Chlorhexidine-Alcohol Versus Povidone-Iodine for Surgical-Site Antisepsis:A Prospective, Randomized, Multicenter Clinical Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 849
- 试验地点
- 6
- 主要终点
- The Primary Objective of This Trial is to Compare the Impact of Disinfecting the Skin With Chloraprep vs. Betadine on the Rates of Infection of Clean-contaminated Surgical Wounds.
研究概览
简要总结
Most cases of infection of clean-contaminated wounds (wounds without gross spillage of organisms from the gastrointestinal tract) are thought to originate from the skin. Therefore, it is conceivable that application of an optimal antiseptic agent can reduce the rate of surgical wound infections. This trial is to compare the impact of disinfecting the skin with Chloraprep (2%chlorhexidine and 70% isopropyl alcohol) vs. Betadine on the rates of infection of clean-contaminated surgical wounds. The study will also assess the occurrence of adverse effects on the skin from either antiseptic agent and the cost-savings associated with the use of Chloraprep vs Betadine.
详细描述
This is a prospective, randomized, multicenter clinical trial. All adult patients, who are scheduled for a clean-contaminated surgical procedure of the alimentary, respiratory, reproductive or urinary tract will be asked to participate.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- Double (Participant, 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
- •Adult patients who are scheduled for a clean-contaminated surgical procedure of the alimentary or respiratory tract will be eligible for participation. A clean-contaminated wound is one that is entered under controlled conditions without unusual contamination.
排除标准
- •Patients will be excluded form the study if: (1) they are unable or unwilling to give informed consent; (2) the patient is less than 18 years of age; (3) there is evidence of pre-existing infection at or adjacent to the operative site; (4) a break in sterile technique occurs; (5) the patient has a history of allergy to chlorhexidine, alcohol or iodophors.
研究组 & 干预措施
povidone-iodine
preoperative skin preparation with povidone-iodine
干预措施: Povidone-Iodine (Drug)
chlorhexidine-alcohol
preoperative skin preparation with scrub and paint technique
干预措施: chlorhexidine-alcohol (Drug)
结局指标
主要结局
The Primary Objective of This Trial is to Compare the Impact of Disinfecting the Skin With Chloraprep vs. Betadine on the Rates of Infection of Clean-contaminated Surgical Wounds.
时间窗: during surgery and within the 30 days post surgery
The primary end point of the study was the occurrence of any surgical-site infection. Diagnosis of surgical-site infection was diagnosed by a blinded reviewer following criteria developed by the Center for Disease Control. The significance of difference between the two study groups in terms of patient characteristics was determined with the use of the Wilcoxon rank-sum test for continuous variables and Fisher's exact test for categorical variables. For efficacy outcomes, we compared the proportions of patients in the two study groups who could be evaluated and who any type of surgical-site infection using Fisher's exact test and calculating the relative risk of infection and 95% confidence intervals. To determine whether the results were consistent across the 6 participating hospitals, a prespecified Breslow-Day test for homogeneity was performed.
次要结局
未报告次要终点
研究者
Rabih Darouiche
Professor of Medicine
Baylor College of Medicine