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Decolonization of Patients Carrying S. Aureus Before Cardiac Surgery: Study of the Risk Factors Associated With Failure

Decolonization of Patients Carrying S. Aureus Before Cardiac Surgery: Study of the Risk Factors Associated With Failure

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03685487
Acronym
STAdécol
Enrollment
215
Registered
2018-09-26
Start date
2019-02-12
Completion date
2020-03-10
Last updated
2022-01-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Staphylococcus Aureus

Keywords

decolonization, mupirocin, 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.

Interventions

current practice : V1 : consultation to the service : nasal sample for all 5 days before surgery : order sent with decolonization procedure : nasal mupirocin, shower and mouthwash V2 : admission to the service : nasal sample for all and urine sample for decolonized patients V3 : nasal sample for all

We asked if the patient has done the whole decolonization procedure

Sponsors

Centre Hospitalier Universitaire de Saint Etienne
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
number of participants with failure of decolonization of nasal carriers of S. aureusjust before surgeryThese patients were screened positive for S. aureus in nasal swab culture collected during the preoperative consultation of cardiac surgery, who received a decolonization prescription and who are again detected positive in culture for S. aureus on the nasal collection performed on admission to the surgery department (just before surgery).

Secondary

MeasureTime frame
Prevalence of nasal carriage of S. aureus just prior to cardiac surgery in all patientsbefore surgery
Prevalence of nasal carriage of S. aureus 3 months after cardiac surgery in all patients3 months
Correlation between nasal dosing of mupirocin and compliance3 months
Correlation between mupirocin urine metabolite assay associated with mupirocin nasal dosing and decolonization efficacy (failure or not).3 months

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026