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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04909424
Acronym
Entero-TAVI
Enrollment
100
Registered
2021-06-01
Start date
2021-06-17
Completion date
2023-11-23
Last updated
2026-03-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aortic Valve Disease

Keywords

Enterococci, Infective endocarditis, Antibiotic prophylaxis, TAVI

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.

Interventions

None listed

Sponsors

Clinique Pasteur
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Enterococci prevalenceAt Day 0 at TAVI intervention time (preoperative)Proportion of patients with Enterococcus feacalis and other Enterococci in inguinal flora before TAVI

Secondary

MeasureTime frameDescription
Skin flora of the groinAt Day 0 at TAVI intervention time (preoperative) before skin disinfectionBacteria profile of inguinal skin
Infectious eventsFrom day of TAVI to 1 year after interventionOccurrence of infective endocarditis or other infectious adverse events

Countries

France

Contacts

STUDY_CHAIREric Bonnet, MD

Clinique Pasteur

STUDY_CHAIRNicolas Combes, MD

Clinique Pasteur

STUDY_CHAIRBenoit Fontenel, MD

Clinique Pasteur

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 7, 2026