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葡萄糖酸奥来尼定与聚维酮碘用于胃肠道手术后手术部位感染的随机对照试验

Randomized controlled trial of olanexidine gluconate and povidone iodine for surgical site infection after gastrointestinal surgery.

作者信息

Iida Hiroya, Maehira Hiromitsu, Kaida Sachiko, Takebayashi Katsushi, Miyake Toru, Tani Masaji

机构信息

Department of Surgery Shiga University of Medical Science Otsu Japan.

出版信息

Ann Gastroenterol Surg. 2023 Sep 9;8(2):332-341. doi: 10.1002/ags3.12739. eCollection 2024 Mar.

DOI:10.1002/ags3.12739
PMID:38455490
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC10914690/
Abstract

AIM

Antiseptics used at surgical sites are vital to preventing surgical site infections (SSI). In this study, a comparative investigation of the novel antiseptics olanexidine gluconate (OG) and povidone-iodine (PI) was conducted to determine whether OG is more effective than PI against SSI after gastrointestinal surgery.

METHODS

This prospective, randomized, single-blind, interventional, single-center study was conducted between August 2018 and February 2021. Patients scheduled for large-scale gastrointestinal surgeries were randomized into two groups and administered OG (OG group) or PI (PI group) as preoperative antiseptics. The primary endpoint was the SSI occurrence rate within 30 days after surgery.

RESULTS

In total, 525 patients were enrolled in this study, of whom 256 and 254 were in the OG and PI groups, respectively. The total SSI occurrence rate in the OG group (10.8%;  = 26) and the PI group (13.0%;  = 33) was not significantly different ( = 0.335). The occurrence rate of superficial incisional SSI and organ/space SSI did not significantly differ between the groups; however, that of deep incisional SSI showed a significant difference, with 0.4% ( = 1) in the OG group and 4.3% ( = 11) in the PI group ( = 0.003).

CONCLUSION

OG, as a preoperative skin antiseptic, did not reduce the occurrence rate of total SSI. However, deep incisional SSI may be reduced using OG.

摘要

目的

手术部位使用的防腐剂对于预防手术部位感染(SSI)至关重要。在本研究中,对新型防腐剂葡萄糖酸奥来尼定(OG)和聚维酮碘(PI)进行了比较研究,以确定OG在胃肠道手术后预防SSI方面是否比PI更有效。

方法

本前瞻性、随机、单盲、干预性、单中心研究于2018年8月至2021年2月进行。计划进行大型胃肠道手术的患者被随机分为两组,分别给予OG(OG组)或PI(PI组)作为术前防腐剂。主要终点是术后30天内的SSI发生率。

结果

本研究共纳入525例患者,其中OG组256例,PI组254例。OG组的总SSI发生率(10.8%;=26)和PI组(13.0%;=33)无显著差异(=0.335)。两组间浅表切口SSI和器官/腔隙SSI的发生率无显著差异;然而,深部切口SSI的发生率有显著差异,OG组为0.4%(=1),PI组为4.3%(=11)(=0.003)。

结论

OG作为术前皮肤防腐剂,并未降低总SSI的发生率。然而,使用OG可能会降低深部切口SSI的发生率。

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