Prevalence of Cutaneous Enterococci at Femoral Insertion Site in Transcatheter Aortic Valve Implantation (TAVI)

Completed

• Conditions: Aortic Valve Disease

• Registration Number: NCT04909424
• Lead Sponsor: Clinique Pasteur

Brief Summary

The general rules of antibiotic prophylaxis in surgery or interventional medicine include the choice of an antibiotic active on the bacteria most frequently encountered in surgical site infections. This antibiotic must cover, the bacteria present on the skin and recognized as responsible for surgical site infections.

The aim of this study is to identify bacteria found in skin flora in the inguinal region of patients undergoing Transcatheter Aortic Valve Implantation (TAVI). Flora found will allow to evaluate the impact of skin preparation and antibiotic prophylaxis protocols as they are currently practiced.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-05-28
• Study First Submitted QC: 2021-05-28
• Study First Posted: 2021-06-01
• Study Start: 2021-06-17
• Primary Completion: 2022-02-21
• Study Completion: 2023-11-23
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-01
• Last Update Posted: 2024-03-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Patient scheduled for aortic valve replacement by TAVI procedure with trans femoral approach
• Patient with pre-TAVI assessment performed at Clinique Pasteur
• Patient affiliated or beneficiary of a social security scheme
• Patient accepting to participate and having given his no objection

Exclusion Criteria

• TAVI procedure by non-trans femoral approach
• Protected patients: Adults under guardianship or other legal protection; Pregnant or breastfeeding woman; Hospitalized without consent.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Enterococci prevalence	At Day 0 at TAVI intervention time (preoperative)	Proportion of patients with Enterococcus feacalis and other Enterococci in inguinal flora before TAVI

Secondary Outcome Measures

Name	Time	Method
Skin flora of the groin	At Day 0 at TAVI intervention time (preoperative) after skin disinfection	Bacteria profile of inguinal skin
Infectious events	From day of TAVI to 1 year after intervention	Occurrence of infective endocarditis or other infectious adverse events

Trial Locations

Locations (1)

Clinique Pasteur; 🇫🇷 Toulouse, France