{"title":"一种新型外科医用引流管防移位固定贴片及固定方法在甲状腺术后护理中的效果评价：一项随机试验。","authors":"Caizhen Zhang, Weiping Mi, Yajun Zhu, Yonghao Li, Yifan Cao, Zhensu Li","doi":"10.2147/TCRM.S491307","DOIUrl":null,"url":null,"abstract":"<p><strong>Participants: </strong>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).</p><p><strong>Interventions: </strong>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.</p><p><strong>Specific objectives or hypotheses: </strong>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.</p><p><strong>Outcomes: </strong>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).</p><p><strong>Randomization: </strong>Patients were randomly assigned to the control and experimental groups, ensuring the fairness and reliability of the study.</p><p><strong>Trial registration: </strong>The study was retrospectively registered with the China Clinical Trial Registry (ChiCTR2400087677) on August 1, 2024.</p>","PeriodicalId":22977,"journal":{"name":"Therapeutics and Clinical Risk Management","volume":"20 ","pages":"837-847"},"PeriodicalIF":2.8000,"publicationDate":"2024-12-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11640031/pdf/","citationCount":"0","resultStr":"{\"title\":\"Evaluation of the Effect of a New Surgical Medical Drain Anti-Dislodgement Fixation Patch and Fixation Method in Postoperative Thyroid Care: A Randomized Trial.\",\"authors\":\"Caizhen Zhang, Weiping Mi, Yajun Zhu, Yonghao Li, Yifan Cao, Zhensu Li\",\"doi\":\"10.2147/TCRM.S491307\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Participants: </strong>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).</p><p><strong>Interventions: </strong>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.</p><p><strong>Specific objectives or hypotheses: </strong>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.</p><p><strong>Outcomes: </strong>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). 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引用次数: 0
摘要
研究对象：本研究纳入了2024年4月至7月山西医科大学第一医院甲状腺外科收治的294例患者。患者被随机分配到对照组（145例）或实验组（149例）。干预措施：对照组采用传统的胶带固定引流管，实验组采用新开发的固定贴片结合独特的“C”、“S”固定方法。两组均采用垂直负压引流。具体目的或假设：本研究的目的是评估一种新型手术引流固定贴片和方法在甲状腺手术中的临床效果和患者满意度。我们的假设是，新的固定贴片和方法将减少引流相关的不良事件，提高患者的舒适度，提高患者的满意度。结果：实验组引流管相关不良事件发生率明显低于对照组（3.40% vs 53.10%, P < 0.05），包括移位、感染和渗漏。此外，实验组患者的颈部/咽喉疼痛评分较低（平均评分：0.84比对照组的1.40,P < 0.05），无引流管拔痛（0%比对照组的1.16%,P < 0.05）。此外，实验组几乎不需要更换补片（0% vs对照组70.86%,P < 0.05）。实验组患者对固定方法的满意度明显高于对照组（83.3% vs 46.9%, P < 0.05）。随机化：将患者随机分为对照组和实验组，确保研究的公平性和可靠性。试验注册：该研究于2024年8月1日在中国临床试验注册中心（ChiCTR2400087677）回顾性注册。
Evaluation of the Effect of a New Surgical Medical Drain Anti-Dislodgement Fixation Patch and Fixation Method in Postoperative Thyroid Care: A Randomized Trial.
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.
期刊介绍：
Therapeutics and Clinical Risk Management is an international, peer-reviewed journal of clinical therapeutics and risk management, focusing on concise rapid reporting of clinical studies in all therapeutic areas, outcomes, safety, and programs for the effective, safe, and sustained use of medicines, therapeutic and surgical interventions in all clinical areas.
The journal welcomes submissions covering original research, clinical and epidemiological studies, reviews, guidelines, expert opinion and commentary. The journal will consider case reports but only if they make a valuable and original contribution to the literature.
As of 18th March 2019, Therapeutics and Clinical Risk Management will no longer consider meta-analyses for publication.
The journal does not accept study protocols, animal-based or cell line-based studies.
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