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OpenTrials
Completed

NCT Number: NCT01622127

Progrip Ventral Study for Sublay 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.

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Key information

Conditions

Primary Ventral and Incisional Hernia Repair

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital Ghent

Ghent, Belgium

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. 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

Secondary outcomes

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

    Time frame: End of surgical procedure

Sponsors and collaborators

Lead sponsor

University Hospital, Ghent

Other

Collaborators

  • Medtronic - MITG

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2015
Study completion
2023
First posted
Jun 18, 2012
Registry last updated
Jun 3, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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