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临床试验/NCT02484287
NCT02484287终止不适用

Quality Control: A Prospective Analysis of External Ventricular Drain (EVD) Effectiveness

University of Oklahoma1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2016年4月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
终止
入组人数
60
试验地点
1
主要终点
Infection Rates of EVD Patients

研究概览

简要总结

The purpose and/or hypothesis: To decrease the amount of external ventricular drain (EVD) related catheter infections by comparing the efficacy of Oklahoma University Medicine standard EVD catheters, both impregnated and non-impregnated, in three principle areas: incidence of infection, cost analysis, and average durations of placement, all while maintaining the standards of technique.

详细描述

Experimental design: Track external ventricular drain (EVD) associated infections and through quality prospective analysis and compare the usage of standard catheters used by the department here at Oklahoma University, 1) the 35cm Codman Bactiseal rifampin and clindamycin impregnated catheter, 2) the Ventriclear EVD Antibiotic Catheter, and 3) the 36 cm Integra Hermatic large style ventricular catheter, in terms of incidence of infections, cost, duration of placement, and differences in placement technique.

Proposed procedure: Monitor for infections associated with and related to EVD placement in patients and assess if infections rates are affected by usage of antibiotic impregnated EVD catheters.

Importance of knowledge reasonably expected to result from the research: While use of sterile techniques and periprocedural antibiotics have traditionally been used to combat infection, infection rates remain above goal leading to the question of whether the antibiotic impregnated catheter should be added to the standard of care. With the knowledge gained, the investigators hope to decrease the amount of external ventricular drain related catheter infections and reduce use of prolonged antibiotics.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Other
盲法
Triple (Participant, Care Provider, Investigator)

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Patients who require placement of external ventricular drain.

排除标准

  • •Prisoners and/or those who may be pregnant.

研究组 & 干预措施

Integra External Drainage Catheter

Active Comparator

The Integra External Drainage Catheter non antibiotic-impregnated EVD catheter

干预措施: The Integra External Drainage Catheter. (Device)

Ventriclear EVD Antibiotic Catheter

Active Comparator

The Ventriclear EVD Antibiotic Catheter antibiotic-impregnated EVD catheter

干预措施: The Ventriclear EVD Antibiotic Catheter (Device)

Codman Bactiseal EVD Catheter Set

Active Comparator

The Codman Bactiseal EVD Catheter Set antibiotic-impregnated EVD catheter

干预措施: The Codman Bactiseal EVD Catheter Set (Device)

结局指标

主要结局

Infection Rates of EVD Patients

时间窗: 24 months

Infection rates of EVD patients

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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