RCT of Two Noncrosslinked Porcine Acellular Dermal Matrices in Ab Wall Reconstruction
RCT of Two Noncrosslinked Porcine Acellular Dermal Matrices in Ab Wall Reconstruction
The purpose of the study is to compare the clinical outcomes of two commonly used,
 FDA-approved biologic meshes in hernia repair and abdominal wall reconstruction (Strattice
 and XenMatrix). The two meshes are derived from pig skin from which cells have been removed
 and which have been sterilized. The two meshes are made by two different companies using
 different processes.
This is a prospective, randomized-controlled trial comparing two porcine acellular matrices
 in abdominal wall reconstruction. It is single-blind (patients are blinded to the type of
 mesh used while surgeons are not).

 Our goals in this study are:

 1. PRIMARY OUTCOME: To compare the overall complication rates between two non-cross-linked
 porcine dermal matrices (XenMatrix and Strattice) at 30 days and 1 year postoperatively

 2. SECONDARY OUTCOMES

 i. To compare the rate of Surgical Site Occurrences (SSOs) between XenMatrix and Strattice in
 abdominal wall reconstruction at 30 days and 1 year postoperatively

 1. Infection

 2. Seroma

 3. Hematoma

 4. Wound dehiscence

 5. Skin necrosis

 6. Formation of enterocutaneous fistula

 7. Mesh infection ii. To compare the hernia recurrence rate between XenMatrix and Strattice
 at 30 days and 1 year postoperatively iii. To compare the bulge rate between XenMatrix
 and Strattice at 30 days and 1 year postoperatively iv. To compare to changes in patient
 pain, physical functioning and quality of life after hernia repair between XenMatrix and
 Strattice, preoperatively, and at 1 year postoperatively A. Pain assessment: Patient
 Reported Outcomes Measurement Information System (PROMIS) Pain Intensity survey, PROMIS
 Pain Interference survey B. Physical functioning assessment: PROMIS Physical Function C.
 Quality of life assessment: Hernia-Related Quality-of-Life (HerQLes) survey
Inclusion Criteria:

 -  Age > 18

 -  Patients presenting for elective hernia repair, with Ventral Hernia Working Group
 (VHWG) grade 2 or above (Patients with a hernia who need hernia repair due to hernia
 size, discomfort, risk of bowel incarceration, effect on physical function), and who
 have comorbidities or contamination making the use of synthetic mesh contraindicated)

 -  Patients deemed to be good surgical candidates, with no active life-threatening
 cardiac disease, pulmonary disease, renal disease, hematologic disease (patients who
 can have a major surgical procedure without an exceedingly high risk of medical
 complications such as pulmonary edema, myocardial infarction, pulmonary embolism,
 renal failure, life-threatening bleeding, stroke).

 -  Patients presenting for resection of large abdominal wall tumors who are expected to
 undergo have tumor extirpative defect that would require biologic mesh for closure
 (patients with a large tumor of the abdominal wall who will have a large defect in
 their fascia after resection, who need biologic mesh for reinforcement).

 Exclusion Criteria:

 -  Known allergy to porcine products

 -  Active smokers (within the past 4 weeks) presenting for elective hernia repair

 -  Patients with active life-threatening cardiac disease, pulmonary disease, renal
 disease, hematologic disease presenting for elective hernia repair

 -  Patients presenting for emergent hernia repair (in the setting of bowel strangulation,
 necrosis, penetrating trauma) as it will be difficult to consent those patients for
 the study preoperatively

 -  Patients with severe systemic sepsis

 -  Patients with frank purulence in the wound