The purpose of this prospective, pivotal, multi-center, single-arm, pre-market, investigational clinical study is to assess the safety and performance of Deterniaâ„¢ 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 and European post-market clinical follow-up needs (PMCF). 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).
Who can participate
Age range18 Years
SexALL
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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.
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)