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

The primary objective of this investigation is to evaluate the performance of Deternia™ Self-Gripping Resorbable Mesh when used for suture line reinforcement after elective midline laparotomy in clean and clean-contaminated fields (CDC Classification I and II) at 12 months post-operatively and to demonstrate expected performance in terms of rate of IH occurrence relative to a performance goal (based on historical data on primary laparotomy incision suture closure with small bites only).

The secondary objectives are to evaluate the safety and performance of Deternia™ Self-Gripping Resorbable Mesh when used for suture line reinforcement after elective midline laparotomy in clean and clean contaminated fields (CDC Classification I and II) within 60 months postoperatively.

Inclusion criteria

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

3a. Subject will be undergoing an elective laparoscopy with a planned possibility of a conversion to midline laparotomy or an elective laparoscopy with a planned possible midline laparotomy for specimen extraction.

Pre-Operative Exclusion Criteria:

• Subject is undergoing emergency surgery, i.e. lifesaving procedures performed where patient is in imminent danger of death
• Subject has a history of allergic reactions after application of poly-L-lactide, poly-trimethylene carbonate copolymers (PLLA/TMC)
• 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
• Subject is unable or unwilling to comply with the study requirements or follow-up schedule
• Subject is scheduled for another planned surgery, and subsequent surgery would jeopardize previous application of study treatment
• Subject with a body mass index (BMI) > 45 kg/m2
• 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
• Concomitant ostomy (stoma creation or closure)
• Subject who had received a mesh in a previous ventral hernia repair or has an existing ventral hernia > 2 cm
• Subject with a life expectancy inferior to the study follow-up duration (36 months)
• Study procedure is a relaparotomy within 30 days of previous abdominal surgery
• Subject with an American Society of Anesthesiologists (ASA) scores higher than 3
• 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
• 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
• Subject with any history of ascites
• Subject has a medical condition that precludes the patient from participation in the opinion of the investigator
• Subject is undergoing a vascular procedure other than abdominal aortic aneurysm (AAA) surgery (i.e, only AAA surgeries accepted)

Intraoperative Exclusion criteria

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