NCT03353532: SALT

Staphylococcus Aureus Surgical Site Infection Multinational Epidemiology in Europe

Completed Last updated 24 May 2021

What this trial tests

trial in Staphylococcus Aureus in 178,902 participants. Completed in 31 January 2021.

Timeline

1 August 2017

Primary endpoint
1 January 2021

31 January 2021

Quick facts

Lead sponsor	University of Cologne
Status	Completed
Study type	OBSERVATIONAL
Enrollment	178,902
Start date	1 August 2017
Primary completion	1 January 2021
Estimated completion	31 January 2021
Sites	14 locations across France, Italy, United Kingdom, Germany, Spain

Conditions studied

• Staphylococcus Aureus — all drugs for Staphylococcus Aureus →
• Wound Infection, Surgical — all drugs for Wound Infection, Surgical →
• Epidemiology — all drugs for Epidemiology →

Sponsor

University of Cologne

Who can join

18 and older, any sex, with Staphylococcus Aureus or Wound Infection, Surgical. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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

Publications & conference data

7 peer-reviewed publications reference this trial (live from Europe PMC):

1. Epidemiology of Surgical Site Infections With Staphylococcus aureus in Europe: Protocol for a Retrospective, Multicenter Study.
   Mellinghoff SC, Vehreschild JJ, Liss BJ, Cornely OA. · · 2018 · cited 10× · PMID 29530837 · DOI 10.2196/resprot.8177
2. Staphylococcus aureus surgical site infection rates in 5 European countries.
   Mellinghoff SC, Bruns C, Albertsmeier M, Ankert J, et al · · 2023 · cited 7× · PMID 37726843 · DOI 10.1186/s13756-023-01309-w
3. Harmonized procedure coding system for surgical procedures and analysis of surgical site infections (SSI) of five European countries.
   Mellinghoff SC, Bruns C, Al-Monajjed R, Cornely FB, et al · · 2022 · cited 4× · PMID 35962320 · DOI 10.1186/s12874-022-01702-w
4. Individual and institutional predisposing factors of MRSA surgical site infection and outcomes-a retrospective case-control-study in 14 European high-volume surgical centres.
   Rutz J, Naendrup JH, Bruns C, Classen AY, et al · · 2024 · cited 1× · PMID 38577701 · DOI 10.1093/jacamr/dlae046
5. 1236. Staphylococcus aureus Surgical Site Infection: Epidemiology in Europe (SALT)
   Mellinghoff S, Bruns C, Albertrsmeier M, Bassetti M, et al · · 2019
6. 1235. A Survey of Surgical Site Infection (SSI) Surveillance Practices in US Hospitals, and their Association with SSI Rates
   Pop-Vicas A, Osman F, Safdar N. · · 2019
7. 1234. Mental Models of Surgical Site Infection Prevention Among Surgical Technicians and Nurses
   Pop-Vicas A, Young A, Knobloch M, Safdar N. · · 2019