Assessment of the Antimicrobial Efficacy of 3M CHG/IPA Preoperative Skin Preparation Against Resident Human Skin Flora on the Abdominal and Inguinal Regions
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 171
- 试验地点
- 1
- 主要终点
- Responder Rate
研究概览
简要总结
The purpose of this study is to evaluate the antimicrobial efficacy of the 3M CHG/IPA Prep on skin flora of the abdominal and inguinal regions of human subjects.
详细描述
The primary efficacy is evaluated by demonstration that the product provides a lower bound of the 95% confidence interval of percent responders that is greater than or equal to 70%. On the abdominal sites, a responder is defined as a subject with a 2-log10 per cm2 bacterial reduction at 10 minutes and for whom the skin flora does not return to baseline at 6 hours. On the inguinal sites, a responder is defined as a subject with a 3-log10 per cm2 bacterial reduction at 10 minutes and for whom the skin flora does not return to baseline at 6 hours.
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 general health
- •Minimum skin flora baseline requirements on abdomen and groin
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 areas
- •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
3M CHG/IPA Prep Colorless
Applied topically for 30 seconds to the abdominal region or 2 minutes to the inguinal region, and allow to dry for 3 minutes.
干预措施: 3M CHG/IPA Prep Colorless (Drug)
3M CHG/IPA Prep Tint
Applied topically for 30 seconds to the abdominal region or 2 minutes to the inguinal region, and allow to dry for 3 minutes.
干预措施: 3M CHG/IPA Prep Tint (Drug)
ChloraPrep Hi-Lite Orange
Applied topically for 30 seconds to the abdominal region or 2 minutes to the inguinal region, and allow to dry for 3 minutes.
干预措施: ChloraPrep (Drug)
Normal Saline
Applied topically for 30 seconds to the abdominal region or 2 minutes to the inguinal region, and allow to dry for 3 minutes.
干预措施: Saline (Drug)
结局指标
主要结局
Responder Rate
时间窗: baseline, 10 minute post-product application and 6 hour post-product application
On the abdominal region a responder was a subject with a 2-log10/cm2 bacterial reduction at 10 minutes and for whom the skin flora did not return to baseline at 6 hours. On the inguinal region a responder was a subject with a 3-log10/cm2 bacterial reduction at 10 minutes and for whom the skin flora did not return to baseline at 6 hours.
Skin Flora Baseline for Abdominal and Inguinal Regions
时间窗: Baseline
Log10/cm2 baseline skin flora for abdominal and inguinal regions
Skin Flora Recovery Post-treatment
时间窗: 10 minutes and 6 hours post-treatment
Log10/cm2 recovery of skin flora at 10 minutes and 6 hours following application of study treatments for abdominal and inguinal regions
Reduction of Skin Flora Post-treatment
时间窗: Baseline, 10 minutes and 6 hours
Log10/cm2 reduction of skin flora, relative to Treatment Day baseline log10/cm2, at 10 minutes and 6 hours
次要结局
- Safety as Assessed by Skin Irritation Scores(6 hours post-treatment)