Study of Absorbable Biosynthetic Meshes in Contaminated V... | NCT04132986

Studies
Study of Absorbable Biosynthetic Meshes in Contaminated Ventral Hernia Repair

NCT04132986

Sponsor

University Hospital, Strasbourg, France

Status

Unknown status

Last Update Posted

Dec 14, 2021Actual

Enrollment

200Estimated

Phase

Not provided

Conditions

Ventral Hernia Repair

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 2021

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 1, 2019Actual

Primary Completion Date

Jun 2023Estimated

Completion Date

Jun 30, 2023Estimated

First Submitted Date

Oct 14, 2019

First Submission Date that Met QC Criteria

Oct 18, 2019

First Posted Date

Oct 21, 2019Actual

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 29, 2021

Last Update Posted Date

Dec 14, 2021Actual

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 potential value of biological and biosynthetic meshes is their ability to integrate and remodel the wall in a contaminated environment in complex surgical situations. However, postoperative morbidity and recurrence rate for biologic prostheses are high. The delay to evaluate biosynthetic prostheses is not enough at present, and the high cost of biological prostheses requires a parsimonious use of this type of material. The interest of absorbable biosynthetic prostheses remains to be demonstrated in terms of postoperative complications and long-term recurrence. Current studies have been done on groups with few subjects and in clean surgery.

The primary purpose is to describe the number of complications of the operative site at 12 months, including infectious and noninfectious complications as hematoma and seroma type. The secondary purpose is to describe the number of recurrent ventral hernia at 12 months.

The ventral hernia repair is a frequent operation of general surgery. Thanks to this descriptive work considering the new therapeutic offer with absorbable polymers, it would make possible to update the knowledge of the surgeons and to bring new elements of discussion in the surgical decision.

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

200Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The main criterion will be clinical outcomes : complications and recurrence. It will be expressed in terms of complication according to the Clavien-Dindo classification		Files analysed retrospectily from May 1st, 2016 to December 31, 2021 will be examined

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Male or female adult patient ( ≥18 years)
Patient who has agreed to the use of his medical data for the purposes of this research,
Patient having been operated between May 2016 and September 2018 in a programmed or urgent surgery, as part of clean / contaminated to dirty surgery at mVHWG grade 3 in the centers participating in the study,
Patient who benefited between May 2016 and September 2018 from a biosynthetic mesh

Exclusion Criteria:

Patient who has not consented to the use of her medical data for the purposes of this research,
Patients who have benefited from the placement of a Phasix® ST biosynthetic mesh in intraperitoneal or Phasix® in retro-muscular prophylaxis,
Patient under safeguard of justice,
Patient under guardianship or curatorship.

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Male or female adult patient having been operated between May 2016 and September 2018 in a programmed or urgent surgery, as part of clean / contaminated to dirty surgery at mVHWG grade 3 in the centers participating in the study,

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Benoît ROMAIN, MD	Contact	33 3 88 12 72 37		benoit.romain@chru-strasbourg.fr

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Service de chirurgie générale et digestive	Recruiting	Strasbourg		67098	France

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
33492554	Derived	Charleux-Muller D, Hurel R, Fabacher T, Brigand C, Rohr S, Manfredelli S, Passot G, Ortega-Deballon P, Dubuisson V, Renard Y, Romain B. Slowly absorbable mesh in contaminated incisional hernia repair: results of a French multicenter study. Hernia. 2021 Aug;25(4):1051-1059. doi: 10.1007/s10029-020-02366-5. Epub 2021 Jan 25.