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

• ClinicalTrials.gov Identifier: NCT03685487
• Recruitment Status: Completed
• First Posted: September 26, 2018
• Last Update Posted: January 11, 2022
• Sponsor: Centre Hospitalier Universitaire de Saint Etienne
• Information provided by (Responsible Party): Centre Hospitalier Universitaire de Saint Etienne

Study Description

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.

Condition or disease	Intervention/treatment
Staphylococcus Aureus	Procedure: decolonization; Other: compliance questionnaire

Study Design

• Study Type: Observational
• Actual Enrollment: 215 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Decolonization of Patients Carrying S. Aureus Before Cardiac Surgery: Study of the Risk Factors Associated With Failure
• Actual Study Start Date: February 12, 2019
• Actual Primary Completion Date: February 26, 2020
• Actual Study Completion Date: March 10, 2020

Groups and Cohorts

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

Outcome Measures

Primary Outcome Measures :

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 Outcome Measures :

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 ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• Sampling Method: Non-Probability Sample

Study Population

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

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

Contacts and Locations

Locations

France

Chu Saint-Etienne

Saint-Etienne, France, 42055

Sponsors and Collaborators

Centre Hospitalier Universitaire de Saint Etienne

Investigators

• Principal Investigator: Florence GRATTARD, MD; CHU de Saint Etienne

More Information

• Responsible Party: Centre Hospitalier Universitaire de Saint Etienne
• ClinicalTrials.gov Identifier: NCT03685487
• Other Study ID Numbers: 18CH049; 2018-001505-90 ( Other Identifier: ANSM )
• First Posted: September 26, 2018
• Last Update Posted: January 11, 2022
• Last Verified: October 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Centre Hospitalier Universitaire de Saint Etienne:

decolonization; mupirocin; cardiac surgery