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SALT
Sponsor study identifier
observational
178,902
5 countries
14
Study Start
August 1, 2017
Actual (reported)Primary Completion
January 1, 2021
Actual (reported)Study Completion
January 31, 2021
Actual (reported)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:
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
January 31, 2021
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
August 1, 2017
Actual (reported)November 20, 2017
Actual (reported)November 27, 2017
Actual (reported)January 1, 2021
Actual (reported)January 31, 2021
Actual (reported)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
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
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
Adult patients with SSI after any surgical procedure.
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
Adult patients with SSI after any surgical procedure
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, 50937, Germany
University Hospital Bonn
Bonn, Germany
Jena University Hospital
Jena, Germany
Hospital of the University of Munich
Munich, Germany
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.
Oliver A Cornely, MD
University of Cologne
178,902 participants (actual enrollment reported by the registry).
First Submitted
November 20, 2017
First Posted
November 27, 2017
Study Start
August 1, 2017
Actual (reported)Contact the study team to confirm eligibility.
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
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.
Primary Completion
January 1, 2021
Actual (reported)Study Completion
January 31, 2021
Actual (reported)Last Updated
May 24, 2021
Record last verified: 2021-05
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Source: ClinicalTrials.gov.
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