用超氧化溶液进行腹膜和伤口灌洗对穿孔性阑尾炎开腹阑尾切除术(PLaSSo)后手术部位感染的影响:随机临床试验。

IF 3.5 3区 医学 Q1 SURGERY BJS Open Pub Date : 2024-09-03 DOI:10.1093/bjsopen/zrae121
Harivinthan Sellappan, Dinesh Alagoo, Christina Loo, Kaesarina Vijian, Rohamini Sibin, Jitt Aun Chuah
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引用次数: 0

摘要

背景:开腹阑尾切除术治疗穿孔性阑尾炎后的手术部位感染会增加住院时间和治疗费用,同时影响患者的生活质量。目前还缺乏随机临床试验(RCT)的数据来评估超氧化物歧化溶液在穿孔性阑尾炎中的作用。本研究旨在确定使用超氧化物溶液进行腹膜和伤口灌洗对降低阑尾炎穿孔开放性切除术后手术部位感染风险的效果:在 2020 年 9 月至 2022 年 3 月期间进行的这项多中心 RCT 中,年龄在 13 岁及以上、接受开腹阑尾切除术的穿孔性阑尾炎患者被随机分配接受超氧化物溶液或生理盐水进行腹膜和伤口灌洗。主要结果是术后30天内的手术部位感染。随机化由计算机生成,并通过不透明、按顺序编号、密封的信封进行分配隐藏。患者、外科医生、结果评估人员和进行分析的统计人员对所分配的治疗方案均为盲人:共有102名患者(超氧化物歧化溶液组51人,生理盐水组51人)被随机分配并纳入意向治疗分析。超氧化物溶液组显著降低了总体手术部位感染(8 例(15.6%)对 19 例(37.2%);相对风险 (RR) 0.42;95% c.i. 0.20 至 0.87;P = 0.014)和浅表手术部位感染(5 例(9.8%)对 18 例(35.3%);RR 0.28;95% c.i. 0.11 至 0.69;P = 0.002),需要治疗的患者人数为 4 人。两组患者均未出现不良反应:结论:在穿孔性阑尾炎开腹阑尾切除术后,用超氧化溶液进行腹腔和伤口灌洗在预防手术部位感染方面优于生理盐水:试验注册:ClinicalTrial.gov Identifier:试验注册:ClinicalTrial.gov Identifier:NCT04512196。
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Effect of peritoneal and wound lavage with super-oxidized solution on surgical-site infection after open appendicectomy in perforated appendicitis (PLaSSo): randomized clinical trial.

Background: Surgical-site infection following open appendicectomy for perforated appendicitis increases length of hospital stay and treatment costs while compromising patients' quality of life. Data from randomized clinical trials (RCTs) evaluating the role of super-oxidized solution in perforated appendicitis are lacking. The study objective was to determine the effect of peritoneal and wound lavage with super-oxidized solution in reducing risk of surgical-site infection following open appendicectomy for perforated appendicitis.

Methods: In this multicentre RCT conducted between September 2020 and March 2022, patients aged 13 years and older with perforated appendicitis undergoing open appendicectomy were randomly assigned to receive peritoneal and wound lavage with either super-oxidized solution or normal saline. The primary outcome was surgical-site infection within 30 days after surgery. Randomization was computer-generated, with allocation concealment by opaque, sequentially numbered, sealed envelope. The patients, surgeons, outcome assessors and statisticians performing the analysis were blinded to treatment assigned.

Results: A total of 102 consecutive patients (51 in the super-oxidized solution group and 51 in the normal saline group) were randomized and included in the intention-to-treat analysis. The super-oxidized solution group showed a significant reduction in overall surgical-site infection (8 (15.6%) versus 19 (37.2%); relative risk (RR) 0.42; 95% c.i. 0.20 to 0.87; P = 0.014), and superficial surgical-site infection (5 (9.8%) versus 18 (35.3%); RR 0.28; 95% c.i. 0.11 to 0.69; P = 0.002), with a number-needed-to-treat of four patients. There were no adverse events in either group.

Conclusions: Peritoneal and wound lavage with super-oxidized solution is superior to normal saline in preventing surgical-site infection after open appendicectomy for perforated appendicitis.

Trial registration: ClinicalTrial.gov Identifier: NCT04512196.

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BJS Open
BJS Open SURGERY-
CiteScore
6.00
自引率
3.20%
发文量
144
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