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Completed NCT07701226

Novel Tracheostomy Tube Fixation Device in Oral Cancer Patients

Conditions: Tracheostomy, Oral Cancer, Post-Tracheostomy Care, Tracheostomy Complications

Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 150
Sponsor: Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine

Location: Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine Shanghai Shanghai Municipality

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.

Eligibility Criteria

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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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07701226). StuddyBuddy aggregates publicly available trial information.