Assessment of the Antimicrobial Efficacy of 3M™ SoluPrep™ Preoperative Skin Preparation Against Resident Human Skin Flora on the Inguinal Region
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 154
- 试验地点
- 1
- 主要终点
- Log Change (Reduction) in Skin Flora on the Inguinal Region at 6 Hours
研究概览
简要总结
The purpose of this study is to determine the antimicrobial efficacy of an investigational CHG/IPA prep on skin flora of the inguinal regions of human subjects.
详细描述
Non-inferiority of the investigational product to the FDA-approved active control for log10/cm2 recovery of skin flora relative to Treatment Day baseline log10/cm2 on the inguinal region at 10 minutes following application. Non-inferiority is based on a non-inferiority margin of 0.5 log10/cm2.
Superiority of the active products to the negative control for log10/cm2 recovery of skin flora relative to Treatment Day baseline log10/cm2 on the inguinal region at 10 minutes following application. A superiority margin of 1.2 log10/cm2 is used.
Number of observations for which the log10/cm2 recovery of skin flora on the inguinal region at 6 hours following application of the study products is higher than treatment day log10/cm2 baseline skin flora.
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
- •Subjects of any race
- •Subjects in good health
- •Minimum skin flora baseline requirements on inguinal region
排除标准
- •Any tattoos, scars, breaks in the skin, or any form of dermatitis, or other skin disorders (including acne) on the applicable test area
- •Topical antimicrobial exposure within 14 days prior to screening and treatment days
- •Use of systemic or topical antibiotics, steroid medications, or any other products known to affect the normal microbial flora of the skin within 14 days prior to screening and treatment days
研究组 & 干预措施
CHG/IPA Surgical skin preparation
Apply topically to the inguinal region for 2 minutes
干预措施: CHG/IPA Surgical skin preparation (Drug)
CHG/IPA Film-Forming Surgical skin preparation
Apply topically to the inguinal region for 2 minutes
干预措施: CHG/IPA Surgical skin preparation (Drug)
Normal saline
Apply topically to the inguinal region for 2 minutes
干预措施: Normal saline (Drug)
结局指标
主要结局
Log Change (Reduction) in Skin Flora on the Inguinal Region at 6 Hours
时间窗: 6 hours
Persistent efficacy endpoint which is a binary endpoint with success/failure, where "success" is defined as log10 CFU/cm2 of skin flora on the inguinal region at 6 hours following application of the study products being lower than the treatment day baseline skin flora
Log Change (Reduction) in Skin Flora on the Inguinal Region at 10 Minutes
时间窗: 10 minutes
Immediate efficacy endpoint which is defined as the average treatment effect (ATE) log10 CFU/cm2 of skin flora on the inguinal region at 10 minutes following application of the study products relative to the treatment day baseline skin flora
次要结局
未报告次要终点