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Completed

NCT Number: NCT04909424

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

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.

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Key information

Conditions

Aortic Valve Disease Cardiovascular Diseases Endocarditis Heart Diseases Heart Valve Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Clinique Pasteur

Toulouse, 31076, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. 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

Secondary outcomes

  1. Skin flora of the groin

    Time frame: At Day 0 at TAVI intervention time (preoperative) before skin disinfection

    Bacteria profile of inguinal skin

  2. Skin flora of the groin

    Time frame: At Day 0 at TAVI intervention time (preoperative) after skin disinfection

    Bacteria profile of inguinal skin

  3. Infectious events

    Time frame: From day of TAVI to 1 year after intervention

    Occurrence of infective endocarditis or other infectious adverse events

Sponsors and collaborators

Lead sponsor

Clinique Pasteur

Other

Registry information

Acronym: Entero-TAVI

Important dates

Study start
2021
Primary completion
2022
Study completion
2023
First posted
Jun 1, 2021
Registry last updated
Mar 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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