ENHANCE: A Prospective EvaluatioN of Permacol™ in tHe Repair of Complex AbdomiNal Wall CasEs

Exclusion Criteria

• •All subjects who meet any of the following criteria should not be enrolled into the study:
• •1. Subjects who are pregnant
• •2. Subjects with a medical condition that in the opinion of the investigator may preclude participation (e.g. Ehlers Danlos Syndrome) or interfere with completion of study follow-up
• •3. Subjects may not participate in any other clinical study that clinically interferes with this study while enrolled
• •4. Concomitant use of a synthetic or another biologic mesh
• •5. Subjects who require use of Permacol™ as only temporary closure with planned reoperation, or Permacol™ used as a temporary dressing in an open abdomen
• •6. Subject who has systemic sepsis at the time of Permacol™ implantation
• •7. Subject with ongoing necrotizing pancreatitis
• •8. Subject who requires use of Permacol™ in parastomal hernia repair alone, where there is no other anterior wall repair
• •9. Subject who requires prophylactic use of Permacol™ in the formation of stoma with anterior wall repair
• •10. Permacol™ used in pelvic floor reconstruction