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

NCT ID: NCT04909424

Last Updated: 2024-03-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-06-17

Study Completion Date

2023-11-23

Brief Summary

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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

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Conditions

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Aortic Valve Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Clinique Pasteur

OTHER

Sponsor Role lead

Responsible Party

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Dr Benoit Fontenel

Principal investigator, MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Eric Bonnet, MD

Role: STUDY_CHAIR

Clinique Pasteur

Nicolas Combes, MD

Role: STUDY_CHAIR

Clinique Pasteur

Benoit Fontenel, MD

Role: STUDY_CHAIR

Clinique Pasteur

Locations

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Clinique Pasteur

Toulouse, , France

Site Status

Countries

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France

Other Identifiers

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2021-A00370-41

Identifier Type: -

Identifier Source: org_study_id

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