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预防手术部位感染:一项关于鼻用莫匹罗星软膏和鼻用聚维酮碘溶液的随机、开放标签试验。

Preventing surgical site infections: a randomized, open-label trial of nasal mupirocin ointment and nasal povidone-iodine solution.

作者信息

Phillips Michael, Rosenberg Andrew, Shopsin Bo, Cuff Germaine, Skeete Faith, Foti Alycia, Kraemer Kandy, Inglima Kenneth, Press Robert, Bosco Joseph

机构信息

New York University Hospital Center, New York, New York.

出版信息

Infect Control Hosp Epidemiol. 2014 Jul;35(7):826-32. doi: 10.1086/676872. Epub 2014 May 21.

Abstract

BACKGROUND

Treatment of Staphylococcus aureus colonization before surgery reduces risk of surgical site infection (SSI). The regimen of nasal mupirocin ointment and topical chlorhexidine gluconate is effective, but cost and patient compliance may be a barrier. Nasal povidone-iodine solution may provide an alternative to mupirocin.

METHODS

We conducted an investigator-initiated, open-label, randomized trial comparing SSI after arthroplasty or spine fusion in patients receiving topical chlorhexidine wipes in combination with either twice daily application of nasal mupirocin ointment during the 5 days before surgery or 2 applications of povidone-iodine solution into each nostril within 2 hours of surgical incision. The primary study end point was deep SSI within the 3 months after surgery.

RESULTS

In the modified intent-to-treat analysis, a deep SSI developed after 14 of 855 surgical procedures in the mupirocin group and 6 of 842 surgical procedures in the povidone-iodine group (P = .1); S. aureus deep SSI developed after 5 surgical procedures in the mupirocin group and 1 surgical procedure in the povidone-iodine group (P = .2). In the per protocol analysis, S. aureus deep SSI developed in 5 of 763 surgical procedures in the mupirocin group and 0 of 776 surgical procedures in the povidone-iodine group (P = .03).

CONCLUSIONS

Nasal povidone-iodine may be considered as an alternative to mupirocin in a multifaceted approach to reduce SSI.

TRIAL REGISTRATION

ClinicalTrials.gov identifier: NCT01313182.

摘要

背景

术前治疗金黄色葡萄球菌定植可降低手术部位感染(SSI)的风险。鼻用莫匹罗星软膏和外用葡萄糖酸氯己定的方案是有效的,但成本和患者依从性可能是一个障碍。鼻用聚维酮碘溶液可能是莫匹罗星的一种替代方案。

方法

我们开展了一项由研究者发起的、开放标签的随机试验,比较接受外用氯己定擦剂的患者在关节成形术或脊柱融合术后,于术前5天每天两次应用鼻用莫匹罗星软膏或在手术切口前2小时向每个鼻孔内滴注2次聚维酮碘溶液后的SSI情况。主要研究终点是术后3个月内的深部SSI。

结果

在改良意向性分析中,莫匹罗星组855例手术中有14例发生深部SSI,聚维酮碘组842例手术中有6例发生深部SSI(P = 0.1);莫匹罗星组5例手术发生金黄色葡萄球菌深部SSI,聚维酮碘组1例手术发生金黄色葡萄球菌深部SSI(P = 0.2)。在符合方案分析中,莫匹罗星组763例手术中有5例发生金黄色葡萄球菌深部SSI,聚维酮碘组776例手术中无1例发生金黄色葡萄球菌深部SSI(P = .03)。

结论

在降低SSI的多方面措施中,鼻用聚维酮碘可被视为莫匹罗星的替代方案。

试验注册

ClinicalTrials.gov标识符:NCT01313182。

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