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Mesh Augmented Reinforcement of Abdominal Wall Suture Line to Limit the Rate of Incisional Hernia Occurrence
Sponsor: Medtronic - MITG
Summary
The purpose of this prospective, pivotal, multi-center, single-arm, pre-market, investigational clinical study is to assess the safety and performance of Deternia™ Self-Gripping Resorbable Mesh when used for suture line reinforcement after midline laparotomy in clean and clean-contaminated fields (CDC Classification I and II). Data from this study will be used to support market applications. The indication under investigation is reinforcement of midline laparotomy to limit the rate of incisional hernia (IH) in clean and clean-contaminated surgeries (CDC Classification I and II).
Official title: Mesh Augmented Reinforcement of Abdominal Wall Suture Line in Patients Undergoing Midline Laparotomy to Limit the Rate of Incisional Hernia Occurrence
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
123
Start Date
2022-11-22
Completion Date
2028-09
Last Updated
2025-11-19
Healthy Volunteers
No
Interventions
Self-Gripping Resorbable Mesh
Self-Gripping Resorbable Mesh used for suture line reinforcement after midline laparotomy in clean and clean-contaminated fields (CDC Classification I and II).
Locations (13)
Clinical Hospital Center Sisters of Mercy
Zagreb, Croatia
University Hospital Center of Zagreb
Zagreb, Croatia
Klinikum Braunschweig
Braunschweig, Germany
Pius-Hospital Medical Campus University of Oldenburg
Oldenburg, Germany
Barmherzige Brüder Regensburg
Regensburg, Germany
IJsselland Ziekenhuis
Capelle aan den IJssel, Netherlands
Maastricht University Medical Center
Maastricht, Netherlands
Consorci Sanitari de l'Anoia Hospital Universitari d'Igualada
Igualada, Barcelona, Spain
Hospital de la Santa Creu i Sant Pau
Barcelona, Spain
Hospital Universitario Ramón y Cajal
Madrid, Spain
Hospital Universitario Virgen Macarena
Seville, Spain
Countess Of Chester Hospital NHS Foundation Trust
Chester, Cheshire, United Kingdom
Cardiff and Vale University Local Health Board
Cardiff, United Kingdom