NCT03353532

Staphylococcus Aureus Surgical Site Infection Multinational Epidemiology in Europe

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 178,902 (actual)
• Sponsor: University of Cologne · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: —

Summary

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

Conditions

• Staphylococcus Aureus
• Wound Infection, Surgical
• Epidemiology

Timeline

• Start date: 2017-08-01
• Primary completion: 2021-01-01
• Completion: 2021-01-31
• First posted: 2017-11-27
• Last updated: 2021-05-24

Locations

14 sites across 5 countries: France, Germany, Italy, Spain, United Kingdom