Complex Ventral Hernia Repair Using Biologic or Synthetic Mesh

This is a prospective, single-blind, randomized study comparing the clinical efficacy and
overall costs of two prosthetic meshes in the repair of complex ventral hernias. The two
prosthetic meshes to be studied are Ventralight (Bard, Murray Hill, NJ), a synthetic mesh
chiefly made of polypropylene and Strattice (LifeCell, Branchburg, NJ), a biologic mesh
derived from porcine dermis. The study population will consist of patients who are in need of
a repair of a complex ventral hernia. Patients will be enrolled in the study for 24 months
following their operation or until they experience a recurrence of their hernia, whichever
occurs first. The primary outcome variable is recurrence and the secondary outcome variables
are post-operative surgical site infections and overall costs.

There is no universally agreed upon definition of what constitutes a "complex" ventral
hernia. For our purposes, a "complex" ventral hernia is one that involves a compromised
surgical field, in which gastrointestinal, biliary, or genitourinary procedures are
performed, one in which the wound class is considered clean-contaminated, contaminated, or
dirty due to other causes, such as infected meshes and enterocutaneous fistulas, or surgical
procedures conducted in patients with large ventral hernia defects (>10 cm in any single
dimension).

Inclusion Criteria:

- Clinical evidence of a midline, ventral hernia, regardless of degree of wound
contamination, with the exception of class IV wounds due to the presence/discovery of
fecal peritonitis. Specifically, the repair will or will not involve a compromised
surgical field in which gastrointestinal, biliary and/or genitourinary procedures will
be performed. The surgical wound class may be classified as clean, or it may be
classified as clean-contaminated, contaminated, or dirty-infected, due to the repair
of an enterocutaneous fistula, takedown of an intestinal stoma and/or removal of
infected mesh

- Age >21

- Negative pregnancy test

- No allergic, religious or ethical objections to either polypropylene or porcine
prosthetics

- Signed, witnessed informed consent to take part in the study

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.