超氧化溶液腹腔和伤口灌洗对穿孔性阑尾炎行开腹阑尾切除术术后手术部位感染的影响（PLaSSo）：随机临床试验。
Effect of peritoneal and wound lavage with super-oxidized solution on surgical-site infection after open appendicectomy in perforated appendicitis (PLaSSo): randomized clinical trial.
机构信息
Department of Surgery, Queen Elizabeth Hospital, Kota Kinabalu, Malaysia.
Department of Surgery, Queen Elizabeth II Hospital, Kota Kinabalu, Malaysia.
出版信息
BJS Open. 2024 Sep 3;8(5). doi: 10.1093/bjsopen/zrae121.
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.
背景
经开放性阑尾切除术治疗穿孔性阑尾炎后发生的手术部位感染会延长住院时间和治疗费用，同时降低患者的生活质量。缺乏评估超氧化溶液在穿孔性阑尾炎中的作用的随机临床试验 (RCT) 数据。本研究旨在确定经开放性阑尾切除术治疗穿孔性阑尾炎时，使用超氧化溶液进行腹腔和伤口冲洗是否可以降低手术部位感染的风险。
方法
本研究为 2020 年 9 月至 2022 年 3 月期间进行的多中心 RCT，纳入年龄 13 岁及以上、接受开放性阑尾切除术治疗穿孔性阑尾炎的患者，随机分为接受超氧化溶液或生理盐水进行腹腔和伤口冲洗的两组。主要结局为术后 30 天内的手术部位感染。随机化采用计算机生成，通过不透明、顺序编号、密封信封进行分配隐藏。治疗分配对患者、外科医生、结局评估者和进行分析的统计人员均设盲。
结果
共有 102 例连续患者（超氧化溶液组 51 例，生理盐水组 51 例）被随机分配并纳入意向治疗分析。超氧化溶液组的总手术部位感染显著减少（8 例[15.6%]比 19 例[37.2%]；相对风险 [RR] 0.42；95%置信区间 [CI] 0.20 至 0.87；P=0.014），且浅表手术部位感染也显著减少（5 例[9.8%]比 18 例[35.3%]；RR 0.28；95%CI 0.11 至 0.69；P=0.002），需要治疗的患者人数为 4 人。两组均无不良事件发生。
结论
与生理盐水相比，经开放性阑尾切除术治疗穿孔性阑尾炎时，使用超氧化溶液进行腹腔和伤口冲洗可降低手术部位感染的风险。
试验注册
ClinicalTrials.gov 标识符：NCT04512196。
Zotero 插件