Staphylococcus Aureus Surgical Site Infection Multinational Epidemiology in Europe
- Conditions
- Wound Infection, SurgicalStaphylococcus AureusEpidemiology
- Registration Number
- NCT03353532
- Lead Sponsor
- University of Cologne
- Brief 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 178902
- Age ≥18 years at the time of surgery
- Cases with missing data defined as "missing completely at random" (MCAR)
- Infection at the time of surgery
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To determine procedure specific incidence of Staphylococcus aureus surgical site infections in Europe 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 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.
- Secondary Outcome Measures
Name Time Method To determine the overall outcomes of Staphylococcus aureus surgical site infections in Europe 30 days from surgical procedure The Outcome will be assessed within the case-control part and achieved by comparison of Overall Outcome of cases and controls
To determine the procedure specific outcomes of Staphylococcus aureus surgical site infections in Europe 30 days from surgical procedure The Outcome will be assessed within the case-control part and achieved by comparison of procedure specific Outcome of cases and controls
To determine the overall economic burden of Staphylococcus aureus surgical site infections in Europe 30 days from surgical procedure The economic burden will be assessed within the case-control part and achieved by comparison of Overall economic burden (i.e. ICU Treatment, hemodialysis and mechanical Ventilation) of cases and controls
To determine the procedure specific economic burden of Staphylococcus aureus surgical site infections in Europe 30 days from surgical procedure The economic burden will be assessed within the case-control part and achieved by comparison of procedure specific economic burden (i.e. ICU Treatment, hemodialysis and mechanical Ventilation) of cases and controls
Trial Locations
- Locations (14)
Manchester University NHS Foundation Trust (MFT)
🇬🇧Manchester, United Kingdom
Centre Hospitalier Départemental Vendee
🇫🇷La Roche-sur-Yon, France
Centre Hospitalier et Universitaire de Limoges
🇫🇷Limoges, France
University Hospital Cologne
🇩🇪Cologne, NRW, Germany
Centre Hospitalier Régional et Universitaire de Tours
🇫🇷Tours, France
University Hospital Bonn
🇩🇪Bonn, Germany
Jena University Hospital
🇩🇪Jena, Germany
Hospital of the University of Munich
🇩🇪Munich, Germany
University of Udine and Azienda Sanitaria Universitaria Integrata
🇮🇹Udine, Italy
Hospital General Universitario Gregorio Marañón e Instituto de Investigación Sanitaria Gregorio Marañón
🇪🇸Madrid, Spain
Institut Hospital del Mar d'Investigacions Mèdiques
🇪🇸Barcelona, Spain
Hospital Clínic Barcelona
🇪🇸Barcelona, Spain
Hospital Universitari i Politècnic La Fe
🇪🇸Valencia, Spain
Hospital Universitario Ramón y Cajal
🇪🇸Madrid, Spain