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

NCT03685487 | Completed

• 2 other identifiers: 18CH0492018-001505-90
• Study Type: observational
• Target: 215
• Locations: 1 country
• Sites: 1

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

Keywords

decolonization; mupirocin; cardiac surgery

Outcome Measures

Primary Outcomes (1)

• number of participants with failure of decolonization of nasal carriers of S. aureus

  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).

  just before surgery

Secondary Outcomes (4)

• Prevalence of nasal carriage of S. aureus just prior to cardiac surgery in all patients

  before surgery

• 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

• Correlation between mupirocin urine metabolite assay associated with mupirocin nasal dosing and decolonization efficacy (failure or not).

  3 months

Study Arms (1)

patients with failures of decolonization S. aureus

patients with failures of decolonization S. aureus in their nose

Procedure: decolonization; Other: compliance questionnaire

Interventions

decolonization 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

patients with failures of decolonization S. aureus

compliance questionnaire OTHER

We asked if the patient has done the whole decolonization procedure

patients with failures of decolonization S. aureus

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study will be offered to all major patient who needs cardiac surgery

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Saint Etienne: lead

Study Sites (1)

Chu Saint-Etienne

Saint-Etienne, 42055, France

Location

MeSH Terms

Conditions

Staphylococcal Infections

Condition Hierarchy (Ancestors)

Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Study Officials

• Florence GRATTARD, MD

  CHU de Saint Etienne

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 24, 2018
• First Posted: September 26, 2018
• Study Start: February 12, 2019
• Primary Completion: February 26, 2020
• Study Completion: March 10, 2020
• Last Updated: January 11, 2022

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)