Clinical trial NCT03685487: Decolonization of Patients Carrying S. Aureus Before Cardiac Surgery: Study of the Risk Factors Associated With Failure
Official title: Decolonization of Patients Carrying S. Aureus Before Cardiac Surgery: Study of the Risk Factors Associated With Failure
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Staphylococcus Aureus
Keywords: decolonization
mupirocin
cardiac surgery
Lead sponsor: Centre Hospitalier Universitaire de Saint Etienne
Sponsor class: OTHER
First posted: 2018-09-26
Enrollment: 215
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study will be offered to all major patient who needs cardiac surgery

Brief summary: Staphylococcus aureus nasal carriage is a well-known risk factor for S. aureus surgical site infections (SSI). According to a recent study demonstrating 60% reduction risk of SSI due this bacterium after patients' screening and decolonization, recent French and WHO guidelines recommend in cardiac surgery the decolonization of nasal S. aureus carriers before surgery. In practice the decolonization procedures are not well-defined according notably to the duration and time of delivery before surgery and doses of topical antimicrobial drugs. The aim of the proposed study is to investigate the factors associated with failures of S. aureus decolonization: carriage state, compliance with treatment, S. aureus capacity of internalization in nasal epithelial cells, resistance to antimicrobial drugs used. This study will allow (i) to measure the frequency of patients with residual S. aureus carriage just before surgery, whatever they have been decolonized or not, (ii) to characterize the S. aureus nasal carriage state of patients before surgery, and (iii) to investigate the adding value of mupirocin dosage in the nose and urines of decolonized patients as a marker of compliance and efficacy of the decolonization process.


Eligibility criteria: Inclusion Criteria:

* Patient to benefit from cardiac surgery scheduled at Saint-Etienne University Hospital
* Surgery of first intention (no resumption)
* Patient affiliated or entitled to a social security scheme
* Patient agreeing to participate in the study and having signed the informed consent

Exclusion Criteria:

* Surgery in a context of infection
* Surgery in an emergency and semi-emergency context
* Protected major patient
* Pregnant

Primary outcomes:
measure: number of participants with failure of decolonization of nasal carriers of S. aureus
timeFrame: just before surgery
Secondary outcomes:
measure: Prevalence of nasal carriage of S. aureus just prior to cardiac surgery in all patients
timeFrame: before surgery
measure: Prevalence of nasal carriage of S. aureus 3 months after cardiac surgery in all patients
timeFrame: 3 months
measure: Correlation between nasal dosing of mupirocin and compliance
timeFrame: 3 months
measure: Correlation between mupirocin urine metabolite assay associated with mupirocin nasal dosing and decolonization efficacy (failure or not).
timeFrame: 3 months
Other outcomes:
Locations:
city: Saint-Etienne
country: France
facility: Chu Saint-Etienne
Study officials:
affiliation: CHU de Saint Etienne
name: Florence GRATTARD, MD
role: PRINCIPAL_INVESTIGATOR
References: