Clinical Evaluation of the Antimicrobial Effectiveness of Topically Applied ZuraPrep
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 156
- 试验地点
- 1
- 主要终点
- Bacterial Reduction - Groin
研究概览
简要总结
The objective of the study is to demonstrate the antimicrobial efficacy of the Zurex Preoperative Prep (ZuraPrep - clear) on skin flora of the abdomen and inguinal regions of human subjects.
详细描述
The primary objective of this study is to measure the antimicrobial effectiveness of a single investigational test article, ZuraPrep™ as specified by the Healthcare Antiseptics, Topical Antimicrobial Drug Products Final Rule of December 20, 2017. The treatments will be ZuraPrep™ as the investigational test article, ChloraPrep® as an active control, and ZuraPrep™ Vehicle as a negative control. For efficacy at 30 seconds post-prep, the test article should be superior to the negative control using a margin of 1.2 log10 CFU/cm2 and non-inferior to the active control using a margin of 0.5 log10 CFU/cm2.
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 bacterial 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.
- •Taking antihistamines, immunosuppressants, or oral steroids within 14 days prior to screening and treatment days, excluding contraception or post-menopausal treatment.
- •Subjects with allergies to study materials including isopropyl alcohol or chlorhexidine gluconate.
- •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
ZuraPrep (70% IPA)
Isopropyl alcohol (IPA) 70%
干预措施: ZuraPrep Clear Solution (Drug)
ChloraPrep
Chlorhexidine gluconate (CHG) 2% / Isopropyl alcohol (IPA) 70%
干预措施: ChloraPrep (Drug)
ZuraPrep Vehicle
Zurex Prep without IPA
干预措施: ZuraPrep Vehicle (Drug)
结局指标
主要结局
Bacterial Reduction - Groin
时间窗: 30 seconds 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: 30 seconds post product application
A 2-log10 CFU/cm\^2 bacterial reduction on the abdomen region is considered a success.
次要结局
- Bacterial Counts Not Exceeding Baseline in the Abdomen and Groin Region(6 hours post product applcation)