Prevalence of Cutaneous Enterococci at Femoral Insertion... | NCT04909424

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

NCT04909424

Sponsor

Clinique Pasteur

Status

Completed

Last Update Posted

Mar 6, 2026Actual

Enrollment

100Actual

Phase

Not provided

Conditions

Aortic Valve Disease

Interventions

Not provided

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 17, 2021Actual

Primary Completion Date

Feb 21, 2022Actual

Completion Date

Nov 23, 2023Actual

First Submitted Date

May 28, 2021

First Submission Date that Met QC Criteria

May 28, 2021

First Posted Date

Jun 1, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 5, 2026

Last Update Posted Date

Mar 6, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

100Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Skin flora of the groin	Bacteria profile of inguinal skin	At Day 0 at TAVI intervention time (preoperative) before skin disinfection
Skin flora of the groin	Bacteria profile of inguinal skin

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

In hospital patients for pre TAVI assessment at Clinique Pasteur

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Eric Bonnet, MD	Clinique Pasteur	Study Chair
Nicolas Combes, MD	Clinique Pasteur	Study Chair
Benoit Fontenel, MD	Clinique Pasteur	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Clinique Pasteur		Toulouse		31076	France

Condition Browse Module

MeSH Terms

ID	Term
D000082862	Aortic Valve Disease
D004696	Endocarditis

Ancestor Terms

ID	Term
D006349	Heart Valve Diseases
D006331	Heart Diseases
D002318	Cardiovascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided