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

NCT04909424 | Completed

• 1 other identifier: 2021-A00370-41
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Aortic Valve Disease

Keywords

Enterococci; Infective endocarditis; Antibiotic prophylaxis; TAVI

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Skin flora of the groin

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

• Skin flora of the groin

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

• Infectious events

  From day of TAVI to 1 year after intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

In hospital patients for pre TAVI assessment at Clinique Pasteur

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Clinique Pasteur: lead

Study Sites (1)

Clinique Pasteur

Toulouse, 31076, France

Location

MeSH Terms

Conditions

Aortic Valve Disease; Endocarditis

Condition Hierarchy (Ancestors)

Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases

Study Officials

• Eric Bonnet, MD

  Clinique Pasteur

  STUDY CHAIR

• Nicolas Combes, MD

  Clinique Pasteur

  STUDY CHAIR

• Benoit Fontenel, MD

  Clinique Pasteur

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 28, 2021
• First Posted: June 1, 2021
• Study Start: June 17, 2021
• Primary Completion: February 21, 2022
• Study Completion: November 23, 2023
• Last Updated: March 6, 2026

Record last verified: 2024-03

Locations

FR (1)