Impact of Medixair® System on Surgical Site Infection in Patients Admitted Into the Postoperative Cardiac Intensive Care Unit
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,000
- 主要终点
- Infection rates after cardiac surgery
研究概览
简要总结
There is a growing incidence of sepsis and septic shock in people after surgery, for which there may be several reasons: more elderly people and more severe illnesses are entering operating theatres, more invasive systems are being used to take care of patients in intensive care units, etc... Sepsis and septic shock are the most prevalent illnesses which cause the highest mortality in intensive care units.
The incidence of this illness is 500,000 / year in the USA, and 240-400 / 100,000 persons in Europe. So this is a subject of great interest in hospitals and also to the National Health System (to both health workers and the health authorities) as a lot of money is spent on this illness.
Since the 19th century, ultraviolet rays have been known to be able to sterilize microorganisms (to kill them); yet no ultraviolet system machine has been on the market, until now, to control nosocomial infections.
The Medixair system, which aims to do this, has recently come on to the market. It uses C-ultraviolet rays, which are the strongest kind of ultraviolet rays to kill microorganisms.
Thus, it is of interest to know whether this system is good enough to lower infections in intensive care units. It is logical to believe that the the fewer the micro-organisms, the lower the possibilities of infection.
详细描述
Study design Prospective, comparative, randomized, non intervention study
Patients
Patients older than 18 years
Cardiac Surgery anesthetized using Extracorporeal Circulation
Randomization
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
- None
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients admitted to Postoperative Cardiac Intensive Care Unit after Cardiac Surgery with Extracorporeal Circulation
排除标准
- •Not signing informed consent
结局指标
主要结局
Infection rates after cardiac surgery
时间窗: 3 weeks
To assess if there are fewer catheter infections, less bacteraemia, fewer urinary infections, fewer surgery site infections, fewer pneumonias in patients who have spent their first days after a heart surgery in a box with the Medixair system than without it.
次要结局
- mortality rate(3 weeks and for the whole stay at hospital)
- Number of infected patients(3 weeks)
- number of patients with pneumonia(3 weeks)
研究者
F. Javier Alvarez
Professor
University of Valladolid