Biologic Mesh Versus Synthetic Mesh in Repair of Ventral Hernias

This is a multicenter prospective double-blinded randomized controlled trial comparing 253
patients with clean-contaminated (Class 2)or contaminated (Class3) abdominal wall ventral
hernias undergoing single staged repair. Soft Mesh by CR Bard, a macroporous monofilament
polypropylene permanent mesh will be compared to Strattice mesh by Lifecell, a non-cross
linked porcine dermal biologic graft for the single stage open reconstruction of
clean-contaminated and contaminated abdominal wall defects. The primary outcome variable
will be the absence of surgical site occurence requiring procedural intervention and the
absence of a hernia recurrence from the time of surgery up to 24 months of postoperative
follow up.

Patients undergoing open ventral hernia repair for clean-contamination and contaminated
abdominal wall hernias meeting inclusion criteria will be randomized to receive a synthetic
mesh or a biologic mesh. Randomization will be carried out using computer-generated
randomization blocks at the time of enrollment. Stratified randomized will be used with the
strata formulated by medical center then by clean-contaminated or contaminated surgical site
class. The Investigator will be blinded to patient randomization assignment until the point
of intra-operative device use following final CDC wound classification, whereas patients and
co-investigators responsible for data analysis will remain blinded to patient randomization
until the conclusion of the study period. As such, a double-blinded study protocol will be
maintained. Patients randomized to synthetic mesh will receive SoftMesh™ (CR Bard, Murray
Hill, NJ) and those patients randomized to biologic mesh will receive Strattice™ (Lifecell,
Branchburg NJ). The use of biologic and synthetic mesh in contaminated fields is considered
experimental however the selection of these prosthetics was based on a careful review of the
multiple animal models, preclinical data, and our own clinical experience with each of these
materials placed in both clean and contaminated abdominal wall reconstructions. Surgical
wounds will be classified based on CDC(Centers for Disease Control) criteria and only Class
2 and 3 wounds will be included in this study.

Postoperatively patients will be evaluated for signs and symptoms of complications along
with presence or absence of Surgical Site Infections per CDC guidelines, presence or absence
of surgical site occurrences (SSOs) and any procedural interventions required to treat these
SSOs, presence or absence of hernia recurrence and any reoperations, length of hospital
stay, discharge date, time to return of bowel function and any readmission.

Active participation in this study will last for 24 months and will involve one preoperative
evaluation visit, one operative procedure visit, and 4 follow up visits. Participants will
complete two brief survey questionnaires regarding quality of life, activities and pain.

The second outcome will be to demonstrate that a macroporous light-weight polypropylene mesh
is more cost effective strategy than a biologic prosthetic in clean-contaminated and
contaminated abdominal wall reconstruction.

Inclusion Criteria:

1. The subject is > 21 years of age (including women of childbearing age)

2. Scheduled to undergo a planned open single stage reconstruction of a contaminated
(CDC wound class2 or 3) abdominal wall defect

3. Ability to undergo general anesthesia

4. Is willing and able to give informed consent

5. Is this a clean-contaminated (Class 2) or contaminated (Class 3) case per CDC
Guidelines?

6. Has an estimated parastomal hernia or midline defect size of >9 cm 2 contaminated
(CDC wound class 2 or 3) abdominal wall defect by physical /or radiological exam.

7. Can achieve midline fascial closure?

8. Is subject willing to return for scheduled and required study visits?

Exclusion Criteria:

1. Patients have a defect that the surgeon cannot achieve primary fascial apposition and
requires a bridge of mesh.

2. Is the patients BMI over 45 kg/m2?

3. Is the patient currently pregnant?

4. Will undergo a laparoscopic or robotic hernia repair.

5. Do they have a class 1 or 4 wound per CDC Guidelines?

6. Are they on immunosuppression including medically-induced with>10 mg of
prednisone/day?

7. Do they have a collagen vascular disorder?

8. Is patient having a prior mesh removed due to a current active mesh infection? (A
synthetic mesh that is not incorporated into the tissue, is extracorporeally exposed
or has a chronic draining sinus with clear fluid around the material, but not
including synthetic mesh incorporated in abdominal wall and not infected)

9. Does the patient have Ascites refractory to medical management?

10. Are they in end stage renal (on hemodialysis or peritoneal dialysis) or pre-existing
liver disease (Hepatitis B or C or Total Bilirubin >3.0mg/dl)?

11. Is the patient severely malnourished as defined by serum albumin<2.0g/dl?

12. Do they have a smoking history within 1 month of surgery?

13. Does the patient have an objection to the implantation of porcine products?

14. Is the subject participating in another clinical study?

15. Are unable to undergo successful retro-rectus/preperitoneal mesh placement