Prevention of Nosocomial Infection in Cardiac Surgery by Decontamination of the Naso- and Oropharynx With Chlorhexidine. A Randomized, Double-Blind, Placebo-Controlled Clinical Trial.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 1,000
- 试验地点
- 2
- 主要终点
- Nosocomial Infection
研究概览
简要总结
Does chlorhexidine gluonate, a simple broad-spectrum antimicrobial agent with virtually no adverse-effects lower the incidence of NI after cardiac surgery, especially with respect to LTI and SSI?
详细描述
Nosocomial infections (NIs) after open heart surgery are recognized as an important cause of morbidity and mortality with a prolonged hospital stay, increased need for of antibiotics, decreased quality of life and higher concomitant costs. Decontamination of the oropharynx seems important, since there is direct evidence of an association between pulmonary infection and oral health. Another important strategy involves the eradication of Staphylococcus aureus, the most important pathogen causing SSI. The most common reservoir of S.aureus is the anterior nares and eradication can be achieved by the application of topical antibiotics. Although promising results have been reported for both strategies, they are not widely used as routine prevention methods because of the variability of trial design, the concern about the emergence of antimicrobial resistance and increased costs. Further research is essential to evaluate different protocols, antimicrobial agents and cost-effectiveness.
Fur this purpose, we designed a clinical trial to study wether a simple broad-spectrum antimicrobial agent with virtually no adverse-effects would lower the incidence of NI after cardiac surgery, especially with respect to LTI and SSI.
Comparison(s): Oropharyngeal and nasal decontamination with chlorhexidine compared to placebo in patients after cardiothoracic surgery
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •all adult patients (above 18) who were scheduled to undergo sternotomy for cardiothoracic surgery
排除标准
- •emergency procedures, a preoperative infection and/or the use of antibiotics, hypersensitivity to chlorhexidine gluconate (CHX), absence of written informed consent or presence of an alternative prophylactic regimen like selective decontamination of the digestive tract
结局指标
主要结局
Nosocomial Infection
次要结局
- Respiratory tract and surgical site infection; S. aureus nasal carriage, nonprophylactic antibiotic use, hospital stay, in-hospital mortality, optimal duration of preoperative trial medication and medication adverse-effects.
