Staphylococcus Aureus Surgical Site Infection Multinational Epidemiology in Europe
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 178,902
- 试验地点
- 14
- 主要终点
- To determine procedure specific incidence of Staphylococcus aureus surgical site infections in Europe
研究概览
简要总结
This is a retrospective multinational, multicenter cohort study with a nested case-control. The study includes all surgical procedures performed at a participating site to prevent bias.
Data will be assessed in two populations.
Cohort population: Export of electronic file data on demographics, surgical procedure ICPM code, duration of procedure, American Society of Anesthesiologists (ASA) score, body mass index, comorbidity ICD codes, and wound class of all patients undergoing surgery.
Nested case-control population: For patients establishing S. aureus SSI and 1:1 matched controls from the same center further data will be captured: Length of hospitalization, length of ICU stay and reason as well as attribution to SSI, survival at 30 and at 90 days, antibiotic treatments including duration, functional status at admission and at final discharge; necessity for surgical revision, and death attributed to SSI.
If readmission is necessary, reason and attribution to SSI, length of hospitalization and length of ICU stay as well as all antibiotic treatments and their duration will be recorded.
The cases causative pathogens including resistance patterns and type of SSI according to CDC criteria will be captured.
Matching criteria comprise the following:
- Type of procedure
- Age
- ASA score
- BMI
- Duration of procedure (as percentile for this procedure)
- Diabetes
- Sex
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Retrospective
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
- •Age ≥18 years at the time of surgery
排除标准
- •Cases with missing data defined as "missing completely at random" (MCAR)
- •Infection at the time of surgery
结局指标
主要结局
To determine procedure specific incidence of Staphylococcus aureus surgical site infections in Europe
时间窗: 30 days from surgical procedure
Surgical site infections will be determined within the cohort of all patients that underwent surgery within 1 year at all participating sites. A subgroup Analysis will reveal procedure specific incidence.
To determine overall incidence of Staphylococcus aureus surgical site infections in Europe
时间窗: 30 days from surgical procedure
Surgical site infections will be determined within the cohort of all patients that underwent surgery within 1 year at all participating sites.
次要结局
- To determine the overall outcomes of Staphylococcus aureus surgical site infections in Europe(30 days from surgical procedure)
- To determine the procedure specific outcomes of Staphylococcus aureus surgical site infections in Europe(30 days from surgical procedure)
- To determine the overall economic burden of Staphylococcus aureus surgical site infections in Europe(30 days from surgical procedure)
- To determine the procedure specific economic burden of Staphylococcus aureus surgical site infections in Europe(30 days from surgical procedure)
研究者
Oliver Cornely, MD
Prof. Dr.
University of Cologne
