MARS study
Research type
Research Study
Full title
Mesh Augmented Reinforcement of Abdominal Wall Suture Line in Patients Undergoing Midline Laparotomy to Limit the Rate of Incisional Hernia (IH) Occurrence
IRAS ID
314752
Contact name
Dale Vimalachandran
Contact email
Sponsor organisation
Sofradim Production S.A.S.U,
Clinicaltrials.gov Identifier
Duration of Study in the UK
4 years, 7 months, 26 days
Research summary
The purpose of this prospective, pivotal, multi-center, single-arm cohort, 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. A laparotomy is a planned open surgery performed by a midline incision (cut) at the abdominal cavity (belly). The study mesh is intended to be used for the reinforcement of abdominal wall soft tissues where weakness exists in procedures involving abdominal suture line reinforcement. It is designed to provide strength and tissue integration throughout the critical healing period. It is composed by fully resorbable materials which are completely resorbed in 3 to 5 years post-implantation and it has absorbable grips on one side to hold the mesh in contact with the tissue.
REC name
North West - Greater Manchester East Research Ethics Committee
REC reference
22/NW/0158
Date of REC Opinion
6 Sep 2022
REC opinion
Further Information Favourable Opinion