EUCTR2016-002692-98-GB进行中（未招募）1 期
An evaluation of the efficacy of HEXI-PREP by Clinell Wipes versus placebo and ChloraPrep, for use in pre-operative skin preparation - HEXI-PREP by Clinell Wipes
GAMA Healthcare0 个研究点目标入组 240 人开始时间: 2017年4月13日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 240
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Male and female participants 18-70 years, who have provided written informed consent to participate in the study.
- •2. Treatment sites with a bacterial baseline count greater or equal to 5 log10/cm(2) at the groin, and greater or equal to 3 log10/cm(2) at the clavicle and median cubital fossa of the arm of Day -5 of the study.
- •3. Participants, who in the opinion of the investigator, are in suitable health for inclusion in the study.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 240
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 240
排除标准
- •1. Participants who are exposed to topical antimicrobial agents, including medicated soaps, shampoos or lotions, who use biocide treated pools or hot-tubs, use tanning beds or sunbathing during the 14-day pre-test conditioning period or during the test period.
- •2. Exposure of the test sites to strong detergents, solvents or other irritants during the 14-day pre-test conditioning period or during the test period.
- •3. Use of systemic or topical antibiotic medications, steroid medications or any other product known to affect the normal microbial flora of the skin, up to 1 month prior to the screening period, during the 14-day pre-test conditioning period or during the test period.
- •4. Known allergies to latex (rubber), alcohols, tape adhesives or to common antibacterial agents found in soaps, lotions or ointments, particularly chlorhexidine gluconate or chlorine.
- •5. Female patients who are pregnant, become pregnant or are breast-feeding during the pre-test conditioning or during the test period.
- •6. Active skin rashes or breaks in the skin at the test site
- •7. Active skin diseases or inflammatory skin conditions including contact dermatitis within 10cm of the test site.
- •8. Showering or bathing after Day -5 baseline sampling and unwilling to refrain from showering or bathing whilst at Surrey CRC (Day 0 to Day 1)
- •9. Participation in another clinical trial within 90 days preceding randomisation
- •10. Any other medical condition, which in the Investigator's opinion, should preclude participation.
- •11. Unwillingness to fulfil the performance requirements of the study
研究者
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