Skip to content

Staphylococcus Aureus Surgical Site Infection Multinational Epidemiology in Europe

Staphylococcus Aureus Surgical Site Infection Multinational Epidemiology in Europe

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03353532
Acronym
SALT
Enrollment
178902
Registered
2017-11-27
Start date
2017-08-01
Completion date
2021-01-31
Last updated
2021-05-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Epidemiology, Staphylococcus Aureus, Wound Infection, Surgical

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

Interventions

None listed

Sponsors

Pfizer
CollaboratorINDUSTRY
University of Cologne
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum

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

Design outcomes

Primary

MeasureTime frameDescription
To determine overall incidence of Staphylococcus aureus surgical site infections in Europe30 days from surgical procedureSurgical site infections will be determined within the cohort of all patients that underwent surgery within 1 year at all participating sites.
To determine procedure specific incidence of Staphylococcus aureus surgical site infections in Europe30 days from surgical procedureSurgical 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.

Secondary

MeasureTime frameDescription
To determine the procedure specific outcomes of Staphylococcus aureus surgical site infections in Europe30 days from surgical procedureThe 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 outcomes of Staphylococcus aureus surgical site infections in Europe30 days from surgical procedureThe Outcome will be assessed within the case-control part and achieved by comparison of Overall Outcome of cases and controls
To determine the overall economic burden of Staphylococcus aureus surgical site infections in Europe30 days from surgical procedureThe 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 Europe30 days from surgical procedureThe 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

Other

MeasureTime frameDescription
To estimate the number of patients at risk for Staphylococcus aureus surgical site infection30 days from surgical procedureThis will be extrapolated from epidemiologcal data assessed within the cohort
To characterize the composition of the surgical patient population in Europe30 days from surgical procedureThe composition of the surgical patient population in Europe will be performed by subgroup Analysis of the cohort
To estimate the economic burden, including direct treatment and indirect costs, imposed by Staphylococcus aureus surgical site infections in Europe30 days from surgical procedureDirect and indirect Treatment costs will be assessed within the case-control part. Cases and controls will be compared regarding costs.

Countries

France, Germany, Italy, Spain, United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 24, 2026