Clinical Assessment of a New Catheter Surface Coating With Antimicrobial Properties: Efficacy and Effect of Intensive Catheter and Exit Site Care Education
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 90
- 试验地点
- 2
- 主要终点
- Bacterial colonisation of the catheter surface
研究概览
简要总结
The study investigates the efficacy of a catheter with antibacterial surface coating in preventing central venous catheter related infection and the effect of an intensive hygiene and catheter care education of the nursing staff on preventing central venous catheter-related infection.
详细描述
The risk of catheter-related bloodstream infection depends on catheter type, method and site of insertion, aseptic technique and number of manipulations. To address this problem, efforts have focused on engineering biomaterials and surfaces with antibacterial properties to prevent bacteria adhesion and biofilm formation.
In view of the necessity to reduce catheter-related bloodstream infections and of the inadequacy of currently available antimicrobially coated devices, a new antimicrobial catheter surface was developed.
Among other factors, the mode and quality of catheter handling and care of exit site is an important aspect with respect to catheter-related infections.
The clinical study aims at providing data on antimicrobial efficiency of the 2 types of CE certified double lumen catheters and a supposed additional preventive effect of intense hygiene training on catheter-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
- Triple (Participant, Care Provider, Investigator)
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
- •central venous catheter placement
- •Need for extracorporeal renal replacement therapy (acute and chronic renal failure)
- •Age over 18 years
- •Written informed consent
- •Needed catheter length 15 cm or 20 cm
排除标准
- •Known infectivity with Hepatitis B Virus (HBV)/Hepatitis C Virus (HCV)/Human Immunodeficiency Virus (HIV)
- •Any infection associated with one or more positive blood cultures within 10 days prior to catheter implantation
- •Bacteremia with a former catheter within 10 days prior to catheter implantation
- •Known pregnancy
- •Lactation
- •Participation in another clinical study during the preceding 30 days
结局指标
主要结局
Bacterial colonisation of the catheter surface
时间窗: at explantation
次要结局
- Blood parameters(during dialysis)
- Catheter survival(at explantation)
- Surface deposits of thrombogenic activity(at explantation)
- Exit site appearance(at routine catheter care)