Progrip Ventral Study for Sublay Repair

Ghent University Hospital (UZ)

Status: Completed

Conditions: Primary Ventral and Incisional Hernia Repair

Treatments: Device: Parietex ProGrip™

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT01622127

2011/497

Details and patient eligibility

About

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.

Enrollment: 55 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

55 participants in 1 patient group

incisional hernias

Treatment:

Device: Parietex ProGrip™