Table 3 Eligibility
Inclusion Criteria | Exclusion Criteria |
|---|---|
Patient is female or male and ≥ 18 years old | Patient participates simultaneously in an investigational drug or medical device study |
Female patients are incapable of pregnancy or must be using adequate contraception and are not in lactation | Patient has an acute incarcerated hernia Patient had a previous mesh repair at the same site |
Patient has only a vertical aponeurotic incision | Enterotomy to be performed during hernia repair at Visit 2 |
Patient has an incisional hernia with a hernia size ≥ 3 cm | Patient is on anti-coagulation therapy |
Patient is capable to understand and to follow the instructions | Patient is known or assessed to be non-compliant |
Written informed consent is available | Patient must not get any additional surgical treatment at the same time (e. g. cholecystectomy) |
Patient had no mesh implantation at the same site during a previous operation | Patient is immune incompetent (e. g. chemotherapy) |