Evaluation of Antimicrobial Efficacy of Two Hand Hygiene Products in ICUs Using Hand Prints
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 51
- 试验地点
- 1
- 主要终点
- Bacterial Colony Forming Units Present on Hand Prints After Time Spent in Common Areas
研究概览
简要总结
This study will evaluate the immediate antimicrobial efficacy and persistence of two hand hygiene products on ICU Health Care Worker's skin flora by measuring bacterial organisms on hands using the hand print method. It is hypothesized that the product containing Chlorhexidine gluconate will provide more persistence than the alcohol product, resulting in less bacterial growth on the hand print plates. In addition, environmental monitoring for cleanliness will be captured from high touch surfaces in ICU patient rooms and common areas using Rodac plates and adenosine triphosphate tests.
详细描述
Crossover study with 50 Health care workers using each product with a minimum of 3 days in between. Products will be applied twice as per manufacturer's instructions for a Healthcare Personnel Handwash followed by immediate hand print. Persistent hand prints will be collected after exposure to environmental contaminants in the common areas. Hand prints will also be collected from one hand of 60 patients cared for by a participating Health Care Worker and gloved hand of Health Care Worker. All media contain neutralizers to inactivate active ingredients in each product and on surfaces. Each hand print plate's area of growth will be measured for Colony Forming Units using computerized software.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
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
- •HCW willing to participate in the study
- •HCW willing to use non-Triclosan soap when soap is necessary throughout the study
- •HCW who will don gloves prior to ICU patient room entry
排除标准
- •Use of any CHG -containing products ( liquid hand soap, Sage wipes) on the ICU 72 hours prior to study initiation and throughout study
- •HCW with patient bandage or other dressing on palm(s)
- •Known sensitivity or allergy to CHG or alcohols in hand hygiene products
- •Known sensitivity or allergy to the following components: Lecithin, Polysorbate 80,Trypticase Soy Agar, sodium bisulfate, sodium thioglycollate, sodium thiosulfate
- •History of skin allergies
研究组 & 干预措施
Alcohol hand sanitizer foam
Alcohol foam hand sanitizer applied with 1 pump into hands, spread over hands up to the wrist and rubbed until dry. Foam will be applied twice approximately 15-30 minutes apart on one day.
干预措施: Alcohol hand sanitizer foam (Drug)
hand antiseptic with CHG and alcohol
Hand antiseptic is applied by dispensing 1 pump into hands, spreading over the hands up to the wrist, and rubbing until dry. Hand antiseptic will be used twice approximately 15-30 minutes apart on one day.
干预措施: hand antiseptic with CHG and alcohol (Drug)
结局指标
主要结局
Bacterial Colony Forming Units Present on Hand Prints After Time Spent in Common Areas
时间窗: On each of 2 days, Hand print plates collected from one hand immediately after product use (T0) and from other hand after time spent in MICU common areas
Hand print plates will be collected from HCWs immediately after use of hand hygiene product and after time spent in common areas. Each HCW will use both products at least 3 days apart. Hand print plates from each product for each HCW will be compared.
次要结局
未报告次要终点