Zhang Caizhen, Mi Weiping, Zhu Yajun, Li Yonghao, Cao Yifan, Li Zhensu
Department of Thyroid Surgery, The First Hospital of Shanxi Medical University, Taiyuan, 0370001, People's Republic of China.
Department of General Surgery, Department of Hepato-Bilio-Pancreatic Surgery, Beijing Hospital, National Center of Gerontology, Institute of Geriatric Medicine, Chinese Academy of Medical Sciences, Beijing, 100730, People's Republic of China.
Ther Clin Risk Manag. 2024 Dec 9;20:837-847. doi: 10.2147/TCRM.S491307. eCollection 2024.
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).
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.
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.
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).
Patients were randomly assigned to the control and experimental groups, ensuring the fairness and reliability of the study.
The study was retrospectively registered with the China Clinical Trial Registry (ChiCTR2400087677) on August 1, 2024.
本研究纳入了2024年4月至7月期间在山西医科大学第一医院甲状腺外科住院的294例患者。患者被随机分为对照组（145例患者）和实验组（149例患者）。
对照组采用传统胶带固定引流管，而实验组采用新开发的固定贴片并结合独特的“C”形和“S”形固定方法。两组均采用垂直负压引流。
本研究的目的是评估一种新型手术引流固定贴片及方法在甲状腺手术中的临床效果和患者满意度。假设是新型固定贴片及方法将减少与引流管相关的不良事件，提高患者舒适度，并提高患者满意度。
与对照组相比，实验组与引流管相关的不良事件发生率显著更低，包括移位、感染和渗漏（3.40% 对53.10%，P<0.05）。此外，实验组患者的颈部/咽喉疼痛评分更低（平均评分：0.84对对照组的1.40，P<0.05），且未出现引流管牵拉痛（0% 对对照组的1.16%，P<0.05）。此外，实验组几乎无需更换贴片（0% 对对照组的70.86%，P<0.05）。实验组患者对固定方法的满意度显著更高（83.3% 对对照组的46.9%，P<0.05）。
患者被随机分配至对照组和实验组，确保了研究的公平性和可靠性。
该研究于2024年8月1日在中国临床试验注册中心（ChiCTR2400087677）进行了回顾性注册。
