Staphylococcus Aureus Surgical Site Infection Multinational Epidemiology in Europe

NCT03353532 | Completed

• 1 other identifier: SALT
• Study Type: observational
• Target: 178,902
• Locations: 5 countries
• Sites: 14

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

Conditions

Staphylococcus Aureus; Wound Infection, Surgical; Epidemiology

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

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

  30 days from surgical procedure

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

  30 days from surgical procedure

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

  30 days from surgical procedure

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

  30 days from surgical procedure

Other Outcomes (3)

• To characterize the composition of the surgical patient population in Europe

  30 days from surgical procedure

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

  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

  30 days from surgical procedure

Study Arms (2)

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients with SSI after any surgical procedure

You may qualify if:

• Age ≥18 years at the time of surgery

You may not qualify if:

• Cases with missing data defined as "missing completely at random" (MCAR)
• Infection at the time of surgery

Sponsors & Collaborators

• University of Cologne: lead
• Pfizer: collaborator

Study Sites (14)

Centre Hospitalier Départemental Vendee

La Roche-sur-Yon, France

Location

Centre Hospitalier et Universitaire de Limoges

Limoges, France

Location

Centre Hospitalier Régional et Universitaire de Tours

Tours, France

Location

University Hospital Cologne

Cologne, North Rhine-Westphalia, 50937, Germany

Location

University Hospital Bonn

Bonn, Germany

Location

Jena University Hospital

Jena, Germany

Location

Hospital of the University of Munich

Munich, Germany

Location

University of Udine and Azienda Sanitaria Universitaria Integrata

Udine, Italy

Location

Hospital Clínic Barcelona

Barcelona, Spain

Location

Institut Hospital del Mar d'Investigacions Mèdiques

Barcelona, Spain

Location

Hospital General Universitario Gregorio Marañón e Instituto de Investigación Sanitaria Gregorio Marañón

Madrid, Spain

Location

Hospital Universitario Ramón y Cajal

Madrid, Spain

Location

Hospital Universitari i Politècnic La Fe

Valencia, Spain

Location

Manchester University NHS Foundation Trust (MFT)

Manchester, United Kingdom

Location

Related Publications (3)

• Mellinghoff SC, Bruns C, Albertsmeier M, Ankert J, Bernard L, Budin S, Bataille C, Classen AY, Cornely FB, Couve-Deacon E, Fernandez Ferrer M, Fortun J, Galar A, Grill E, Guimard T, Hampl JA, Wingen-Heimann S, Horcajada JP, Kohler F, Koll C, Mollar J, Munoz P, Pletz MW, Rutz J, Salmanton-Garcia J, Seifert H, Serracino-Inglott F, Soriano A, Stemler J, Vehreschild JJ, Vilz TO, Naendrup JH, Cornely OA, Liss BJ. Staphylococcus aureus surgical site infection rates in 5 European countries. Antimicrob Resist Infect Control. 2023 Sep 19;12(1):104. doi: 10.1186/s13756-023-01309-w.

  PMID: 37726843 DERIVED

• 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.

  PMID: 35962320 DERIVED

• 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.

  PMID: 29530837 DERIVED

MeSH Terms

Conditions

Staphylococcal Infections; Surgical Wound Infection

Condition Hierarchy (Ancestors)

Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Wound Infection; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Oliver A Cornely, MD

  University of Cologne

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr.

Study Record Dates

• First Submitted: November 20, 2017
• First Posted: November 27, 2017
• Study Start: August 1, 2017
• Primary Completion: January 1, 2021
• Study Completion: January 31, 2021
• Last Updated: May 24, 2021

Record last verified: 2021-05

Locations

DE (4); IT (1); GB (1); FR (3); ES (5)