Assessment of the Antimicrobial Efficacy of 2% CHG Cloth Preoperative Skin Preparation
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 340
- 试验地点
- 1
- 主要终点
- Responder Rates (%) of Sites Identified for Bacterial Reduction on the Abdomen and Groin
研究概览
简要总结
Evaluate the effects of Chlorhexidine Gluconate (CHG) cloth on the reduction of bacteria on the skin.
详细描述
Examine the antimicrobial cloth effects on normal flora bacteria of the abdomen and groin areas post Chlorhexidine Gluconate (CHG) application.
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
- 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
- 是
入选标准
- •Males or Females
- •18 years of age or older
- •Signed informed consent
- •Good Health
- •Six inches of abdomen and groin areas without tattoos, or skin disorders
排除标准
- •Dermatological Conditions
- •Sensitivity to latex
- •Sensitivity to CHG
研究组 & 干预措施
Chlorhexidine Gluconate Cloth
2% CHG, single application
干预措施: Chlorhexidine gluconate (Drug)
Vehicle Cloth
Excipients on cloth
干预措施: Vehicle (Other)
Active Chlorhexidine gluconate solution
Dynahex 2% CHG
干预措施: DynaHex-2 (Drug)
结局指标
主要结局
Responder Rates (%) of Sites Identified for Bacterial Reduction on the Abdomen and Groin
时间窗: 10 minutes, 6 hours, 8 hours
Log10 reduction in bacteria on the skin evaluated at 10 minutes, 6 hours and 8 hours after treatment. Responder rates (%) are the percentage of sites identified that produced a 2-Log and 3-Log reduction from baseline for abdomen and groin sites respectively.
次要结局
未报告次要终点