Complex Ventral Hernia Repair Using Biologic or Synthetic Mesh

Exclusion Criteria

• •Lactating women
• •Patients who are unable to commit to the follow evaluations over 24 months
• •Severe malnutrition (serum albumin \<2.0 in the setting of a normal CRP)
• •Use of an investigational agent within 1 month prior to study enrollment and/or planned during this study
• •Presence of pre-existing parenchymal liver disease characterized by the presence of Child's Class C liver dysfunction (including all of the following: bilirubin ≥ 3.0 mg/dL; albumin ≤ 3.0 mg/dL; refractory ascites; encephalopathy or coma; and poor nutritional status)
• •Immunocompromised patients, as evidenced by: administration of high doses of corticosteroids (i.e. doses ≥ 1.5 mg/kg/day of prednisone or equivalent) within 72 hours before study enrollment; status post solid organ transplant or bone marrow transplant and experiencing acute organ rejection or bone marrow failure or rejection; evidence of neutropenia (absolute neutrophil count ≤ 500 cells/mm3 (≤ 500 x 106 cells/L); chemotherapy or radiation therapy within 90 days before study enrollment; known AIDS; any disease sufficiently advanced to suppress resistance to infection (including, but not limited to leukemia, lymphoma or hypogammaglobulinemia); administration of immunoglobulin of G-CSF within 90 days before study enrollment
• •Ascites refractory to medical management
• •Presence of an underlying disease/injury with life expectancy less than two years and/or severe underlying disease that would preclude study entry (e.g. known malignancy)
• •Wound Classification IV due to the presence/discovery of fecal peritonitis. Other cases of wound class IV including presence of purulent inflammation, soft tissue/mesh infection, or visceral perforation resulting in a contained fistula (e.g. enterocutaneous fistula) are still considered eligible for enrollment.