Trial of 2% Chlorhexidine Bathing on Nosocomial Infections in the Surgical Intensive Care Unit
Randomized Controlled Trial of 2% Chlorhexidine Bathing on Nosocomial Infections in the Surgical Intensive Care Unit
研究概览
详细说明
Upon study enrollment, patients will be randomized to one of two study arms. Patients in study arm one will receive standard bathing (soap and water or non-medicated cloth) daily. Patients in study arm two will receive a 2% chlorhexidine bath on study day 1 and every 48 hours and a standard bath (soap and water or non-medicated cloths) on study day 2 and every 48 hours. Patients will be followed until ICU day 28 or discharged from the surgical ICU.
Hypothesis: Compared to standard daily bathing, chlorhexidine-based bathing on ICU admission and every 48 hours will decrease the incidence of nosocomial infections.
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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Texas
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Houston、Texas、美国、77030
- Surgical Intensive Care Unit, The Methodist Hospital
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Admission to the surgical intensive care unit at The Methodist Hospital (Houston, TX)
- Anticipated surgical intensive care unit length of stay of 48 hours or more
Exclusion Criteria:
- Pregnancy
- Age less than 18 years old
- Braden score of less than 9 upon admission to the surgical intensive care unit
- Known allergy to chlorhexidine gluconate
- Active skin irritation upon admission to the surgical intensive care unit
学习计划
研究是如何设计的？
设计细节
- 主要用途：预防
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
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有源比较器：Chlorhexidine gluconate bathing
Upon study enrollment, patients will be bathed with a 2% chlorhexidine gluconate solution on study day 1 and every 48 hours until study completion.
The patient will be bathed using standard bathing (non-medicated cloths or soap and water) on study day 2 and every 48 hours after that.
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Chlorhexidine gluconate 2% solution applied topically for full body bathing once every 48 hours
其他名称：
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安慰剂比较：Standard bathing
Upon study enrollment, patients will be bathed using standard bathing (non-medicated cloths or soap and water) daily.
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The patient will be bathed using standard bathing (non-medicated cloths or soap and water) daily.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
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Incidence of Nosocomial Infection
大体时间：Up to 28 days
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Proportion of patients with one or more incident nosocomial infections. Primary Efficacy Endpoints* (Composite of new nosocomial infection)
(*)Diagnosed using the Centers for Disease Control criteria for hospital acquired infections. Only infections that develop 48 hours or more after study enrollment will be counted as primary endpoints. (**)Ventilator associated pneumonia is defined as pneumonia that developed after 48 hours of mechanical ventilation. |
Up to 28 days
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Incidence of Skin Irritation
大体时间：up to 28 days
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The incidence of new onset skin irritation will be recorded and graded for severity using the National Cancer Institute Common Terminology Criteria for Adverse Events v4.03.
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up to 28 days
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ICU Length of Stay in Days
大体时间：up to 28 days
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Number of days in the ICU after enrollment in study until first ICU discharge.
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up to 28 days
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Number of Patients With In-hospital Mortality
大体时间：up to 28 days or until first hospital discharge
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up to 28 days or until first hospital discharge
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合作者和调查者
赞助
调查人员
- 首席研究员：Joshua T Swan, Pharm.D.、The Methodist Hospital, Texas Southern University
出版物和有用的链接
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
关键字
其他相关的 MeSH 术语
其他研究编号
- Pro00006876
- 1211-0239 (其他标识符：HMRI IRB)
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
IPD 计划说明
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Chlorhexidine gluconate的临床试验
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University of British ColumbiaCanadian Foundation for Dental Hygiene Research and Education; British Columbia Dental Hygienists...完全的