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ACTIVE NOT RECRUITING
NCT05424484
NA

Mesh Augmented Reinforcement of Abdominal Wall Suture Line to Limit the Rate of Incisional Hernia Occurrence

Sponsor: Medtronic - MITG

View on ClinicalTrials.gov

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

DEVICE

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