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

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.

Study Overview

• Status: Completed
• Conditions: Staphylococcus Aureus
• Intervention / Treatment: Procedure: decolonization; Other: compliance questionnaire

• Study Type: Observational
• Enrollment (Actual): 215

Contacts and Locations

Study Locations

• France
  • Saint-Etienne, France, 42055
    • CHU Saint-Etienne

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

patients with failures of decolonization S. aureus; patients with failures of decolonization S. aureus in their nose

Procedure: 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; Other: compliance questionnaire; We asked if the patient has done the whole decolonization procedure

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Saint Etienne
• Investigators: Principal Investigator: Florence GRATTARD, MD, CHU de Saint Etienne

Study record dates

Study Major Dates

• Study Start (Actual): February 12, 2019
• Primary Completion (Actual): February 26, 2020
• Study Completion (Actual): March 10, 2020

Study Registration Dates

• First Submitted: September 24, 2018
• First Submitted That Met QC Criteria: September 25, 2018
• First Posted (Actual): September 26, 2018

Study Record Updates

• Last Update Posted (Actual): January 11, 2022
• Last Update Submitted That Met QC Criteria: January 7, 2022
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Keywords: cardiac surgery; mupirocin; decolonization
• Other Study ID Numbers: 18CH049; 2018-001505-90 (Other Identifier: ANSM)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No