Staphylococcus Aureus Surgical Site Infection Multinational Epidemiology in Europe
NCT ID: NCT03353532
Last Updated: 2021-05-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
178902 participants
OBSERVATIONAL
2017-08-01
2021-01-31
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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CASE_CONTROL
RETROSPECTIVE
Study Groups
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Cohort
Adult patients with SSI after any surgical procedure.
No interventions assigned to this group
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
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Infection at the time of surgery
18 Years
ALL
No
Sponsors
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Pfizer
INDUSTRY
University of Cologne
OTHER
Responsible Party
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Oliver Cornely, MD
Prof. Dr.
Principal Investigators
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Oliver A Cornely, MD
Role: PRINCIPAL_INVESTIGATOR
University of Cologne
Locations
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Centre Hospitalier Départemental Vendee
La Roche-sur-Yon, , France
Centre Hospitalier et Universitaire de Limoges
Limoges, , France
Centre Hospitalier Régional et Universitaire de Tours
Tours, , France
University Hospital Cologne
Cologne, North Rhine-Westphalia, Germany
University Hospital Bonn
Bonn, , Germany
Jena University Hospital
Jena, , Germany
Hospital of the University of Munich
Munich, , Germany
University of Udine and Azienda Sanitaria Universitaria Integrata
Udine, , Italy
Hospital Clínic Barcelona
Barcelona, , Spain
Institut Hospital del Mar d'Investigacions Mèdiques
Barcelona, , Spain
Hospital General Universitario Gregorio Marañón e Instituto de Investigación Sanitaria Gregorio Marañón
Madrid, , Spain
Hospital Universitario Ramón y Cajal
Madrid, , Spain
Hospital Universitari i Politècnic La Fe
Valencia, , Spain
Manchester University NHS Foundation Trust (MFT)
Manchester, , United Kingdom
Countries
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References
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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.
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.
Other Identifiers
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SALT
Identifier Type: -
Identifier Source: org_study_id
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