Test for Pre Operative Skin Preparations: ChloraPrep Triple Swabsticks, Hibiclens and Sterile Triple Swabsticks (Using Sterile Deionized Water)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- C. R. Bard
- 入组人数
- 335
- 试验地点
- 1
- 主要终点
- log10 Reductions From Baseline for Each Test Parameter in CFU (Colony Forming Unit)/cm2 on Inguinal and Abdominal Sites
研究概览
简要总结
Compare 2 application techniques of ChloraPrep Swabstick--3 swabsticks at once versus 3 swabsticks used sequentially. Hibiclens applied according to the manufacturer's directions. Sterile swabsticks (wetted with sterile deionizd water) applied using the same method as the ChloraPrep Swabstick.
详细描述
Determine differences (if any) in 2 different application techniques of ChloraPrep Swabstick--3 swabsticks at once versus 3 swabsticks used sequentially. Hibiclens, a liquid antibacterial soap, applied according to the manufacturer's directions as a active/positive comparison. Sterile swabsticks (wetted with sterile deionized water) applied as a negative comparison using the same method as the ChloraPrep swabstick.
Study uses topical sampling from the abdomen and the groin on intact skin and evaluates the germs left on the skin after treatment with ChloraPrep Swabsticks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects must read and sign an Informed Consent Form and be cooperative.
- •Subjects must be in good general health.
- •Subjects must have skin within 6 inches of the test site that is free of tattoos, dermatoses, abrasions, cuts, lesions, or other skin disorders.
排除标准
- •Use of systemic or topical antimicrobials during the 2-week pretest conditioning period. This restriction includes but is not limited to shampoos, lotions, soaps, baby powders, and materials, such as solvents, acids, or alkalis.
- •A medical diagnosis of a physical condition, which would preclude participation such as: diabetes, hepatitis, an organ transplant, a medical surgical implant, or an immunocompromised system.
- •Any medical condition that in the opinion of the investigator would preclude participation.
- •Bathed in chemically treated pools or hot tubs 2 weeks prior to any microbial sampling.
- •Used UV tanning lamps 2 weeks prior to any microbial sampling.
- •Bathing or showering less than 48 hours prior to any microbial sampling.
- •Known sensitivity to chlorhexidine gluconate.
- •Known sensitivity to latex (rubber).
- •Known sensitivity to fragrances.
- •Pregnant or nursing.
- •Unwillingness to fulfill the performance requirements of the study.
- •Subjects who have completed part or all of the study will not be reentered in the study.
研究组 & 干预措施
CHG Swabstick sequential
Chlorhexidine gluconate (CHG) 2% w/v and isopropyl alcohol (IPA) 70% v/v - 3 swabsticks applied sequentially
干预措施: CHG 2% w/v & IPA 70% v/v swab applied sequentially (Drug)
CHG Swabstick (3 @ once)
Chlorhexidine gluconate (CHG) 2% w/v CHG/isopropyl alcohol (IPA) 70% v/v - 3 swabsticks applied @ same time
干预措施: CHG 2% w/v & IPA 70% v/v, swabstick (3 @ once). (Drug)
Hibiclens
Chlorhexidine gluconate (CHG) 4% w/v in an aqueous base
干预措施: Aqueous CHG 4% w/v applied according to mfr's directions (Drug)
Sterile water swab (3 @ once)
Sterile swabstick wetted with sterile deionized water - 3 swabsticks applied at the same time.
干预措施: Sterile swabstick with sterile water (3 @ once) (Other)
Sterile water swabstick (sequential)
Sterile swabstick wetted with sterile water--3 swabsticks applied sequentially.
干预措施: Sterile swabstick with sterile water (one-at-a-time) (Other)
结局指标
主要结局
log10 Reductions From Baseline for Each Test Parameter in CFU (Colony Forming Unit)/cm2 on Inguinal and Abdominal Sites
时间窗: 10 minutes and 6 hours after application of test solutions
The bacterial reductions achieved by the test products and the controls using 2 different application techniques at 10-minute and 6-hour sampling intervals for both groin and abdominal sites were evaluated.
次要结局
未报告次要终点