Antiseptic Skin Preparation for Preventing Surgical Site Infection at Cesarean Delivery: a Randomized Comparative Effectiveness Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,147
- 试验地点
- 1
- 主要终点
- Number of Participants With Surgical Site Infection
研究概览
简要总结
The investigators propose a randomized controlled clinical trial to determine the comparative effectiveness of chlorhexidine-alcohol and iodine-alcohol preoperative skin preparation for preventing surgical site infections at cesarean section. While estimates vary, surgical site infections complicate up to 5 - 10% of all cesarean sections and result in significant human suffering and excess health care costs. Interventions such as preoperative antibiotic prophylaxis reduce surgical site infections by 60%, but the rate of infection remains high. There is therefore a great need to identify and test other potential interventions to further reduce these infections.
The skin is a major source of pathogens that cause surgical site infection. Therefore, optimizing preoperative skin antisepsis has the potential to decrease postoperative surgical site infections. There is paucity of evidence to guide the choice of antiseptic for skin preparation at cesarean section. To date, only two underpowered trials have been published comparing two methods of preoperative skin preparation at cesarean section. A recent randomized trial in adults undergoing clean-contaminated mostly general surgical procedures demonstrated a 41% reduction in surgical site infection with the use of chlorhexidine-alcohol when compared to the more commonly used povidone-iodine. While it is plausible that findings from trials in other clean-contaminated surgical procedures may apply to cesarean sections, physiological changes in pregnancy, the peculiar dual microbial source for cesarean-related infections and the hormone-mediated immune-modulation in pregnancy make the validity of such extrapolation uncertain.
The study has the following specific aims:
Primary Aim: To test the hypothesis that preoperative chlorhexidine-alcohol skin preparation at cesarean section significantly reduces surgical site infections compared to iodine-alcohol.
Secondary Aim 1: To test the hypothesis that preoperative chlorhexidine-alcohol skin preparation at cesarean section significantly reduces bacterial contamination at the surgical site compared to iodine-alcohol.
Secondary Aim 2: To determine clinical outcomes and medical costs associated with cesarean-related infections and quantify potential cost savings attributable to use of chlorhexidine-alcohol for preoperative skin preparation at cesarean section.
详细描述
RESEARCH DESIGN AND METHODS
This will be a randomized controlled clinical trial aimed at determining the comparative effectiveness of chlorhexidine-alcohol and iodine-alcohol preoperative skin preparation for preventing surgical site infection at cesarean section.
The investigators will use broad inclusion criteria and analyze all the main outcomes by the intent-to-treat principle. This approach will allow a more conservative estimate of differences between groups and allow a better estimate of effectiveness and public health implications of practice change rather than a pure estimate of efficacy alone.
Randomization and Treatment: Enrolled patients will be randomly assigned in a 1:1 ratio using computer-generated randomization sequence to the two skin preparation methods.
Blinding: Blinding both patients and physicians to the antiseptic used for skin preparation (double-blinding) would be ideal. However, it is not feasible in this trial. First, most patients can determine whether they were assigned to chlorhexidine or iodine, as the two antiseptics are of different colors and leave a stain on the skin (pink or brown, respectively). Second, physicians are often in the operating room when the skin is being prepared for cesarean section and will know which antiseptic is used. We will minimize systematic bias by using the same standard procedures of skin preparation, skin culture and assessment of outcomes. All diagnoses of surgical site infection will be verified by chart review using the Centers for Disease Control and Prevention (CDC) National Nosocomial Infections Surveillance System criteria. The principal investigator will verify the diagnoses without knowledge of the group to which the patients were assigned.
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
- None
入排标准
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Women undergoing cesarean delivery at Barnes-Jewish Hospital.
排除标准
- •Inability to obtain consent; allergy to chlorhexidine, alcohol, iodine, shellfish; and evidence of infection adjacent to operative site.
研究组 & 干预措施
Iodine-alcohol
8.3% povidone-iodine with 72.5% alcohol (Prevail-FX, Cardinal Health)
干预措施: Iodine-alcohol (Drug)
Chlorhexidine-alcohol
2% chlorhexidine gluconate with 70% alcohol (ChloraPrep, Cardinal Health)
干预措施: Chlorhexidine-alcohol (Drug)
结局指标
主要结局
Number of Participants With Surgical Site Infection
时间窗: 30 days
Superficial or deep surgical-site infection within 30 days after cesarean delivery, on the basis of the National Healthcare Safety Network definitions of the Centers for Disease Control and Prevention.
次要结局
- Number of Participants With Skin Contamination After Skin Prep(1 day)
- Number of Participants With Re-admissions or Office Visits for Wound-related Problems(30 days)
- Number of Participants With Allergic Reaction(30 days)
- Length of Hospital Stay(30 days)
- Number of Participants With Endometritis(30 days)
- Number of Participants With Skin Irritation(30 days)
- Cost Savings(30 days)