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

March 1, 2024 updated by: Dr Benoit Fontenel, Clinique Pasteur

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Toulouse, France, 31076
        • Clinique PASTEUR

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

In hospital patients for pre TAVI assessment at Clinique Pasteur

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Enterococci prevalence
Time Frame: At Day 0 at TAVI intervention time (preoperative)
Proportion of patients with Enterococcus feacalis and other Enterococci in inguinal flora before TAVI
At Day 0 at TAVI intervention time (preoperative)

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Clinique Pasteur

Investigators

  • Study Chair: Eric Bonnet, MD, Clinique PASTEUR
  • Study Chair: Nicolas Combes, MD, Clinique PASTEUR
  • Study Chair: Benoit Fontenel, MD, Clinique PASTEUR

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 17, 2021

Primary Completion (Actual)

February 21, 2022

Study Completion (Actual)

November 23, 2023

Study Registration Dates

First Submitted

May 28, 2021

First Submitted That Met QC Criteria

May 28, 2021

First Posted (Actual)

June 1, 2021

Study Record Updates

Last Update Posted (Actual)

March 4, 2024

Last Update Submitted That Met QC Criteria

March 1, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2021-A00370-41

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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