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临床试验/NCT07001527
NCT07001527已完成3 期

Dressing Impregnated With Chlorhexidine and Vancomycin for the Prophylaxis of Central Venous Catheter-related Infections - a Randomized Trial

Hospital Universitario Evangelico de Curitiba1 个研究点 分布在 1 个国家目标入组 516 人开始时间: 2022年6月1日最近更新:
适应症
干预措施

试验速览

阶段
3 期
状态
已完成
发起方
入组人数
516
试验地点
1
主要终点
Infection

研究概览

简要总结

You are being invited as a volunteer to participate in the study "Dressing impregnated with chlorhexidine and vancomycin for the prophylaxis of central venous catheter-related infections." The objective is to evaluate the incidence of bloodstream infection related to the catheter in ICU patients with central venous catheters (CVC), using dressings impregnated or not with chlorhexidine/vancomycin. We believe this study is important as it aims to evaluate a new dressing method intended to reduce bloodstream-related infections.

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, Care Provider)

入排标准

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

入选标准

  • •IInclusion criteria included: age over 18 years, admitted to the ICU, need for a CVC placed in the ICU by the trained team, use of the CVC for a period exceeding 72 hours, and intact skin in the area of contact with the dressing. CVC inserted outside the ICU and need for two CVCs in the same patient simultaneously were

排除标准

  • •. A subsequent CVC could not be randomized. Other infections were not excluded during the evaluation. Only short-term CVC were evaluated (long-term and hemodialysis were excluded).

研究组 & 干预措施

Control

Placebo Comparator

COmmon dressing

干预措施: Chlorhexidine (Device)

Impregnated

Active Comparator

Impregnated

干预措施: Chlorhexidine (Device)

结局指标

主要结局

Infection

时间窗: 30 days

CRBSI was the primary endpoint

次要结局

未报告次要终点

研究者

发起方
Hospital Universitario Evangelico de Curitiba
申办方类型
Other
责任方
Principal Investigator
主要研究者

Felipe Francisco Bondan Tuon

Professor

Pontifícia Universidade Católica do Paraná

研究点 (1)

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