Impact of the Use of Three Dressings in the Prevention of Surgical Wound Infection in Patients Undergoing Mayor Cardiac Surgery: a Clinical Prospective and Randomized Study
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 900
- 主要终点
- prevention of surgical wound infection
研究概览
简要总结
To compare cost effectiveness of a polyurethane dressing or a vacuum therapy dressing versus the conventional gauze in the prevention of superficial wound infection y major cardiac surgery
详细描述
It is a clinical prospective and randomized study. patientes will be randomized to three groups on the day of surgery: conventional gauze, polyurethane or vacuum therapy dressing. Clinical al microbiological data will be monitorized to evaluate the infection rate of surgical wound , mediastinitis, days of hospital stay and consumption of antimicrobials.
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
- None
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
- •patient scheduled to cardiac surgery.
- •signed informed consent form
排除标准
- •hypersensibility to dressings
研究组 & 干预措施
conventional gauze
Device is a conventional gauze and the change will be to the day 2 and 4 of surgery
干预措施: dressing MEPORE (Device)
polyurethane dressing
Device is a polyurethane dressing and the change will be to the day 7 of surgery
干预措施: dressing MEPILEX (Device)
vacuum therapy dressing
Device is a vacuum therapy dressing and the change will be to the day 7 of surgery
干预措施: dressing PICCO (Device)
结局指标
主要结局
prevention of surgical wound infection
时间窗: surgery date up to 6 months
surgical wound infection measured as number of patients suffering surgical wound infection during the study period
次要结局
- hospital stay(from hospitalization until an average of 1 year)
- dressing consumption cost(from surgery date until an average of 8 weeks)
- antimicrobial consumption(from surgery date until an average of 1 year)
研究者
Maria Jesus Perez
Principal Investigator
Hospital General Universitario Gregorio Marañon