaneous fistulas (TCF) after tracheostomy, closure by secondary intention resulted in significantly shorter surgery duration and hospital stays compared to traditional primary closure.

Both closure methods showed similar safety profiles, with no significant differences in complications or the need for additional surgeries, indicating that secondary intention is an effective alternative for TCF closure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Primary versus secondary closure of tracheocutaneous fistula in pediatric patients. Azbell, CH., Bakeman, A., McCoy, JL., et al.[2022]

Primary closure of tracheocutaneous fistulas has been associated with significant complications, including pneumomediastinum, pneumothorax, and wound breakdown, leading to disappointing treatment outcomes.

The recommended alternative treatment involves excising the fistula tract down to the trachea and allowing it to heal by secondary intention, which may reduce complications and improve healing.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Management of tracheocutaneous fistula. Keenan, JP., Snyder, GG., Lehmann, WB., et al.[2019]

In a study of 98 children with persistent tracheocutaneous fistula (TCF), both primary closure and healing by secondary intention were found to be safe and effective surgical methods for repair.

The study indicated that the choice of surgical method and the duration of postoperative intubation did not significantly affect the outcomes, suggesting flexibility in treatment approaches for TCF in children.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Management of persistent tracheocutaneous fistula in the pediatric age group. Stern, Y., Cosenza, M., Walner, DL., et al.[2022]

A unique case report describes the successful closure of a persistent tracheocutaneous fistula (TCF) in a long-term ventilated patient using a local cartilo-musculo-cutaneous bilobed flap, highlighting an effective surgical option.

The case emphasizes the challenges of TCF closure and the potential for this specific flap technique to provide a solution where other methods may have failed, suggesting its efficacy in similar clinical situations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tracheocutaneous fistula closure using a Cartilo-musculo-cutaneous bilobed flap. Petersen, W., Amr, A., Held, M., et al.[2016]

References

1. England pubmed.ncbi.nlm.nih.gov

Tracheocutaneous fistula closure in the pediatric population: should secondary closure be the standard of care? [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Comparison Between Flap and Primary Closures of Persistent Tracheocutaneous Fistula: A Scoping Review. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

Systematic review of surgery for persistent pediatric tracheocutaneous fistula. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Primary versus secondary closure of tracheocutaneous fistula in pediatric patients. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Management of tracheocutaneous fistula. [2019]

6. United States pubmed.ncbi.nlm.nih.gov

Management of persistent tracheocutaneous fistula in the pediatric age group. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Tracheocutaneous fistula closure using a Cartilo-musculo-cutaneous bilobed flap. [2016]