An Evaluation of the Efficacy of HEXI-PREP by Clinell Wipes Versus Placebo and Chloraprep, for Use in Preoperative Skin Preparation
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 93
- 试验地点
- 1
- 主要终点
- Reduction of bacterial load at each test site.
研究概览
简要总结
This study evaluates the antimicrobial properties of HEXI-PREP by Clinell compared to both a negative and a positive control product.
详细描述
HEXI-PREP by Clinell is a sterile single sachet wipe containing chlorhexidine gluconate and isopropyl alcohol. Both active ingredients are well-established ingredients commonly used for their disinfectant properties.
This trial is designed to assess the superiority of HEXI-PREP by Clinell Wipe against a negative control, and also to demonstrate the relative efficacy of HEXI-PREP by Clinell WIpe against a similar commercially available product.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male and female participants 18 - 70 years, who have provided written informed consent to participate in the study
- •Test sites with a bacterial baseline count of ≥ 5.0 log10/cm2 at the inguinal (groin) test administration sites. ≥4.0 log10/cm2 at the abdominal test site and >3.0 log10/cm2 at the clavicular and/or median cubital regions at Day - 5 of screening
- •Participants, who in the opinion of the Investigator, are in suitable health for inclusion in the study.
排除标准
- •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.
- •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.
- •Any known allergies to latex (rubber), alcohols, tape adhesives or to common antibacterial agents found in soaps, lotions or ointments, particularly chlorhexidine gluconate or chlorine.
- •Active skin rashes or breaks in the skin at the test site.
- •Active skin diseases or inflammatory skin conditions including contact dermatitis within 10cm of the test site.
- •Showering or bathing after the Day -5 baseline sampling and unwilling to refrain from showering or bathing whilst at Surrey CRC (Day 0 to Day 1).
- •Participation in another clinical trial within 90 days preceding randomisation.
- •Pregnant or breastfeeding women.
- •Any other medical condition, which in the opinion of the Investigator, should preclude participation.
- •Unwillingness to fulfil the performance requirements of the study.
研究组 & 干预措施
HEXI-PREP By Clinell Wipes vs Placebo
Both trial products will be applied bilaterally to between one and four predetermined anatomical sites on each participant, depending on whether the inclusion criteria for bioburden has been met for each sampling site. Each site will be sampled for bacterial load at four predetermined time points.
干预措施: HEXI-PREP By Clinell Wipes (Drug)
HEXI-PREP By Clinell Wipes vs Placebo
Both trial products will be applied bilaterally to between one and four predetermined anatomical sites on each participant, depending on whether the inclusion criteria for bioburden has been met for each sampling site. Each site will be sampled for bacterial load at four predetermined time points.
干预措施: Placebos (Drug)
HEXI-PREP By Clinell Wipes vs Chloraprep
Both trial products will be applied bilaterally to between one and four predetermined anatomical sites on each participant, depending on whether the inclusion criteria for bioburden has been met for each sampling site. Each site will be sampled for bacterial load at four predetermined time points.
干预措施: HEXI-PREP By Clinell Wipes (Drug)
HEXI-PREP By Clinell Wipes vs Chloraprep
Both trial products will be applied bilaterally to between one and four predetermined anatomical sites on each participant, depending on whether the inclusion criteria for bioburden has been met for each sampling site. Each site will be sampled for bacterial load at four predetermined time points.
干预措施: Chloraprep (Drug)
Chloraprep vs Placebo
Both trial products will be applied bilaterally to between one and four predetermined anatomical sites on each participant, depending on whether the inclusion criteria for bioburden has been met for each sampling site. Each site will be sampled for bacterial load at four predetermined time points.
干预措施: Chloraprep (Drug)
Chloraprep vs Placebo
Both trial products will be applied bilaterally to between one and four predetermined anatomical sites on each participant, depending on whether the inclusion criteria for bioburden has been met for each sampling site. Each site will be sampled for bacterial load at four predetermined time points.
干预措施: Placebos (Drug)
结局指标
主要结局
Reduction of bacterial load at each test site.
时间窗: 1 and 10 minutes after application.
Reduction in bacterial load of the test product in comparison to a negative control.
次要结局
- Persistence of reduction in bacterial load at each test site.(30 minutes - 24 hours)
- Relative efficacy compared to a positive control(1-10 minutes, and 30 minutes - 24 hours)
- Number of participants with treatment-related adverse events as assessed by a 5-point scale based on comment from the participant, and recorded assessments of erythema and oedema.(From application)