A Comparison of Fortiva and Strattice Tissue Matrices in Complex, Ventral Hernia Repair

This is a randomized, prospective, double-blinded study evaluating the efficacy of Fortiva
Porcine Dermis versus Strattice Reconstructive Tissue Matrix in 120 patients with large
complex abdominal wall ventral hernias undergoing single stage repair. The patient will be
blinded to treatment as well as an independent qualified evaluator to confirm evidence of
reoccurrence. This post-market study compares two FDA cleared biologic hernia materials.
Fortiva™ porcine dermis, processed by RTI Surgical, Inc., a non-cross linked porcine dermis
will be compared to Strattice™ Reconstructive Tissue Matrix by Life Cell, a non-cross linked
porcine dermis for reinforcement during the single stage open reconstruction of abdominal
wall defects. The primary outcome will be hernia recurrence at 1 year. Outcomes will be
evaluated at 6 weeks, 3 months, 6 months and 12 months and 24 months.

Inclusion Criteria:

- 18 years of age or greater

- Have a BMI < or equal to 40

- Have a pre-operative estimated hernia defect of 200 cm2 OR multiple hernia defects
whose combined area is ≥ an estimated 200 cm2. Patients whose defects do NOT meet or
exceed 200 cm2 intra-operatively will be withdrawn from the study and will be
considered an intra-operative screen failure

- Have no contraindications to the test material (s)

- Have a life expectancy greater than 1 year in the opinion of the Investigator

- Able to provide informed consent

- Able and willing to return for scheduled study visits over 2 years post-operatively
(following research related surgery)

Exclusion Criteria:

- < 18 years of age

- Subject is determined to have an American Society of Anesthesiologists'(ASA) physical
class of 4, 5, or 6

- Have a BMI >40

- Have a hernia estimated to be <200 cm2

- Have abdominal loss of domain such that the operation would be impractical or would
adversely affect respiratory or cardiovascular function to an unacceptable degree in
the opinion of the investigator

- Inability to close the fascia primarily without abdominal wall mobilization or
component separation

- Participation in an investigational drug or device study that would impact the safety
or scientific integrity of this study (in the opinion of the Investigator and with the
approval of the Sponsor) within the past 6 weeks prior to enrollment into this trial

- Have active necrotizing fasciitis or any other known active local or systemic
infection

- Have a known collagen metabolism disorder or any medical condition that could
interfere with normal tissue healing process as determined by the Investigator

- Have a known active malignancy present and/or had chemotherapy 12 weeks prior to
screening or planned chemotherapy within 12 weeks of enrollment with exception of BCC
or SCC

- Have known moderate to severe cirrhosis which in the opinion of the Investigator would
impact the outcome of this trial

- Have a life expectancy less than 1 year

- Be unable to participate in the informed consent process

- Be unable or unwilling to return for scheduled study visits over the 2 year
post-operative assessment period

- Received high dose steroids (>/=100mg of prednisone) within the past 6 weeks

- Known tobacco use within the past 6 weeks or positive serum cotinine test at time of
admission

- Uncontrolled diabetes (i.e. known HbA1C value > 7% within the last 6 weeks)

- History of drug addiction (recreational drugs, prescription drugs or alcohol) that in
the Investigator's opinion may interfere with protocol assessments and/or the
subject's ability to complete the required follow up

- Pregnancy and/or breastfeeding

- Enterocutaneous fistula

- Ventral hernia repairs involving active infection

- Inability to obtain primary fascial closure (Intra-operatively)

- Planned use of external VAC dressing intra-operatively