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英文原标题： Impact of wound edge protection devices on surgical site infection after laparotomy: multicentre randomised controlled trial (ROSSINI Trial).作者：Thomas D Pinkney ,Melanie Calvert ,David C Bartlett ,Adrian Gheorghe ,Val Redman ,George Dowswell
期刊名称：BMJ
发表时间：2013-08-02
索引：BMJ.2013 8 2;:f4305.
中文摘要来源：张旭翻译 张麟审核
中文摘要
目的：研究创口边缘保护材料对减少开腹手术后手术部位感染的临床效果。
设计：多中心观察者盲法随机对照试验。
受试者：英国21家医院进行开腹手术的患者。
干预：标准护理或术中使用创口边缘保护材料。
主要结果指标：术后30日内发生手术部位感染，通过术后7日和30日经盲法的临床医生和期间患者自我报告进行评估。次要结果包括生活质量、住院时长、患者及手术特点对材料有效程度的影响。
结果：本研究共招募760例患者，其中382例分至材料组，378例分至对照组。材料组6例和对照组5例患者未进行开腹手术。每组各7例，共14例患者未能完成随访。共184例患者在术后30日内发生了手术部位感染，其中材料组91/369 (24.7%)，对照组93/366 (25.4%)（比值比0.97,95%置信区间0.69 to 1.36; P=0.85）。因此，未发现创口边缘保护材料有明显效果，这与临床医生的评估、患者自身的报告以及所有次要结果一致。在二级分析中，所有亚组均未发现使用该材料有显著临床收益的证据。
结论：创口边缘保护材料不能降低开腹手术患者的手术部位感染的发生率，因此不推荐常规使用该材料。
英文摘要
OBJECTIVE
To determine the clinical effectiveness of wound edge protection devices in reducing surgical site infection after abdominal surgery.
DESIGN
Multicentre observer blinded randomised controlled trial.
PARTICIPANTS
Patients undergoing laparotomy at 21 UK hospitals.
INTERVENTIONS
Standard care or the use of a wound edge protection device during surgery.
MAIN OUTCOME MEASURES
Surgical site infection within 30 days of surgery, assessed by blinded clinicians at seven and 30 days and by patient's self report for the intervening period. Secondary outcomes included quality of life, duration of stay in hospital, and the effect of characteristics of the patient and operation on the efficacy of the device.
RESULTS
760 patients were enrolled with 382 patients assigned to the device group and 378 to the control group. Six patients in the device group and five in the control group did not undergo laparotomy. Fourteen patients, seven in each group, were lost to follow-up. A total of 184 patients experienced surgical site infection within 30 days of surgery, 91/369 (24.7%) in the device group and 93/366 (25.4%) in the control group (odds ratio 0.97, 95% confidence interval 0.69 to 1.36; P=0.85). This lack of benefit was consistent across wound assessments performed by clinicians and those reported by patients and across all secondary outcomes. In the secondary analyses no subgroup could be identified in which there was evidence of clinical benefit associated with use of the device.
CONCLUSIONS
Wound edge protection devices do not reduce the rate of surgical site infection in patients undergoing laparotomy, and therefore their routine use for this role cannot be recommended.
TRIAL REGISTRATION
Current Controlled Trials ISRCTN 40402832.
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发表于 2013-9-27 11:29
发表于 2013-9-27 11:45
