NCT02530528已完成1 期
Pilot Trial Assessment of the Antimicrobial Efficacy of Medline 2% CHG Cloth Preoperative Skin Preparation
Medline Industries0 个研究点目标入组 27 人开始时间: 2014年2月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 27
- 主要终点
- Log Reduction of Bacterial Flora on Abdomen and Groin Sites
研究概览
简要总结
Pilot study to evaluate and compare activity of investigational preoperative preparation (2% CHG) with comparator (2% CHG).
详细描述
Evaluate and compare similar preoperative surgical preparations in healthy volunteers. Various application times were evaluated. Efficacy was assess using the Tentative Final Monograph (TFM) criteria.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •No dermatological conditions
排除标准
- •Sensitivity to CHG
- •Sensitivity to natural latex rubber or adhesive skin products
研究组 & 干预措施
2% CHG 1 min
Experimental
single administration, 1 min application time
干预措施: CHG (Drug)
2% CHG 2 min
Experimental
single administration, 2 min application time
干预措施: CHG (Drug)
2% CHG 3 min
Experimental
single administration, 3 min application time
干预措施: CHG (Drug)
Comparator 2% CHG
Active Comparator
Single administration, Marketed CHG
干预措施: CHG (Drug)
结局指标
主要结局
Log Reduction of Bacterial Flora on Abdomen and Groin Sites
时间窗: 10 min, 6 hr and 8 hr
Evaluate the Log Reduction of Normal Flora at various sites and timepoints
次要结局
未报告次要终点
研究者
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