Multi-Center Study To Examine The Use Of Flex HD® And Strattice In The Repair Of Large Abdominal Wall Hernias

At least 100,000 ventral hernia repairs are performed in the U.S. each year. Recently,
biologically-based implants derived from acellular human dermis, porcine small intestinal
submucosa, and porcine dermis have been reported in a variety of complex abdominal wall
repair procedures. A variety of surgical techniques and implant placement methods have been
described, with no one standard technique achieving precedence. Biologic implant
reinforcement of a myofascial closure by means of component separation, or at a minimum,
where three-layer fascial approximation is not possible, sublay placement (i.e., closure of
the posterior rectus sheath under the implant) are described strategies. These techniques
allow placement of the implant against an intact fascial layer and may improve implant
incorporation into host tissue. However, the current literature shows few, if any,
prospective, randomized, head-to-head comparisons of human acellular dermal matrix (HADM)
allograft and porcine acellular dermal matrix (PADM) xenograft when used as a reinforcing
material in the repair of large abdominal hernias by a component separation technique.

The Musculoskeletal Transplant Foundation (MTF) has manufactured and processed Flex HD
Acellular Hydrated Dermis. This acellular dermis is derived from human skin. In complicated
ventral hernia repairs, this type of graft tissue is necessary. Flex HD has been shown to
reduce operative time, lower operative costs and provides minimal elasticity.

The primary objective of this study is to examine and compare the outcomes associated with
the use of Flex HD®, a human acellular dermal matrix (HADM), and Strattice™, a porcine
acellular dermal matrix, (PADM) when used as a reinforcing material in the repair of large
complicated abdominal wall hernias.

Inclusion Criteria:

- 18 years of age or greater

- Have a BMI <40

- Have a hernia of at least 200 cm^2

- Have no contraindications to 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 1 year post-operatively
(following research related surgery)

Exclusion Criteria:

- < 18 years of age

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

- Have a BMI > 40

- Have a hernia < 2002 cm

- 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 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 the 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 1 year
post-operative assessment period

- Subject's ventral hernia is related to an organ transplant surgery

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

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

- Uncontrolled diabetes (i.e. known HbA1C value > 7%)

- 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

- Undergoing concomitant panniculectomy

- Ventral hernia repairs involving actively infected mesh removal

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