Novel Tracheostomy Tube Fixation Device in Oral Cancer Patients (NCT07701226) | Clinical Trial Compass
CompletedNot Applicable
Novel Tracheostomy Tube Fixation Device in Oral Cancer Patients
China150 participantsStarted 2025-05-07
Plain-language summary
This study evaluated a novel tracheostomy tube fixation device in post-tracheostomy patients with oral cancer. After tracheostomy, conventional fixation methods may be associated with skin pressure injury, wound contamination, frequent dressing changes, tube displacement, and patient discomfort. The novel fixation device was designed to provide stable tube fixation, protect the cervical skin, facilitate wound care, and improve patient comfort.
A total of 150 eligible patients who underwent tracheostomy were randomly assigned to a treatment group or a control group. Patients in the control group received routine tracheostomy care and conventional fixation. Patients in the treatment group received the novel self-adhesive bidirectional tracheostomy tube fixation device in addition to routine tracheostomy care.
The study assessed whether the novel fixation device could reduce tracheostomy-related complications, improve nursing efficiency, reduce the frequency and duration of wound care, improve neck comfort, and maintain safe tracheostomy tube fixation.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Incidence of Tracheostomy Wound Infection
Timeframe: From intervention initiation to hospital discharge, up to 14 days
Trial details
NCT IDNCT07701226
SponsorShanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine