Staphylococcus Aureus Surgical Site Infection Multinational Epidemiology in Europe

Staphylococcus Aureus Clinical Trial

— SALT  

Official title:

Staphylococcus Aureus Surgical Site Infection Multinational Epidemiology in Europe

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03353532
• Other study ID #: SALT
• Status: Completed
• Start date: August 1, 2017
• Est. completion date: January 31, 2021

Study information

• Verified date: May 2021
• Source: University of Cologne
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 178902
• Est. completion date: January 31, 2021
• Est. primary completion date: January 1, 2021
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Communicable Diseases
• Epidemiology
• Infection
• Staphylococcal Infections
• Staphylococcus Aureus
• Surgical Wound Infection
• Wound Infection
• Wound Infection, Surgical

Locations

Country	Name	City	State
France	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
Germany	University Hospital Bonn	Bonn
Germany	University Hospital Cologne	Cologne	NRW
Germany	Jena University Hospital	Jena
Germany	Hospital of the University of Munich	Munich
Italy	University of Udine and Azienda Sanitaria Universitaria Integrata	Udine
Spain	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
United Kingdom	Manchester University NHS Foundation Trust (MFT)	Manchester

Sponsors (2)

Lead Sponsor	Collaborator
University of Cologne	Pfizer

Countries where clinical trial is conducted

France,  Germany,  Italy,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	To characterize the composition of the surgical patient population in Europe	The composition of the surgical patient population in Europe will be performed by subgroup Analysis of the cohort	30 days from surgical procedure
Other	To estimate the number of patients at risk for Staphylococcus aureus surgical site infection	This will be extrapolated from epidemiologcal data assessed within the cohort	30 days from surgical procedure
Other	To estimate the economic burden, including direct treatment and indirect costs, imposed by Staphylococcus aureus surgical site infections in Europe	Direct and indirect Treatment costs will be assessed within the case-control part. Cases and controls will be compared regarding costs.	30 days from surgical procedure
Primary	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
Primary	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	To determine the overall outcomes of Staphylococcus aureus surgical site infections in Europe	The Outcome will be assessed within the case-control part and achieved by comparison of Overall Outcome of cases and controls	30 days from surgical procedure
Secondary	To determine the procedure specific outcomes of Staphylococcus aureus surgical site infections in Europe	The Outcome will be assessed within the case-control part and achieved by comparison of procedure specific Outcome of cases and controls	30 days from surgical procedure
Secondary	To determine the overall economic burden of Staphylococcus aureus surgical site infections in Europe	The economic burden will be assessed within the case-control part and achieved by comparison of Overall economic burden (i.e. ICU Treatment, hemodialysis and mechanical Ventilation) of cases and controls	30 days from surgical procedure
Secondary	To determine the procedure specific economic burden of Staphylococcus aureus surgical site infections in Europe	The economic burden will be assessed within the case-control part and achieved by comparison of procedure specific economic burden (i.e. ICU Treatment, hemodialysis and mechanical Ventilation) of cases and controls	30 days from surgical procedure