Staphylococcus Aureus Surgical Site Infection Multinational Epidemiology in Europe (SALT)

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

Study Overview

• Status: Completed
• Conditions: Staphylococcus Aureus; Wound Infection, Surgical; Epidemiology

• Study Type: Observational
• Enrollment (Actual): 178902

Contacts and Locations

Study Locations

• France
  • La Roche-sur-Yon, France
    • Centre Hospitalier Départemental VENDEE
  • Limoges, France
    • Centre Hospitalier et Universitaire de Limoges
  • Tours, France
    • Centre Hospitalier Régional et Universitaire de Tours
• Germany
  • Bonn, Germany
    • University Hospital Bonn
  • Jena, Germany
    • Jena University Hospital
  • Munich, Germany
    • Hospital of the University of Munich
  • NRW
    • Cologne, NRW, Germany, 50937
      • University Hospital Cologne
• Italy
  • Udine, Italy
    • University of Udine and Azienda Sanitaria Universitaria Integrata
• Spain
  • Barcelona, Spain
    • Hospital Clinic Barcelona
  • Barcelona, Spain
    • Institut Hospital del Mar d'Investigacions Mèdiques
  • Madrid, Spain
    • Hospital Universitario Ramon Y Cajal
  • Madrid, Spain
    • Hospital General Universitario Gregorio Marañón e Instituto de Investigación Sanitaria Gregorio Marañón
  • Valencia, Spain
    • Hospital Universitari I Politecnic La Fe
• United Kingdom
  • Manchester, United Kingdom
    • Manchester University NHS Foundation Trust (MFT)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Adult patients with SSI after any surgical procedure

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Cohort; Adult patients with SSI after any surgical procedure.
Case-Control; 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?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
To characterize the composition of the surgical patient population in Europe	The composition of the surgical patient population in Europe will be performed by subgroup Analysis of the cohort	30 days from surgical procedure
To estimate the number of patients at risk for Staphylococcus aureus surgical site infection	This will be extrapolated from epidemiologcal data assessed within the cohort	30 days from surgical procedure
To estimate the economic burden, including direct treatment and indirect costs, imposed by Staphylococcus aureus surgical site infections in Europe	Direct and indirect Treatment costs will be assessed within the case-control part. Cases and controls will be compared regarding costs.	30 days from surgical procedure

Collaborators and Investigators

• Sponsor: University of Cologne
• Collaborators: Pfizer

Publications and helpful links

General Publications

• Mellinghoff SC, Bruns C, Al-Monajjed R, Cornely FB, Grosheva M, Hampl JA, Jakob C, Koehler FC, Lechmann M, Maged B, Otto-Lambertz C, Rongisch R, Rutz J, Salmanton-Garcia J, Schlachtenberger G, Stemler J, Vehreschild J, Wulfing S, Cornely OA, Liss BJ. Harmonized procedure coding system for surgical procedures and analysis of surgical site infections (SSI) of five European countries. BMC Med Res Methodol. 2022 Aug 12;22(1):225. doi: 10.1186/s12874-022-01702-w.
• Mellinghoff SC, Vehreschild JJ, Liss BJ, Cornely OA. Epidemiology of Surgical Site Infections With Staphylococcus aureus in Europe: Protocol for a Retrospective, Multicenter Study. JMIR Res Protoc. 2018 Mar 12;7(3):e63. doi: 10.2196/resprot.8177. Erratum In: JMIR Res Protoc. 2019 Jan 07;8(1):e10712.

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 1, 2017
• Primary Completion (ACTUAL): January 1, 2021
• Study Completion (ACTUAL): January 31, 2021

Study Registration Dates

• First Submitted: November 20, 2017
• First Submitted That Met QC Criteria: November 22, 2017
• First Posted (ACTUAL): November 27, 2017

Study Record Updates

• Last Update Posted (ACTUAL): May 24, 2021
• Last Update Submitted That Met QC Criteria: May 21, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Disease Attributes; Bacterial Infections; Bacterial Infections and Mycoses; Gram-Positive Bacterial Infections; Infections; Communicable Diseases; Surgical Wound Infection; Wound Infection; Staphylococcal Infections
• Other Study ID Numbers: SALT

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No