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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine the better method for closing a tracheo-cutaneous fistula, a small hole left in the neck after removing a tracheostomy tube. Researchers are comparing primary closure, where the hole is closed immediately, with secondary closure, which allows it to heal on its own first. Individuals who have had a tracheostomy and are ready to have the tube removed might be suitable candidates for this trial. As an unphased trial, it offers participants the chance to contribute to medical knowledge and potentially enhance future care for others with similar conditions.

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 prior data suggests that these closure techniques for tracheo-cutaneous fistula are safe?

Research has shown that both primary and secondary methods for closing tracheo-cutaneous fistulas are generally safe. Studies confirm that primary closure is safe and effective, though careful monitoring of patients after surgery is important. Complications are rare, with major complications occurring in about 3.4% of cases and minor ones slightly higher at 4.5%.

For secondary closure, research indicates it is very effective, particularly for patients without airway blockages. This method is often preferred because it can help reduce complications. Overall, both methods are well-tolerated with low complication rates, making them promising options for treating tracheo-cutaneous fistulas. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores two different methods for closing a tracheo-cutaneous fistula, which is an opening in the neck after a tracheotomy. Unlike the usual approaches, which may vary widely in technique and timing, this trial focuses on standardizing the process with clear protocols for both primary and secondary closure methods. The goal is to determine which approach leads to better outcomes, such as quicker healing and fewer complications. By comparing these two specific closure techniques, researchers hope to offer more consistent and effective solutions for patients, ultimately improving their quality of life.

What evidence suggests that these closure techniques are effective for tracheo-cutaneous fistula?

This trial will compare two main methods for closing tracheo-cutaneous fistulas (TCF): primary closure and secondary closure. Research has shown that both methods are effective. In children, studies indicate these methods have similar success rates and acceptable levels of complications. Success with the primary closure method may decrease as the child ages. The secondary closure method, often considered the most effective, works best when combined with other techniques. Overall, both methods are safe and reliable for treating TCF. ^{2 3 4 5 6}

Who Is on the Research Team?

Simon Brisebois, MD, MSC

Principal Investigator

Université de Sherbrooke

Are You a Good Fit for This Trial?

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 for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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]

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]

Citations

1.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/18926208/

Primary closure of persistent tracheocutaneous fistula in ...

Conclusion: Partial excision and primary closure of persistent TCF is safe and effective. Drain placement and overnight observation are imperative. Careful ...

2.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S0165587616302579

Tracheocutaneous fistula closure in children

Both primary and secondary closure techniques for persistent tracheocutaneous fistulas in children are effective and associated with acceptable rates of ...

3.

journals.sagepub.com

journals.sagepub.com/doi/full/10.1177/01455613231179690

Comparison Between Flap and Primary Closures of ...

In primary closure, a significant decrease in the success rate with increasing age at the time of decannulation was observed. In addition, the ...

4.

jamanetwork.com

jamanetwork.com/journals/jamaotolaryngology/fullarticle/1814415

Comparison of 2 Techniques of Tracheocutaneous Fistula ...

Conclusions and Relevance The rates of success and complications were not significantly different between TCF closure and excision groups.

5.

clinicaltrials.gov

clinicaltrials.gov/study/NCT04647968

Primary vs Secondary Closure of Tracheo-cutaneous Fistulas

The mean of this study is to compare primary and secondary closure of tracheo-cutaneous fistulas and evaluate the differences in outcomes between both ...

6.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S0165587622003883

Outcomes and complications of simple layered closure ...

Surgical closure of the TCF is technically easy but post-operative complications can be immediate and life-threatening.