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.

Tracheostomy is commonly performed in patients who require airway management after oral and maxillofacial head and neck tumor surgery. Stable fixation of the tracheostomy tube and appropriate wound care are important for maintaining airway safety, reducing local complications, and improving patient comfort. Conventional fixation methods, such as gauze ties or routine fixation straps, may become contaminated by blood or secretions, may cause friction or pressure on the cervical skin, and may require frequent replacement. These issues can increase nursing workload and may contribute to local skin injury, infection, tube displacement, or patient discomfort.

This randomized controlled trial was designed to evaluate the clinical application value and efficacy of a novel self-adhesive bidirectional tracheostomy tube fixation device. The device is intended to provide stable tracheostomy tube fixation while facilitating wound observation, dressing replacement, and daily nursing care.

Eligible patients were post-tracheostomy patients with oral cancer who were conscious, had adequate comprehension and communication ability, had intact cervical skin without infection or skin disease, and provided informed consent. Patients with pre-existing pressure injury, skin damage, allergy, or infection in the anterior cervical region before tracheostomy, pregnant women, minors, and patients with psychiatric disorders were excluded.

Participants were randomly assigned to two groups. The control group received routine tracheostomy care, including conventional tube fixation, nebulization therapy as prescribed, sputum suctioning as needed, regular inner cannula cleaning, and routine sterile gauze dressing care. The treatment group received routine tracheostomy care plus the novel self-adhesive bidirectional tracheostomy tube fixation device. The device was replaced once daily, or earlier if blood or exudate soaked two-thirds of the device.

The primary outcome was the occurrence of infection or inflammatory signs around the tracheostomy wound, including redness, swelling, heat, and pain. Secondary outcomes included the frequency of device or dressing replacement, duration of each wound care procedure, new cervical skin injury, tracheostomy tube displacement, and patient-reported neck comfort. Safety assessments included changes in oxygen saturation before and after use and the recording of adverse events, including tube dislodgement.

The purpose of this study was to determine whether the novel tracheostomy tube fixation device could improve nursing efficiency, reduce tracheostomy-related complications, and improve patient comfort compared with conventional fixation and routine tracheostomy care.

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.

De-identified individual participant data underlying the main study results will be shared after removal of personal identifiers. Shared data may include baseline characteristics, intervention records, outcome measures, and adverse event data. No names, hospital identification numbers, contact information, or other personally identifiable information will be shared.

Beginning November 1, 2026, and available for 5 years.

Data will be available to qualified researchers for academic and non-commercial research purposes after submission of a reasonable request and approval by the principal investigator and the study institution. Requesters will be required to sign a data use agreement and comply with ethical and privacy protection requirements.

This was an open-label study because the tracheostomy tube fixation method was visible to both participants and care providers. No masking was implemented.