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

NCT ID: NCT03685487

Last Updated: 2022-01-11

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 215 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-02-12
• Study Completion Date: 2020-03-10

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.

Conditions

Staphylococcus Aureus

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

patients with failures of decolonization S. aureus

patients with failures of decolonization S. aureus in their nose

decolonization

Intervention Type: PROCEDURE

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

compliance questionnaire

Intervention Type: OTHER

We asked if the patient has done the whole decolonization procedure

Interventions

decolonization

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

Intervention Type: PROCEDURE

compliance questionnaire

We asked if the patient has done the whole decolonization procedure

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre Hospitalier Universitaire de Saint Etienne

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Florence GRATTARD, MD

Role: PRINCIPAL_INVESTIGATOR

CHU de Saint Etienne

Locations

Chu Saint-Etienne

Saint-Etienne, , France

Countries

France

Other Identifiers

2018-001505-90

Identifier Type: OTHER

Identifier Source: secondary_id

18CH049

Identifier Type: -

Identifier Source: org_study_id