跳至主要内容
临床试验/NCT03353532
NCT03353532已完成不适用

Staphylococcus Aureus Surgical Site Infection Multinational Epidemiology in Europe

University of Cologne14 个研究点 分布在 5 个国家目标入组 178,902 人开始时间: 2017年8月1日最近更新:
适应症

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

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Oliver Cornely, MD

Prof. Dr.

University of Cologne

研究点 (14)

Loading locations...

相似试验