Staphylococcus Aureus Surgical Site Infection Multinational Epidemiology in Europe

Study Overview
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Brief Summary
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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

Official Title
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Staphylococcus Aureus Surgical Site Infection Multinational Epidemiology in Europe

Conditions
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Staphylococcus Aureus, Wound Infection, Surgical, Epidemiology

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥18 years at the time of surgery Exclusion Criteria: Cases with missing data defined as missing completely at random (MCAR) Infection at the time of surgery

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Cohort<br>Adult patients with SSI after any surgical procedure. | |
| Case-Control<br>Cases: Patients establishing S. aureus SSI Controls: Patients from the same center who did not undergo S. aureus SSI, matched by the following criteria Type of procedure Age ASA score BMI Duration of procedure (as percentile for this procedure) Diabetes Sex | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine overall incidence of Staphylococcus aureus surgical site infections in Europe | Surgical site infections will be determined within the cohort of all patients that underwent surgery within 1 year at all participating sites. | 30 days from surgical procedure | 
| To determine procedure specific incidence of Staphylococcus aureus surgical site infections in Europe | 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. | 30 days from surgical procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine the overall outcomes of Staphylococcus aureus surgical site infections in Europe | The Outcome will be assessed within the case-control part and achieved by comparison of Overall Outcome of cases and controls | 30 days from surgical procedure | 
| To determine the procedure specific outcomes of Staphylococcus aureus surgical site infections in Europe | The Outcome will be assessed within the case-control part and achieved by comparison of procedure specific Outcome of cases and controls | 30 days from surgical procedure | 
| To determine the overall economic burden of Staphylococcus aureus surgical site infections in Europe | 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 | 30 days from surgical procedure | 
| To determine the procedure specific economic burden of Staphylococcus aureus surgical site infections in Europe | 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 | 30 days from surgical procedure |