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NCT04909424 Clinical Trial

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

Aortic Valve Disease Clinical Trial

— Entero-TAVI  

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04909424
Other study ID # 2021-A00370-41
Secondary ID
Status Completed
Phase
First received
Last updated
Start date June 17, 2021
Est. completion date November 23, 2023

Study information
Verified date March 2024
Source Clinique Pasteur
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 100
Est. completion date November 23, 2023
Est. primary completion date February 21, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Locations
Country Name City State
France Clinique Pasteur Toulouse

Sponsors (1)
Lead Sponsor Collaborator
Clinique Pasteur

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary Enterococci prevalence Proportion of patients with Enterococcus feacalis and other Enterococci in inguinal flora before TAVI At Day 0 at TAVI intervention time (preoperative)
Secondary Skin flora of the groin Bacteria profile of inguinal skin At Day 0 at TAVI intervention time (preoperative) before skin disinfection
Secondary Skin flora of the groin Bacteria profile of inguinal skin At Day 0 at TAVI intervention time (preoperative) after skin disinfection
Secondary Infectious events Occurrence of infective endocarditis or other infectious adverse events From day of TAVI to 1 year after intervention
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