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New tracheostomy tube holder aims to cut infections and boost comfort

NCT ID NCT07701226

Symptom relief Sponsor: Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 14, 2026 · Last updated Jul 15, 2026 · Updated 1 time

Summary

This trial tests a new self-adhesive device for securing tracheostomy tubes in oral cancer patients. The device is designed to protect the skin, reduce wound infections, and make dressing changes quicker and less frequent. Researchers compare it to standard fixation methods in 150 patients to see if it improves safety, nursing efficiency, and patient comfort.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
a novel self-adhesive bidirectional tracheostomy tube fixation device
What this could lead to
If effective, this device could reduce wound infections, skin damage, and discomfort for patients who need a tracheostomy tube, while also making care faster and easier for nurses.
What could go wrong
This is a single-center trial with 150 participants, so results may not apply to all patients. The device may not significantly improve outcomes compared to standard care.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

150 people

The number who actually took part.

Started

May 2025

Finished

Oct 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Patients aged 18 years or older. * Patients with oral cancer who underwent tracheostomy or required a tracheostomy tube during hospitalization. * Patients who were conscious and had normal comprehension and communication ability. * Patients with intact cervical skin without skin damage, skin disease, or infection. * Patients who voluntarily agreed to participate and provided written informed consent. Exclusion Criteria: * Patients with pre-existing pressure injury, skin damage, allergy, or infection in the anterior cervical region before tracheostomy. * Pregnant women. * Minors under 18 years of age. * Patients with psychiatric disorders. * Patients who were unable to cooperate with the study procedures or outcome assessments as judged by the investigators.

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Conditions

The condition(s) this trial relates to.

lip and oral cavity carcinoma Mouth Neoplasms

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Oral cancer Post-tracheostomy care Tracheostomy Tracheostomy complications

Contacts and locations

Locations

  • Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine

    Shanghai, Shanghai Municipality, 200011, China

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