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临床试验/NCT01918813
NCT01918813已完成不适用

Risk of Methicillin-resistant S.Aureus (MRSA) Infections in MRSA Carrier Under Introduction of Rapid MRSA Screening

Chikara Tashiro1 个研究点 分布在 1 个国家目标入组 662 人开始时间: 2009年11月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
662
试验地点
1
主要终点
The incidence of MRSA infections between patients with and without preoperative nasal MRSA colonization

研究概览

简要总结

This study was designed to evaluate the effect of a targeted preoperative Methicillin-resistant Staphylococcus aureus (MRSA) detection by polymerase chain reaction (PCR) on either endogenous or exogenous postoperative MRSA infections in a high risk population undergoing gastroenterological surgery. The primary endpoint was to investigate whether the potentially high incidence of MRSA infections in patients with MRSA nasal colonization before surgery can be prevented with a PCR-based strategy. The second endpoint was to investigate the impact of acquisition of MRSA colonization after surgery on the occurrence of MRSA infections. Investigators hypothesize that postoperative MRSA infection is prevented by a targeted screening strategy in preoperative MRSA carrier, and there is limited effect in patients with postoperative MRSA acquisition.

详细描述

Target screening for nasal carriage of MRSA by polymerase chain reaction (PCR) was performed before or on admission. In order to identify MRSA nasal acquisition while on the ward, all patients who were negative before surgery were re-screened every 7 days until discharge. The inclusion criteria for screening were patients undergoing inflammatory bowel disease surgery on ward A, and those undergoing major hepato-biliary-pancreatic surgery on ward B. Investigators classified enrolled patients into preoperative MRSA nasal carriage, postoperative nasal acquisition in patients who were negative for PCR assay before surgery, and non-nasal MRSA carriage during hospitalization. Development of postoperative infections caused by MRSA was assessed according to the nasal MRSA carriage status. MRSA infections rate was also compared between the 2-years of the intervention period and the previous 2-year control period on each ward.

Control measures in identified MRSA carriers consisted of contact precautions, antibiotic prophylaxis with a single dose of vancomycin 1g in addition to cephalosporins, and topical decolonization of MRSA (application of 2% mupirocin ointment twice daily to nares for 5 days and a bath with 4% chlorhexidine daily for 3-5 days). Although contact precautions were used when caring for MRSA-colonized patients, isolation/cohorting was not routinely practiced.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Prevention
盲法
None

入排标准

年龄范围
17 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • patients undergoing inflammatory bowel disease (IBD) surgery
  • patients undergoing major hepato-biliary-pancreatic surgery

排除标准

  • emergency surgery,
  • age less than 18 years old
  • known allergy to mupirocin or chlorhexidine.

研究组 & 干预措施

Preoperative MRSA nasal colonization

Experimental

Interventions in arm of preoperative MRSA nasal colonization consisted of antibiotic prophylaxis with a single dose of vancomycin 1g in addition to cephalosporins, and topical decolonization of MRSA with application of 2% mupirocin ointment twice daily to nares for 5 days

干预措施: vancomycin, mupirocin ointment (Drug)

结局指标

主要结局

The incidence of MRSA infections between patients with and without preoperative nasal MRSA colonization

时间窗: Intervention period 2 years

次要结局

  • The incidence of MRSA infections between intervention and control period.(Intervention period 2 years, control period 2 years)

研究者

发起方
Chikara Tashiro
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Chikara Tashiro

Director of hospital

Hyogo Medical University

研究点 (1)

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