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Staphylococcus Aureus Surgical Site Infection Multinational Epidemiology in Europe

NCT03353532 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 178902

Last updated 2021-05-24

No results posted yet for this study

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

Sponsors & Collaborators

  • Pfizer

    collaborator INDUSTRY

  • University of Cologne

    lead OTHER

Principal Investigators

  • Oliver A Cornely, MD · University of Cologne

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-08-01
Primary Completion
2021-01-01
Completion
2021-01-31

Countries

  • France
  • Germany
  • Italy
  • Spain
  • United Kingdom

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03353532 on ClinicalTrials.gov