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

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)) 3a. Subject is breastfeeding or is planning to breastfeed during the study duration period
• •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 \> 2 cm
• •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 investigational drug study within the washout period of the drug or in a device study that would interfere with mesh implantation or assessment of Incisional Hernia
• •14. Subject with current chemo and/or radiation therapy within 2 weeks of procedure
• •Only exclusion of chemotherapeutic drugs that have:
• •* Cytotoxic effect and/or
• •* Inhibit of cell replication and/or
• •* Impaired tissue healing
• •15. Subject with any 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)
• •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 \>2cm 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