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

This is an interventional prevention trial for Incisional Hernia focused on measuring Incisional Hernia, Prophylactic Mesh, Incisional Hernia of Midline of Abdomen, Midline Laparotomy Read More

Inclusion Criteria:

1. Subject has provided informed consent.
2. Subject is ≥18 years of age at the time of consent.
3. Subject will be undergoing an elective surgery with a planned midline laparotomy with retrorectus mesh placement.

Pre-Operative Exclusion Criteria:

1. Subject is undergoing emergency surgery, i.e. lifesaving procedures performed where patient is in imminent danger of death
2. Subject has a history of allergic reactions after application of poly-L-lactide, poly-trimethylene carbonate copolymers (PLLA/TMC)
3. Subject is pregnant or is planning pregnancy during study duration period (Females of child-bearing potential will be required to provide either a urine or serum pregnancy test (except for subjects who are surgically sterile or are at least 2 years postmenopausal))
4. Subject is unable or unwilling to comply with the study requirements or follow-up schedule
5. Subject is scheduled for another planned surgery, and subsequent surgery would jeopardize previous application of study treatment
6. Subject with a body mass index (BMI) > 45 kg/m2
7. Subjects with the following medical interventions/medical conditions are excluded from participation in the study: uncontrolled diabetes (hemoglobin A1c (Hb1Ac) > 60mmol/mol), cirrhosis, stoma wearers
8. Concomitant ostomy (stoma creation or closure)
9. Subject who had received a mesh in a previous ventral hernia repair or has an existing ventral hernia.
10. Subject with a life expectancy inferior to the study follow-up duration (36 months)
11. Study procedure is a relaparotomy within 30 days of previous abdominal surgery
12. Subject with an American Society of Anesthesiologists (ASA) scores higher than 3
13. Subject has participated in an investigation drug or device study within 30 days of enrolment
14. Subject with current chemo and/or radiation therapy within 2 weeks of procedure
15. Subject with history of ascites
16. Subject has a medical condition that precludes the patient from participation in the opinion of the investigator
17. Subject is undergoing a vascular procedure other than abdominal aortic aneurysm (AAA) surgery (i.e, only AAA surgeries accepted)

Intraoperative Exclusion criteria

1. Subject's study procedure is in a contaminated or infected site as assessed by the Investigator(s) (CDC Class 3 and 4)
2. Abdomen is left open at the end of the procedure
3. Subject has an unsuspected ventral hernia >1cm encountered at the time of laparotomy
4. Inability to close the anterior fascia or keep the mesh securely out of the peritoneal cavity
5. Second-look procedure planned
6. Cases requiring a full-thickness partial resection of the abdominal wall (in particular the midline) because of involvement in neoplastic process or complex fistula
7. Inoperable tumor/poor prognostic cancer/patient non curatively treated
8. Subject has a suture length to wound length ratio< 3.5/1
9. Subject has any ongoing infection at the time of the surgery, that is uncontrolled and/or requiring treatment such as antibiotics
10. Subject was not implanted with Deternia™ Self Gripping Resorbable Mesh
11. Subject requires more than 1 mesh