Clinical trial NCT03353532: Staphylococcus Aureus Surgical Site Infection Multinational Epidemiology in Europe
Official title: Staphylococcus Aureus Surgical Site Infection Multinational Epidemiology in Europe
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Staphylococcus Aureus
Wound Infection, Surgical
Epidemiology
Lead sponsor: University of Cologne
Sponsor class: OTHER
Collaborators: name: Pfizer
First posted: 2017-11-27
Enrollment: 178902
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients with SSI after any surgical procedure

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


Eligibility criteria: 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

Primary outcomes:
measure: To determine overall incidence of Staphylococcus aureus surgical site infections in Europe
timeFrame: 30 days from surgical procedure
measure: To determine procedure specific incidence of Staphylococcus aureus surgical site infections in Europe
timeFrame: 30 days from surgical procedure
Secondary outcomes:
measure: To determine the overall outcomes of Staphylococcus aureus surgical site infections in Europe
timeFrame: 30 days from surgical procedure
measure: To determine the procedure specific outcomes of Staphylococcus aureus surgical site infections in Europe
timeFrame: 30 days from surgical procedure
measure: To determine the overall economic burden of Staphylococcus aureus surgical site infections in Europe
timeFrame: 30 days from surgical procedure
measure: To determine the procedure specific economic burden of Staphylococcus aureus surgical site infections in Europe
timeFrame: 30 days from surgical procedure
Other outcomes:
measure: To characterize the composition of the surgical patient population in Europe
timeFrame: 30 days from surgical procedure
measure: To estimate the number of patients at risk for Staphylococcus aureus surgical site infection
timeFrame: 30 days from surgical procedure
measure: To estimate the economic burden, including direct treatment and indirect costs, imposed by Staphylococcus aureus surgical site infections in Europe
timeFrame: 30 days from surgical procedure
Locations:
city: La Roche-sur-Yon
country: France
facility: Centre Hospitalier Départemental Vendee
city: Limoges
country: France
facility: Centre Hospitalier et Universitaire de Limoges
city: Tours
country: France
facility: Centre Hospitalier Régional et Universitaire de Tours
city: Cologne
country: Germany
facility: University Hospital Cologne
state: NRW
city: Bonn
country: Germany
facility: University Hospital Bonn
city: Jena
country: Germany
facility: Jena University Hospital
city: Munich
country: Germany
facility: Hospital of the University of Munich
city: Udine
country: Italy
facility: University of Udine and Azienda Sanitaria Universitaria Integrata
city: Barcelona
country: Spain
facility: Hospital Clínic Barcelona
city: Barcelona
country: Spain
facility: Institut Hospital del Mar d'Investigacions Mèdiques
city: Madrid
country: Spain
facility: Hospital General Universitario Gregorio Marañón e Instituto de Investigación Sanitaria Gregorio Marañón
city: Madrid
country: Spain
facility: Hospital Universitario Ramón y Cajal
city: Valencia
country: Spain
facility: Hospital Universitari i Politècnic La Fe
city: Manchester
country: United Kingdom
facility: Manchester University NHS Foundation Trust (MFT)
Study officials:
affiliation: University of Cologne
name: Oliver A Cornely, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.