Progrip Ventral Study for Sublay Repair

NCT01622127 | Completed

• 1 other identifier: 2011/497
• Study Type: observational
• Target: 55
• Locations: 1 country
• Sites: 1

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.

Conditions

Primary Ventral and Incisional Hernia Repair

Outcome Measures

Primary Outcomes (1)

• Incidence of peri-operative and post-operative complications using Parietex ProGrip™.

  Clinical observation: recurrence, wound complications pain, pain/ chronic pain and other postoperative complications

  24 months after surgery

Secondary Outcomes (1)

• Description and assessment of the use of Parietex™ ProGrip™ larger sizes meshes at time of surgery

  End of surgical procedure

Study Arms (1)

incisional hernias

Device: Parietex ProGrip™

Interventions

Parietex ProGrip™ DEVICE

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.

incisional hernias

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with primary ventral and incisional hernia repair.

You may qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Ghent: lead
• Medtronic - MITG: collaborator

Study Sites (1)

University Hospital Ghent

Ghent, Belgium

Location

Related Links

• Related Info

Study Officials

• Frederik Berrevoet, MD, PhD

  University Hospital, Ghent

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 14, 2012
• First Posted: June 18, 2012
• Study Start: February 1, 2012
• Primary Completion: June 1, 2015
• Study Completion: December 31, 2023
• Last Updated: June 3, 2024

Record last verified: 2024-05

Locations

BE (1)