NCT00389558已完成4 期
Comparison of Amukin Versus Biseptine Use for Dressing Application of Epicutaneocavous Catheters for Nosocomial Infection Prevention
Maternite Regionale Universitaire2 个研究点 分布在 1 个国家目标入组 453 人开始时间: 2006年9月1日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 453
- 试验地点
- 2
- 主要终点
- Efficacy on skin colonization of two commercially available antiseptics
研究概览
简要总结
The purposes of the study are:
- To compare the local efficacy (skin colonization) of 2 commercialized antiseptics used for the disinfection of the dressing application for an epicutaneocavous catheter (EPI).
- To evaluate whether the bacteria responsible for nosocomial infection is comparable to the flora diagnosed at the EPI site.
详细描述
Epicutaneocavous catheter is a significant risk factor for nosocomial infection in newborn infants. These infections have been related to local bacterial colonisation. Therefore thorough disinfection should lower the risk of nosocomial infection. However, the local efficacy of antiseptic use has not yet been clearly evaluated in this situation.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- — 至 3 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All infants admitted to the Neonatal Intensive Care Unit
- •Epicutaneocavous catheter insertion indication
排除标准
- •Epicutaneocavous catheter not inserted within the Unit
结局指标
主要结局
Efficacy on skin colonization of two commercially available antiseptics
时间窗: 2 weeks
次要结局
- In case of nosocomial infection, relationship with skin bacteria(2 weeks)
研究者
研究点 (2)
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