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临床试验/NCT01955226
NCT01955226终止不适用

Unit Based Comparison of Non- Versus Chlorhexidine-Impregnated Central Line Dressings

Yale University2 个研究点 分布在 1 个国家目标入组 16 人开始时间: 2014年2月最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
16
试验地点
2
主要终点
Reduction in unscheduled central catheter dressing changes

研究概览

简要总结

The purpose of this study is to determine whether Tegaderm CHG clear dressing reduces the number of unscheduled central catheter dressing changes compared to standard clear Tegaderm IV dressing in pediatric patients between the ages of 2 months to 18 years with central venous access. Secondarily, we will monitor contact skin irritation and central line associated blood stream infections.

详细描述

In this prospective, randomized, cohort study, we plan on enrolling all patients 2 months to 18 years of age admitted with a central venous catheter expected to be in place for > 48 hours. Patients will be randomized to either receive 1) Tegaderm CHG clear dressing or 2) standard clear Tegaderm IV dressing. All central line care will remain uniform between the two groups as dictated by the central line maintenance bundle currently directing central line care in our children's hospital. Study completion will occur at the time of central line removal or discharge from the hospital, whichever comes first.

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
Single (Outcomes Assessor)

入排标准

年龄范围
2 Months 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • All patients 2 months to 18 years of age admitted with a central venous catheter expected to be in place for > 48 hours.

排除标准

  • Patients with known allergies to chlorhexidine or Tegaderm and those previously enrolled in this study will be excluded.
  • Patients with portacatheters

结局指标

主要结局

Reduction in unscheduled central catheter dressing changes

时间窗: Study completion (Study completion will occur at the time of central line removal or discharge from the hospital, whichever comes first). On average 2 weeks.

The policy at our institution is to change central catheter dressings every 7 days unless they are soiled or detached. We will document dressing changes for the duration of line use and document the reason for the dressing change.

次要结局

  • Blood Stream Infection(Discharge (at 2 weeks or more))
  • Skin irritation(Study completion (Study completion will occur at the time of central line removal or discharge from the hospital, whichever comes first). On average 2 weeks.)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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