NCT00692484已完成3 期
Pilot Evaluation of the Effect of Application Procedure on the Antimicrobial Effects of an Aqueous CHG and a Traditional Iodophor Scrub Paint
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- C. R. Bard
- 入组人数
- 122
- 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
Evaluate effect of application procedure on efficacy of 2 antiseptics for cleaning skin prior to surgery.
详细描述
Evaluate the effect of application procedure on the antimicrobial properties of a new product and a currently marketed product. Study will be conducted using methods dictated by the FDA.
Study uses topical sampling from the abdomen and groin on intact skin and evaluates the germs. Effects of blotting versus not blotting will be assessed.
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
- None
入排标准
- 年龄范围
- 18 Years 至 90 Years（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 around test sites
- •must not have received topical or systemic antimicrobials, antibiotics, or steroids for 7 days prior to testing and 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 7 day pre-test period or during the test period
- •exposure of the test sites to strong detergents, solvents, or other irritants during the 7 day pre-test period or during the test period
- •use of systemic or topical antibiotic medications, steroid medications, or any other product known to affect the normal microbial flora of the skin during the 7 day pre-test period or during the test period
- •known allergy to latex (rubber), alcohols, inks, or tape adhesives, or to common antibacterial agents found in soaps, lotions, or ointments, particularly chlorhexidine gluconate and povidone iodine
- •active skin rashes or breaks in the skin of the test sites
- •currently active skin disease or inflammatory skin condition, including contact dermatitis
- •showering or bathing within the 72 hour period prior to sampling
- •participation in a clinical study in the past 7 days or current participation in another clinical study
研究组 & 干预措施
1
Experimental
Chlorhexidine gluconate 2%
干预措施: Chlorhexidine gluconate (Drug)
2
Active Comparator
Povidone iodine scrub and paint
干预措施: Povidone iodine (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
- Impact of blotting versus not blotting(Blotting and not blotting after 2 minute application with CHG and 5 minute application of iodophor)
研究者
研究点 (1)
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