Skip to main content
OpenTrials
Completed

NCT Number: NCT03685487

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Chu Saint-Etienne

Saint-Etienne, 42055, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

compliance questionnaire

Other

We asked if the patient has done the whole decolonization procedure

Primary outcomes

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

    Time frame: 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 outcomes

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

    Time frame: before surgery

  2. Prevalence of nasal carriage of S. aureus 3 months after cardiac surgery in all patients

    Time frame: 3 months

  3. Correlation between nasal dosing of mupirocin and compliance

    Time frame: 3 months

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

    Time frame: 3 months

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Saint Etienne

Other

Registry information

Acronym: STAdécol

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Sep 26, 2018
Registry last updated
Jan 11, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.