Clinical Evaluation of the Antimicrobial Effectiveness of Topically Applied ZP
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 440
- 试验地点
- 1
- 主要终点
- Bacterial Reduction
研究概览
简要总结
The objective of the study is to demonstrate the antimicrobial efficacy of the ZP Preoperative Prep on skin flora of the abdomen and inguinal regions of human subjects.
详细描述
The purpose of this study is to evaluate the antimicrobial properties of one finished test product (ZP) with a positive control (CP) and a negative control (ZP™ Vehicle without IPA) when used as a patient preoperative skin preparation.
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
- •Skin free of tattoos, dermatoses, abrasions, cuts, lesions, or other skin disorder near or on the applicable test area.
排除标准
- •Topical or systemic antimicrobial exposure within 14 days prior to screening and treatment days, including antibiotics.
- •Subjects with a history of skin sensitivity, skin allergies, or skin cancer.
- •Subjects who are pregnant, attempting pregnancy or nursing.
研究组 & 干预措施
ZP (70% IPA)
Isopropyl alcohol (IPA) 70%
干预措施: ZuraPrep (Drug)
ChloraPrep
Chlorhexidine gluconate (CHG) 2% / Isopropyl alcohol (IPA) 70%
干预措施: ChloraPrep (Drug)
ZP Vehicle
ZP without IPA
干预措施: ZP Vehicle (Drug)
结局指标
主要结局
Bacterial Reduction
时间窗: 10 minutes post product application
A 3-log10 CFU/cm\^2 bacterial reduction on the inguinal region is considered a success.
Bacterial Reduction - Abdomen
时间窗: 10 minutes post product application
A 2-log10 CFU/cm\^2 bacterial reduction on the abdomen region is considered a success.
次要结局
未报告次要终点