Phasix Mesh Use in Complex Open Ventral Hernias Study

Poly-4-hydroxybutyrate Mesh Versus Current Care of Complex Open Ventral Hernias: A Multi-Center Randomized Controlled Trial

The purpose of this study is to compare clinical and patient centered outcomes of biosynthetic poly-4-hydroybutyrate meshes versus current care (synthetic polypropylene mesh or suture) for complex ventral hernia repair. The primary outcome for this study will be patients who are major complication free at 2 years postoperative. This will be a composite of hernia recurrence, reoperation, chronic wound complication, or death. Secondary outcomes include: surgical site occurences such as surgical site infection, seroma, hematoma and skin dehiscence within 90 days postoperative, emergency room visits withing 90 days postoperative, days in hospital up to 90 days postoperative, abdominal pain, and change in patient centered outcomes measured through the modified activities assessment scale (mAAS).

Inclusion Criteria:

• Adult patients (18 years or older) with a complex ventral hernia scheduled for repair

Exclusion Criteria:

• Patients likely to die within 3 years (cirrhosis, terminal cancer, surgeon judgement)
• Unlikely to follow-up (live out of state, unable to be reached by phone or email)
• Non-English and non-Spanish speakers
• Pregnant or breast-feeding patients
• Allergies/hypersensitivities to tetracycline hydrochloride and kanamycin sulfate