Polyvinylpyrrolidone (PVP) Iodine vs Chlorhexidine in Alcohol for Disinfection of the Surgical Site: a Cluster-randomized Multicenter Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 3,321
- 试验地点
- 3
- 主要终点
- Surgical site infections (SSIs)
研究概览
简要总结
Prospective cluster-randomized multicenter cross-over trial to prove non-inferiority of PI compared to CHX in preoperative skin antisepsis
详细描述
Surgical site infections (SSIs) are the most common nosocomial infections in surgical patients causing significant increases in morbidity, mortality, and health care costs. As they are usually caused by components of the normal skin flora, disinfection of the surgical site with an antiseptic skin preparation is standard practice prior to any surgical intervention. The most commonly used disinfectants are either chlorhexidine in alcoholic solution (CHX) or PVP iodine in alcoholic solution (PI) This prospective cluster-randomized multicenter cross-over trial is to prove non-inferiority of PI compared to CHX in preoperative skin antisepsis in abdominal and cardiothoracic surgery in regard of SSIs.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 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
- •undergoing cardiac or certain types of abdominal surgery (colorectal surgery, cholecystectomy, herniotomy, appendectomy and bariatric surgery) which are routinely followed up by the study Centers during the study period
排除标准
- •contraindication to the use of either one of the compounds ( CHX: intolerance to any of the compounds of the preparation, application on cornea, wounds or mucosal Membrane. PI: hyperthyroid disease, intolerance to any of the compounds, iodine allergy, 2 weeks prior to radio- iodine treatment, Dermatitis herpetiformis Duhring, application on cornea, wounds or mucosal membranes)
- •Emergency surgical Intervention
- •Patients refusing General consent for use of personal data
研究组 & 干预措施
Cardiothoracic surgery - PI disinfection
干预措施: PI Disinfection (Drug)
Cardiothoracic surgery - CHX disinfection
干预措施: CHX disinfection (Drug)
Abdominal surgery - PI disinfection
干预措施: PI Disinfection (Drug)
Abdominal surgery - CHX disinfection
干预措施: CHX disinfection (Drug)
结局指标
主要结局
Surgical site infections (SSIs)
时间窗: occurrence of surgical site infections is evaluated at three time points: at time of dismissal from the hospital (approx. 1 week after surgical intervention); 30 days after abdominal and cardiac surgery; 1 year for cardiac surgery
Comparison of SSI rates between the two groups using standard chi-square test. Presence of SSIs for abdominal and cardiac surgeries as defined by Swiss society of hospital epidemiologists (Swissnoso) according to National Healthcare Safety Network (NHSN) criteria. Analysis will be performed using the final SSI rate (30 days for abdominal, 30 days/1 year for cardiac surgery) and according to the different types of infections. Infection ratio will be calculated as crude ratio as well as adapted to the National Nosocomial Infections Surveillance System (NNIS) score. The method of aggregation for the combined SSI rate for both types of surgery together will be a weighted average based on the proportion of SSIs from each surgery type. The measure includes no scale.
次要结局
- American Society of Anesthesiologists (ASA) -score(day of surgery)
- Body Mass Index (BMI)(day of surgery)
- Mortality(in-hospital (approx. 1 week from surgical intervention) and 30 day for abdominal surgery; in-hospital (approx. 1 week from surgical intervention), 30 day and 365 day for cardiac surgery)
- Change in creatinine (ymol/l)(in- hospital stay (approx. 1 week from surgical intervention))
- National Nosocomial Infections Surveillance System (NNIS) index(in- hospital stay (approx. 1 week from surgical intervention))
- Change in leukocytes (x10^9/l)(in- hospital stay (approx. 1 week from surgical intervention))
- Change in hemoglobin (g/l)(day of surgery)
- Timing of antimicrobial prophylaxis(day of surgery)
- Type of SSI: superficial, deep, organ-space(three time points: at time of dismissal from the hospital (approx. 1 week after surgical intervention); 30 days after abdominal and cardiac surgery; 1 year for cardiac surgery)
- Duration of surgery(time from start to stop of surgical intervention)
- Wound contamination -class according to Centers for Disease Control and Prevention(CDC)(three time points: at time of dismissal from the hospital (approx. 1 week after surgical intervention); 30 days after abdominal and cardiac surgery; 1 year for cardiac surgery)
- Change in concentration for C reactive Protein (CRP) (mg/l)(in- hospital stay (approx. 1 week from surgical intervention))