NCT02530554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 14 人开始时间: 2015年7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
- 14
- 主要终点
- Log Change in Bacterial Flora on Abdomen and Groin
研究概览
简要总结
Pilot study to evaluate and compare activity of CHG preoperative preparation with comparator CHG
详细描述
Evaluate and compare similar preoperative surgical preparations in healthy volunteers. Efficacy was assess using Tentative Final Monograph (TFM) criteria.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 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
- •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
CHG Cloth
Experimental
3 min application time
干预措施: CHG (Drug)
Comparator CHG
Active Comparator
Marketed 2% CHG
干预措施: CHG (Drug)
结局指标
主要结局
Log Change in Bacterial Flora on Abdomen and Groin
时间窗: 10 min, 6 hr and 8 hr
Change was calculated as the baseline time point minus the later time points over an 8 hour period.
次要结局
未报告次要终点
研究者
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