Evaluation of Safety and Performance of the BIP Central Venous Catheter With Anti-infective Coating
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 2
- 主要终点
- Assessment of safety by evaluation of CVC related adverse events and any problems in post operative course.
研究概览
简要总结
The primary objective of this trial was to determine Bactiguard coated BIP CVC's safety and performance and compare it to corresponding standard uncoated CVC.
详细描述
The primary objective of this study is to determine the safety for the medical device of 'BIP central venous catheter". Safety is assessed by evaluation of adverse events (according to ISO 14155:2011). Examples of CVC related common events are phlebitis, infection at the infection site, catheter related bacteremia/fungemia, septicemia, sepsis, thrombosis, lung emboli and pneumothorax.
The secondary objective is to assess the overall performance by evaluating if there were any CVC handling problems experienced by the physician/health care personnel.
Furthermore, an exploratory objective of this study is to assess coating and microbial colonization.
Included in the study were men and women aged 18 years or older undergoing elective standardized large surgery with a planned CVC catheterization in right or left jugular vein or subclavian vein planned for at least 3 days.
This study is a single-centre, randomized, single-blind, controlled study of tolerability and safety of BIP CVC with noble metal alloy coating.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
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
- •Adult men and women ≥ 18 years of age
- •Were, in the opinion of the investigator, able to communicate with and understand the trial personnel and comply with the requirements of the trial
- •Requiring CVC catheterization for venous access, via right (most often) or left jugular vein or subclavian vein, during and after elective large surgery (liver or pancreas resection or intestinal/bowel surgery) planned for at least 3 days
- •Had signed the informed consent
排除标准
- •Known transmissive blood disease
- •Known multiresistant bacterial colonization
- •Ongoing infection
- •Thromboembolism
- •Anti-coagulation treatment excluding prophylaxis
- •CVC during last 2 months
- •History of problems with CVC
- •Pregnancy
结局指标
主要结局
Assessment of safety by evaluation of CVC related adverse events and any problems in post operative course.
时间窗: Through study completion, an average of 10 days
Overall assessment of safety by evaluation of CVC related adverse events and any problems in post operative course.
次要结局
- Assessment of the overall performance(Through study completion, an average of 10 days)