Progrip Ventral Study for Sublay Repair

May 31, 2024 updated by: University Hospital, Ghent

Efficacy of Self-fixating Mesh in Ventral and Incisional Hernia Repair

A novel concept of self-gripping mesh has been developed to achieve secure and long-term posterior wall reinforcement. ProGrip™ mesh is a lightweight (40g/m2) monofilament polypropylene or polyester mesh with resorbable polylactic acid (PLA) micro-grips, which provide self-gripping properties during the first few months after implantation. The self-fixation of the mesh to the underlying tissues is instantly achieved at application, limiting or avoiding the requirement of sutures (which can penetrate underlying tissues and damage cutaneous nerves), and providing a near tension-¬free repair.

Case series confirmed that Parietex ProGrip™ placed in onlay position allows a safe and painless treatment of incisional hernias and provides secure and efficient fixation mesh. On this basis, larger sizes Parietex ProGrip™ meshes have been developed for larger incisional hernia defect treatment. In order to assess the clinical outcomes following the use of ProGrip™ larger sizes in incisional hernia repair, this mono-center observational study has been initiated.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

55

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Ghent, Belgium
        • University Hospital Ghent

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients with primary ventral and incisional hernia repair.

Description

Inclusion Criteria:

  • All patients at participating hospital undergoing incisional hernia repair by using retromuscular placement by open approach.
  • Defect size: 5cm ≤ width*, 10 cm ≤ length ≤ 20 cm

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
incisional hernias
Device: Parietex ProGrip™
ProGrip™ mesh is a lightweight (40g/m2) monofilament polypropylene or polyester mesh with resorbable polylactic acid (PLA) micro-grips, which provide self-gripping properties during the first few months after implantation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of peri-operative and post-operative complications using Parietex ProGrip™.
Time Frame: 24 months after surgery
Clinical observation: recurrence, wound complications pain, pain/ chronic pain and other postoperative complications
24 months after surgery

Secondary Outcome Measures

Outcome Measure
Time Frame
Description and assessment of the use of Parietex™ ProGrip™ larger sizes meshes at time of surgery
Time Frame: End of surgical procedure
End of surgical procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Ghent

Collaborators

Medtronic - MITG

Investigators

  • Principal Investigator: Frederik Berrevoet, MD, PhD, University Hospital, Ghent

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2012

Primary Completion (Actual)

June 1, 2015

Study Completion (Actual)

December 31, 2023

Study Registration Dates

First Submitted

June 14, 2012

First Submitted That Met QC Criteria

June 14, 2012

First Posted (Estimated)

June 18, 2012

Study Record Updates

Last Update Posted (Actual)

June 3, 2024

Last Update Submitted That Met QC Criteria

May 31, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2011/497

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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