Abstract
PARTICIPANTS: This study enrolled 294 patients admitted to the Thyroid Surgery Department of the First Hospital of Shanxi Medical University between April and July 2024. Patients were randomly assigned to either the control group (145 patients) or the experimental group (149 patients). INTERVENTIONS: The control group received traditional adhesive tape fixation for drains, while the experimental group utilized a newly developed fixation patch combined with a unique "C" and "S" fixation method. Both groups employed vertical negative pressure drainage. SPECIFIC OBJECTIVES OR HYPOTHESES: The aim of this study was to assess the clinical effectiveness and patient satisfaction with a novel surgical drain fixation patch and method in the context of thyroid surgery. The hypothesis was that the novel fixation patch and method would reduce drain-related adverse events, improve patient comfort, and increase patient satisfaction. OUTCOMES: The experimental group exhibited significantly lower rates of drain-related adverse events, including displacement, infection, and leakage, compared to the control group (3.40% vs 53.10%, P < 0.05). Additionally, patients in the experimental group reported lower neck/throat pain scores (mean score: 0.84 vs 1.40 in the control group, P < 0.05) and experienced no drain pulling pain (0% vs 1.16% in the control group, P < 0.05). Furthermore, the need for patch replacements was virtually eliminated in the experimental group (0% vs 70.86% in the control group, P < 0.05). Patient satisfaction with the fixation method was significantly higher in the experimental group (83.3% vs 46.9% in the control group, P < 0.05). RANDOMIZATION: Patients were randomly assigned to the control and experimental groups, ensuring the fairness and reliability of the study. TRIAL REGISTRATION: The study was retrospectively registered with the China Clinical Trial Registry (ChiCTR2400087677) on August 1, 2024.