Progrip Ventral Study for Sublay Repair

Completed

• Conditions: Primary Ventral and Incisional Hernia Repair
• Interventions: Device: Parietex ProGrip™

• Registration Number: NCT01622127
• Lead Sponsor: University Hospital, Ghent

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-02
• Study First Submitted: 2012-06-14
• Study First Submitted QC: 2012-06-14
• Study First Posted: 2012-06-18
• Primary Completion: 2015-06
• Study Completion: 2023-12-31
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-31
• Last Update Posted: 2024-06-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 55

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
incisional hernias	Parietex ProGrip™	-

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Description and assessment of the use of Parietex™ ProGrip™ larger sizes meshes at time of surgery	End of surgical procedure

Trial Locations

Locations (1)

University Hospital Ghent; 🇧🇪 Ghent, Belgium