Management and Outcome of Mesh Infection After Abdominopl... | NCT06682091

Studies
Management and Outcome of Mesh Infection After Abdominoplasty in a Tertiary Care Centre

NCT06682091

Sponsor

Hospices Civils de Lyon

Status

Completed

Last Update Posted

Nov 12, 2024Actual

Enrollment

209Actual

Phase

Not provided

Conditions

Abdominal Infection

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

Nov 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

Jan 1, 2013Actual

Primary Completion Date

Jan 1, 2023Actual

Completion Date

Jan 1, 2023Actual

First Submitted Date

Jun 7, 2024

First Submission Date that Met QC Criteria

Nov 8, 2024

First Posted Date

Nov 12, 2024Actual

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

Nov 8, 2024

Last Update Posted Date

Nov 12, 2024Actual

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

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Hernia repair is among most frequent surgical interventions. The use of abdominal mesh in hernia repair has become the Gold Standard strategy, reducing the risk of relapse.

The mesh infection risk is estimated lower than 1% in simple situations, but can increase up to 20% in complicated patients. Risk factors are well known, but we lack data regarding the therapeutic strategies and outcomes.

This study aims to describe the characteristics and management of abdominal mesh infections, and the related outcomes.

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

209Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Cohort of patients admitted for an abdominal mesh infection at Hospices Civils de Lyon		No intervention. Retrospective data collection.

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Treatment failure.	Clinical failure = persistance of the infection. Time of failure is the time of change of therapeutic strategy.	Retrospective analysis from initial treatment to any treatment failure within 2010 to 2023

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

parietal mesh infection
age > 18

Exclusion Criteria:

Non French speaking patients.
Persons under tutorship or curatorship.

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

Subjects taken in care for abdominal mesh infection in the Hospices Civils de Lyon from 2010 to 2023.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hospices Civils de Lyon - Hopital de la Croix Rousse - Centre de reference des infection ostéo-articulaires de Lyon		Lyon		69004	France

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided