Prevention of Infections in Cardiac Surgery: a Cluster-randomized Factorial Cross-over Trial
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 5,989
- 试验地点
- 4
- 主要终点
- Proportion of patients receiving antibiotics according to study protocol
研究概览
简要总结
There is clinical equipoise about the question of whether antibiotic prophylaxis should be given for a short period or an extended period of time as reflected by inconsistencies in major guidelines, current practices at Canadian centers, and as concluded in the three systematic reviews. There also is clinical equipoise on whether the addition of vancomycin to routine cefazolin prophylaxis can further reduce s-SSI rates. A short duration of combined antimicrobial prophylaxis can reduce side effects of exposure to antimicrobials such as infections with C. difficile or emergence of resistance, but may also reduce the incidence of s-SSIs. The objective of the eventual full scale study is to determine whether adding vancomycin to cefazolin can reduce SSIs as well as whether short-term prophylaxis is as effective as long-term prophylaxis. The rationale to conduct the proposed pilot study is to assess the feasibility to conduct this factorial cluster randomized cross-over trial, the adherence to the study protocol at each pilot site, the length of time to fill out the case report forms, and to get reliable estimates of event rates for sample size calculation for the main study
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
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 (≥18 years of age) undergoing open-heart surgery (sternotomy, including minimally-invasive surgical techniques).
排除标准
- •Patients on antibiotics at the time of surgery.
- •Previous enrollment in this trial.
- •Known MRSA carriers. Beta-lactam allergy (IgE-mediated) precluding the use of cefazolin
- •Participant in another study that may interfere with this trial.
研究组 & 干预措施
Cefazolin monotherapy, short course
One pre-op dose of cefazolin 30-60 minutes prior to surgery followed by a second dose either four hours after the first dose or upon wound closure (whatever comes first) will be administered
干预措施: Cefazolin (Drug)
Cefazolin monotherapy, long course
One pre-op dose of cefazolin 30-60 minutes prior to surgery followed by a second dose either four hours after the first dose or upon wound closure (whatever comes first) will be administered followed by additional five doses every eight hours postoperatively (last dose 44 hours after the first dose).
干预措施: Cefazolin (Drug)
Combination therapy, short course
One pre-op dose of cefazolin 30-60 minutes prior to surgery followed by a second dose either four hours after the first dose or upon wound closure (whatever comes first) will be administered. In addition, one dose of vancomycin 60-90min pre-op will be administered.
干预措施: Cefazolin (Drug)
Combination therapy, short course
One pre-op dose of cefazolin 30-60 minutes prior to surgery followed by a second dose either four hours after the first dose or upon wound closure (whatever comes first) will be administered. In addition, one dose of vancomycin 60-90min pre-op will be administered.
干预措施: Vancomycin (Drug)
Combination therapy, long course
One pre-op dose of cefazolin 30-60 minutes prior to surgery followed by a second dose either four hours after the first dose or upon wound closure (whatever comes first) will be administered followed by additional five doses every eight hours postoperatively (last dose 44 hours after the first dose). In addition, one dose of vancomycin 60-90min pre-op will be administered followed by 3 post-op doses every 12 hours (last dose 36 hours after first dose)
干预措施: Cefazolin (Drug)
Combination therapy, long course
One pre-op dose of cefazolin 30-60 minutes prior to surgery followed by a second dose either four hours after the first dose or upon wound closure (whatever comes first) will be administered followed by additional five doses every eight hours postoperatively (last dose 44 hours after the first dose). In addition, one dose of vancomycin 60-90min pre-op will be administered followed by 3 post-op doses every 12 hours (last dose 36 hours after first dose)
干预措施: Vancomycin (Drug)
结局指标
主要结局
Proportion of patients receiving antibiotics according to study protocol
时间窗: 3 months post-surgery
Co-Primary outcome of pilot study
Proportion of patients with complete follow-up, i.e. up to 90 days or death; goal >95%
时间窗: 3 months post-surgery
Co-Primary outcome of pilot study
Agreement of blinded outcome assessment based on information from the case report form
时间窗: 3 months post-surgery
Co-Primary outcome of pilot study
次要结局
- Deep incisional and organ/space sternal surgical site infection (NHSN/CDC)(3 months post-surgery)
- Clostridium difficile infection(3 months post-surgery)
- All types of sternal surgical site infection (superficial, deep, organ; NHSN/CDC)(3 months post-surgery)
- Mortality(3 months post-surgery)
研究者
Dominik Mertz
Assistant Professor, Medical Director Infection Prevention and Control
Hamilton Health Sciences Corporation