Progrip Ventral Study for Sublay Repair

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01622127

Enrollment

Registered

2012-06-18

Start date

2012-02-29

Completion date

2023-12-31

Last updated

2024-06-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Primary Ventral and Incisional Hernia Repair

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.

Interventions

DEVICEParietex 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.

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

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

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026