Preoperative Skin Preparation Evaluation of One Test Product With a Positive and a Negative Control
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- C. R. Bard
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- 3.0 log10 reduction in CFU/cm2 on inguinal sites, and 2.0 log10 reduction in CFU/cm2 on abdominal sites
研究概览
简要总结
Determine the antimicrobial properties of a proposed new product and an already approved product and a placebo (no drug). Study will be conducted using methods dictated by the FDA.
详细描述
Determine the antimicrobial properties of a proposed new product and an already approved product and a placebo (no drug). Study will be conducted using methods dictated by the FDA.
This study uses topical sampling from the abdomen and the groin on intact skin and evaluates the germs left on the skin after treatment with the proposed new product, the currently approved product and the placebo.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Free of dermatoses, cuts, lesions, or other skin disorders on or around the test sites; no exposure to topical or systemic antimicrobials, antibiotics, or steroids (other than contraceptives, for the fourteen (14) day pre-test conditioning period and must agree to abstain from these materials until completion of the study
排除标准
- •Exposure of test sites to antimicrobial agents, medicated soaps, medicated shampoos, or medicated lotions,
- •Use of biocide-treated pools or hot tubs, use of tanning beds, or sunbathing during the fourteen(14) day pre-test conditioning period or during the test period;
- •Exposure of the test sites to strong detergent, solvents, or other irritants during the fourteen (14) day pre-test conditioning period or during the test period;
- •Use of systemic or topical antibiotic medications, steroid medications other than contraceptives, or any other product known to affect the normal microbial flora of the skin during the fourteen ()14) day pre-test conditioning period or during the test period;
- •Know of allergies to vinyl, latex (rubber), alcohols, metals, inks, or tape adhesives, or to common antibacterial agents found in soaps, lotions, or ointments, particularly chlorhexidine gluconate, and/or isopropyl alcohol;
- •A medical diagnosis of a physical condition, such as a current or recent severe illness, asthma, diabetes, hepatitis, an organ transplant, any immunocompromised conditions such as AIDS (or HIV positive), mitral valve prolapse, or a requirement to take antibiotics prior to dental procedures;
- •Pregnancy, plans to become pregnant within the pre-test and test periods of the study, or nursing a child;
- •Any active skin rashes or breaks in the skin of the test sites;
- •A currently active skin disease or inflammatory skin condition, including contact dermatitis; showering or bathing within the seventy-two (72) hour period prior to sampling; participation in another clinical study in the past thirty (30) days or current participation in another clinical study;
- •Any medical condition or use of any medications, that, in the opinion of the Study Director, should preclude participation;
- •Unwillingness to fulfill the performance requirements of the study.
研究组 & 干预措施
CHG 2%-26 ml
Chlorhexidine gluconate in an aqueous base, 26 ml applicator
干预措施: Chlorhexidine gluconate (Drug)
ChloraPrep 26 ml
ChloraPrep One-Step 26 ml Active drug contains chlorhexidine gluconate and alcohol
干预措施: ChloraPrep One Step (Drug)
Sterile Saline
Sterile salt water administered topically.
干预措施: Sterile saline (Drug)
结局指标
主要结局
3.0 log10 reduction in CFU/cm2 on inguinal sites, and 2.0 log10 reduction in CFU/cm2 on abdominal sites
时间窗: 10 minutes and 6 hours after application of test solutions
次要结局
未报告次要终点