MIR-CABG: A Randomized, Double-blind, Placebo-controlled, Single-Center Study to Evaluate the Impact of Mupirocin on Infection Rate Post Coronary Artery Bypass Grafting
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 974
- 试验地点
- 1
- 主要终点
- Surgical Site Infection
研究概览
简要总结
The hypothesis is that application of Mupirocin to the nose before and after coronary artery bypass grafting surgery will reduce the incidence of surgical site infections.
详细描述
Mupirocin applied to the nares is effective in eradicating nasal carriage of Staphylococcus species. Abundant evidence has documented that a majority of gram positive surgical site infections share bacterial phenotypes identical with nasal phage types. Conflicting literature exists regarding the efficacy of mupirocin in reducing the incidence of surgical site infections. A randomized prospective double-blind placebo-controlled trial is needed to help settle this question in the setting of coronary artery bypass grafting surgery where surgical site infections carry significant morbidity, cost, and mortality.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults >18 years old undergoing Coronary Artery Bypass Grafting Surgery (CABG) with or without concomitant cardiac valve surgery or other cardiac surgery,
- •Median sternotomy wound
- •Capable of informed consent
排除标准
- •Allergy to mupirocin or components
- •Pregnant or lactating females
- •Emergency surgery
- •Pre-existing ongoing infection
研究组 & 干预措施
Control
Placebo made from Glaxal base Applied once 1 day preoperatively and bid for 3 days postoperatively.
干预措施: Mupirocin (Drug)
Mupirocin
Mupirocin ointment applied to nares once 1 day preoperatively and bid for 3 days postoperatively.
干预措施: Mupirocin (Drug)
结局指标
主要结局
Surgical Site Infection
时间窗: <30 days post operation
Surgical site infections (SSI) are classified as superficial, deep, or organ surgical site infections based on CDC definition.
次要结局
- Mortality(< or = 30 days post operation)
- Serious adverse durg effects(< or = 30 day post operation)
- S. aureus carrier status(< or = 30 day post operation)
研究者
Dr Craig Brown
Director of Clinical Trials, New Brunswick Heart Centre
Horizon Health Network