Assessment of Antimicrobial Persistence of 3M CHG/IPA Preoperative Skin Preparation Against Resident Flora on the Abdominal and Inguinal Regions
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 27
- 试验地点
- 1
- 主要终点
- Measurement of Skin Flora Recovery Post-prep Application Relative to Baseline
研究概览
简要总结
The objective of the study is to demonstrate persistence of the CHG/IPA Prep on skin flora of the abdominal and inguinal regions of human subjects.
详细描述
The objective of the study is to demonstrate persistence of the CHG/IPA Prep versus a saline placebo on skin flora of the abdominal and inguinal regions of human subjects as measured by change in microbial flora relative to baseline.
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 - Abdominal Region
Apply Chlorhexidine (CHG) 2% / Isopropyl alcohol (IPA) 70% for 30 seconds and allow to dry for 3 minutes.
干预措施: 3M CHG/IPA Surgical Skin Preparation - Abdominal Region (Drug)
Normal Saline - Abdominal Region
Apply 0.9% sodium chloride with applicator for 30 seconds and allow to dry for 3 minutes.
干预措施: Normal Saline - Abdominal Region (Other)
3M CHG/IPA - Inguinal Region
Apply Chlorhexidine (CHG) 2% / Isopropyl alcohol (IPA) 70% for 30 seconds and allow to dry for 3 minutes.
干预措施: 3M CHG/IPA Surgical Skin Preparation - Inguinal Region (Drug)
Normal Saline - Inguinal Region
Apply 0.9% sodium chloride with applicator for 30 seconds and allow to dry for 3 minutes.
干预措施: Normal Saline - Inguinal Region (Other)
结局指标
主要结局
Measurement of Skin Flora Recovery Post-prep Application Relative to Baseline
时间窗: Baseline, 48 hours and 72 hours post-prep application
The primary measure of persistence is the suppression of regrowth recovery relative to baseline (log10 CFU/cm\^2) of skin flora at two defined post-prep sampling times relative to baseline.
次要结局
- Safety as Assessed by Skin Irritation Scores Coded by Study Staff(48 hours and 72 hours post-product application)
- Safety as Assessed by Adverse Events(To 72 hours post treatment)