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NCT Number: NCT03353532

Staphylococcus Aureus Surgical Site Infection Multinational Epidemiology in Europe

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

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Key information

Conditions

Staphylococcus Aureus Bacterial Infections Bacterial Infections and Mycoses Epidemiology Gram-Positive Bacterial Infections Infections Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Staphylococcal Infections Surgical Wound Infection Wound Infection Wound Infection, Surgical

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Centre Hospitalier Départemental Vendee, La Roche-sur-Yon, France

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Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. To determine overall incidence of Staphylococcus aureus surgical site infections in Europe

    Time frame: 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.

  2. To determine procedure specific incidence of Staphylococcus aureus surgical site infections in Europe

    Time frame: 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.

Secondary outcomes

  1. To determine the overall outcomes of Staphylococcus aureus surgical site infections in Europe

    Time frame: 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

  2. To determine the procedure specific outcomes of Staphylococcus aureus surgical site infections in Europe

    Time frame: 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

  3. To determine the overall economic burden of Staphylococcus aureus surgical site infections in Europe

    Time frame: 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

  4. To determine the procedure specific economic burden of Staphylococcus aureus surgical site infections in Europe

    Time frame: 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

Other outcomes

  1. To characterize the composition of the surgical patient population in Europe

    Time frame: 30 days from surgical procedure

    The composition of the surgical patient population in Europe will be performed by subgroup Analysis of the cohort

  2. To estimate the number of patients at risk for Staphylococcus aureus surgical site infection

    Time frame: 30 days from surgical procedure

    This will be extrapolated from epidemiologcal data assessed within the cohort

  3. To estimate the economic burden, including direct treatment and indirect costs, imposed by Staphylococcus aureus surgical site infections in Europe

    Time frame: 30 days from surgical procedure

    Direct and indirect Treatment costs will be assessed within the case-control part. Cases and controls will be compared regarding costs.

Sponsors and collaborators

Lead sponsor

University of Cologne

Other

Collaborators

  • Pfizer

Registry information

Acronym: SALT

Important dates

Study start
2017
Primary completion
2021
Study completion
2021
First posted
Nov 27, 2017
Registry last updated
May 24, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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