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临床试验/NCT00711685
NCT00711685已完成不适用

Topical Vancomycin in Prevention of Methicillin-Resistant Staphylococcal Related Mediastinitis in Patients Receiving Coronary Artery Bypass Graft

Far Eastern Memorial Hospital1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2007年1月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
50
试验地点
1

研究概览

简要总结

Sternal or mediastinal infections after heart operation occurs infrequently but carries a high cost in money, morbidity, and mortality. At our hospital, Staphylococcus species cause most of these infections and is uniformly sensitive to vancomycin. However, the relative low concentration of vancomycin in sternal bone was noted given intravenously. Topical vancomycin was therefore considered to apply on the cut edege of sternal bone before closure in patients receiving coronary artery bypass graft to evaluate the effect on reducing the infection rate of staphylococcus related mediastinitis (6). In addition, we try to observe that prophylactic use of topical vancomycin will increase the risk for acquiring resistant pathogen such as VISA (vancomycin-intermediate S. aureus), VRSA (Vancomycin-resistant S. aureus), VRE (vancomycin-resistant enterococcus)

详细描述

Background Postoperative sterno-mediastinitis is a life-threatening complication. Although the incidence rate is about 0.75 to 1.4% in all open heart operations, the association with morbidity, mortality and cost is unacceptably high (1, 2). Some risk factors should be minimized as possible, such as preoperative days in the hospital, and poor controlled blood sugar and other chronic underlying conditions. In addition, patients should shower the night and morning before surgery with chlorhexadine and remove hair with clipper or depilatory crème instead of a shave. These basic rules of sterile technique can't be emphasized enough and may reduce the occurrence of postoperative sterno-mediastinitis form 7.5 to 0.8% (3, 4).

The matter of prophylactic antibiotics is controversial. Although everybody agrees the necessity of using prophylactic antibiotics but which to use and how long it should be administered remain a debate. The most commonly occurring bacterial offenders in the institution always should be considered in selecting of prophylactic antibiotics.

Staphylococcus spp. is most common pathogens in most institutions and also in our hospitals. It is currently recommended that the use of vancomycin for perioperative prophylaxis should be considered only in patients with a life-threatening allergy toβ-lactam antibiotics or at institutions with a high rate of infections caused by MRSA or methicillin-resistant S. epidermidis (5). However, the relative low concentration of vancomycin in sternal bone was noted when given intravenously (5). According to the study performed by Vander et al. in 1989, we also try to apply vancomycin over the cut sternal edges in patients receiving CABG (coronary artery bypassing graft) and to evaluate the effect on reducing the infection of staphylococcus related mediastinitis (6). In addition, we try to observe that prophylactic use of topical vancomycin will increase the risk for acquiring resistant pathogen such as VISA (vancomycin-intermediate S. aureus), VRSA (Vancomycin-resistant S. aureus), VRE (vancomycin-resistant enterococcus).

Aim We try to apply vancomycin over the cut sternal edges in patients receiving CABG (coronary artery bypassing graft) and to evaluate the effect on reducing the infection of staphylococcus related mediastinitis. In addition, we try to observe the use of topical vancomycin will induce the collateral effect on increasing the infections of resistant pathogen such as VISA (vancomycin-intermediate S. aureus), VRSA (Vancomycin-resistant S. aureus), VRE (vancomycin-resistant enterococcus) or other infections caused by GNB or yeast.

Materials and methods

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

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

入选标准

  • Patients with coronary artery disease underwent aoronary artery bypass grafting

排除标准

  • Patients who ever received vancomycin or teicoplanin or linezolids within one week will be excluded. Other exclusion criteria are patients in pregnant, allergic to vancomycin, and hesitate to this study plan.

研究者

申办方类型
Other

研究点 (1)

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