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
- 已完成
- 入组人数
- 426
- 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 determine 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
ChloraPrep Hi-Lite Orange
Apply 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 Hi-Lite Orange (Drug)
Normal Saline
Apply 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: Normal saline (Drug)
3M CHG/IPA Prep Tint 10.5 mL
Apply 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 10.5-mL (Drug)
3M CHG/IPA Prep Tint 26-mL
Apply 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 26-mL (Drug)
结局指标
主要结局
Responder Rate
时间窗: baseline, 10 minutes 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. 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.
次要结局
- Reduction of Skin Flora 10 Minutes Post-treatment(10 minutes)
- Safety as Assessed by Skin Irritation (Dryness, Edema, Erythema, Rash) Rating Score(Assessed at baseline (pre-treatment) and 10 minute post-treatment and 6 hour post-treatment.)
- Skin Flora Baseline for the Abdominal and Inguinal Region.(Baseline)
- Reduction of Skin Flora 6 Hours Post-treatment(6 hours)
- Skin Flora Recovery 6-hours Post-treatment(6 hours post-treatment)
- Skin Flora Recovery 10 Minutes Post-treatment(10 minutes post-treatment)