洗必泰皮肤消毒常被推荐用于大多数外科手术；然而，目前尚不清楚这些建议是否适用于先前首选聚维酮碘的创伤性污染伤口的手术。我们的目的是比较10%聚维酮碘水溶液和4%葡萄糖酸洗必泰水溶液对需要手术治疗开放性骨折患者手术部位感染风险的影响。

研究共纳入1683例患者，中聚维酮碘组828人，洗必泰葡萄糖酸盐组810人(平均年龄44·9岁[SD 18·0];女性629人(38%)，男性1009人(62%)。在已知主要结局的1571名参与者中，聚维酮碘组787名参与者中59人(7%)发生了手术部位感染，而葡萄糖酸洗必泰组784名参与者中58人(7%)发生了手术部位感染(优势比1.11,95% CI 0.74 ~ 1.65;p = 0·61;风险差0·6%，95% CI -1·4到3·4)。

对于需要手术固定开放性骨折的患者，可根据溶液可用性、患者禁忌症或产品成本，选择10%聚维酮碘水溶液或4%葡萄糖酸洗必泰水溶液进行皮肤消毒。这些发现可能对其他创伤的防腐也有意义。

Abstract

Background: Chlorhexidine skin antisepsis is frequently recommended for most surgical procedures; however, it is unclear if these recommendations should apply to surgery involving traumatic contaminated wounds where povidone-iodine has previously been preferred. We aimed to compare the effect of aqueous 10% povidone-iodine versus aqueous 4% chlorhexidine gluconate on the risk of surgical site infection in patients who required surgery for an open fracture.

Methods: We conducted a multiple-period, cluster-randomised, crossover trial (Aqueous-PREP) at 14 hospitals in Canada, Spain, and the USA. Eligible patients were adults aged 18 years or older with an open extremity fracture treated with a surgical fixation implant. For inclusion, the open fracture required formal surgical debridement within 72 h of the injury. Participating sites were randomly assigned (1:1) to use either aqueous 10% povidone-iodine or aqueous 4% chlorhexidine gluconate immediately before surgical incision; sites then alternated between the study interventions every 2 months. Participants, health-care providers, and study personnel were aware of the treatment assignment due to the colour of the solutions. The outcome adjudicators and data analysts were masked to treatment allocation. The primary outcome was surgical site infection, guided by the 2017 US Centers for Disease Control and Prevention National Healthcare Safety Network reporting criteria, which included superficial incisional infection within 30 days or deep incisional or organ space infection within 90 days of surgery. The primary analyses followed the intention-to-treat principle and included all participants in the groups to which they were randomly assigned. This study is registered with ClinicalTrials.gov, NCT03385304.

Findings: Between April 8, 2018, and June 8, 2021, 3619 patients were assessed for eligibility and 1683 were enrolled and randomly assigned to povidone-iodine (n=847) or chlorhexidine gluconate (n=836). The trial's adjudication committee determined that 45 participants were ineligible, leaving 1638 participants in the primary analysis, with 828 in the povidone-iodine group and 810 in the chlorhexidine gluconate group (mean age 44·9 years [SD 18·0]; 629 [38%] were female and 1009 [62%] were male). Among 1571 participants in whom the primary outcome was known, a surgical site infection occurred in 59 (7%) of 787 participants in the povidone-iodine group and 58 (7%) of 784 in the chlorhexidine gluconate group (odds ratio 1·11, 95% CI 0·74 to 1·65; p=0·61; risk difference 0·6%, 95% CI -1·4 to 3·4).

Interpretation: For patients who require surgical fixation of an open fracture, either aqueous 10% povidone-iodine or aqueous 4% chlorhexidine gluconate can be selected for skin antisepsis on the basis of solution availability, patient contraindications, or product cost. These findings might also have implications for antisepsis of other traumatic wounds.

Funding: US Department of Defense, Canadian Institutes of Health Research, McMaster University Surgical Associates, PSI Foundation.

文章连接：

www.thelancet.com/journals/lancet/article/PIIS0140-6736(22)01652-X/fulltext

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