Chlorhexidine Impregnated Cloths to Prevent Skin and Soft Tissue Infections in Marine Officer Candidates: A Randomized, Double-Blind, Placebo-Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,563
- 试验地点
- 1
- 主要终点
- The rate of skin and soft tissue infections among platoons enrolled in OCS.
研究概览
简要总结
Outbreaks of skin and soft tissue infections (SSTI) related to community associated Methicillin-resistant Staphylococcus aureus (MRSA) have become increasingly common in military training units. Risk factors for MRSA related SSTI such as crowding, poor hygiene and shared equipment are often hard to avoid in a military training environment, often designed to simulate battlefield conditions.
It has recently been demonstrated that military recruits colonized with MRSA may be at increased risk of developing SSTI. Studies in the hospital environment have shown that decolonizing inpatients known to carry MRSA decreases the rates of MRSA related infections in the treated individuals and also in their inpatient unit as a whole.
The investigators propose a randomized, double blind, placebo controlled trial to:
- Evaluate the effectiveness, feasibility, and safety of chlorhexidine body cloths, self-administered three times weekly, in preventing SSTI among recruits in military training facilities; and
- Evaluate the effectiveness of chlorhexidine body cloths in decreasing rates of Staphylococcus aureus colonization among military recruits.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Enrolled in US Marine Officer Candidates School
- •Age 18-35 years
- •Provide documented informed consent and HIPAA authorization
排除标准
- •Is currently taking oral antibiotics and will continue to take antibiotics during the study (such as antibiotics used to treat acne)
- •Has a known or suspected allergy or intolerance to chlorhexidine (Hibistat, Hibiclens)
- •Is currently using certain skin products and is uninterested in stopping use of the products during the study
- •Pregnant or breastfeeding
研究组 & 干预措施
1
2% chlorhexidine gluconate impregnated cloths, self applied three times weekly
干预措施: 2% chlorhexidine gluconate (CHG) impregnated cloths (Drug)
2
Comfort Bath cloths, self applied three times weekly
干预措施: Comfort Bath cloths (placebo cloths) (Drug)
结局指标
主要结局
The rate of skin and soft tissue infections among platoons enrolled in OCS.
时间窗: May - Nov 2007
次要结局
- The rate of new S. aureus colonization of the nares and axilla among platoons enrolled in OCS.(May- Nov 2007)