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
- 发起方
- 3M
- 入组人数
- 738
- 试验地点
- 1
- 主要终点
- Responder Rate
研究概览
简要总结
The objective of this study is to demonstrate 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 site, a responder is defined as a subject with a 2-log10/cm2 bacterial reduction at 10 minutes and for whom the skin flora does not return to baseline at 6 hours.
On the inguinal site, a responder is defined as a subject with a 3-log10/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 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 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
3M CHG/IPA Prep C
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 C (Drug)
3M CHG/IPA Prep CH
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 CH (Drug)
ChloraPrep
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 (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)
结局指标
主要结局
Responder Rate
时间窗: baseline, 10 minutes post-product application and 6 hours post-product application
On the abdominal region a responder is a subject with a 2 log10/cm\^2 bacterial reduction at 10 minutes and for whom the skin flora does not return to baseline at the 6-hour sample collection time. On the inguinal region a responder is a subject with a 3 log10/cm\^2 bacterial reduction at 10 minutes and for whom the skin flora does not return to baseline at the 6-hour sample collection time.
Alternative Primary
时间窗: Baseline and 10 minutes
10 minute log reduction
次要结局
- Reduction of Skin Flora 6 Hours Post-treatment(6 hours)
- Skin Flora Baseline for the Abdomen and Inguinal Region.(Baseline)
- Skin Flora Recovery 10 Minutes Post-treatment(10 minute post-product application)
- Safety as Assessed by Skin Irritation (Dryness, Edema, Erythema, Rash) Rating Score(Baseline)
- Safety Assessed as Skin Irritation (Dryness, Edema, Erythema, Rash) Rating Score(10 minutes post-treatment)
- Safety as Assessed by Skin Irritation Score(6 hours post-treatment)
- Reduction of Skin Flora 10 Minutes Post-treatment(10 minutes)
- Skin Flora Recovery 6-hours Post-treatment(6 hours post-treatment)