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

Staphylococcus Aureus Clinical Trial

— STAdécol  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03685487
• Other study ID #: 18CH049
• Secondary ID: 2018-001505-90
• Status: Completed
• Start date: February 12, 2019
• Est. completion date: March 10, 2020

Study information

• Verified date: October 2021
• Source: Centre Hospitalier Universitaire de Saint Etienne
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 215
• Est. completion date: March 10, 2020
• Est. primary completion date: February 26, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Staphylococcus Aureus

Intervention

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

Locations

Country	Name	City	State
France	Chu Saint-Etienne	Saint-Etienne

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Saint Etienne

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Prevalence of nasal carriage of S. aureus just prior to cardiac surgery in all patients		before surgery
Secondary	Prevalence of nasal carriage of S. aureus 3 months after cardiac surgery in all patients		3 months
Secondary	Correlation between nasal dosing of mupirocin and compliance		3 months
Secondary	Correlation between mupirocin urine metabolite assay associated with mupirocin nasal dosing and decolonization efficacy (failure or not).		3 months