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

Completed

• Conditions: Staphylococcus Aureus
• Interventions: Procedure: decolonization; Other: compliance questionnaire

• Registration Number: NCT03685487
• Lead Sponsor: Centre Hospitalier Universitaire de Saint Etienne

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-09-24
• Study First Submitted QC: 2018-09-25
• Study First Posted: 2018-09-26
• Study Start: 2019-02-12
• Primary Completion: 2020-02-26
• Study Completion: 2020-03-10
• Status Verified: 2021-10
• Last Update Submitted: 2022-01-07
• Last Update Posted: 2022-01-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 215

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
patients with failures of decolonization S. aureus	decolonization	patients with failures of decolonization S. aureus in their nose
patients with failures of decolonization S. aureus	compliance questionnaire	patients with failures of decolonization S. aureus in their nose

Primary Outcome Measures

Name	Time	Method
number of participants with failure of decolonization of nasal carriers of S. aureus	just before surgery	These 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 Outcome Measures

Name	Time	Method
Prevalence of nasal carriage of S. aureus 3 months after cardiac surgery in all patients	3 months
Correlation between nasal dosing of mupirocin and compliance	3 months
Prevalence of nasal carriage of S. aureus just prior to cardiac surgery in all patients	before surgery
Correlation between mupirocin urine metabolite assay associated with mupirocin nasal dosing and decolonization efficacy (failure or not).	3 months

Trial Locations

Locations (1)

Chu Saint-Etienne; 🇫🇷 Saint-Etienne, France