Clinical trial: RCT of Two Noncrosslinked Porcine Acellular Dermal Matrices in Ab Wall Reconstruction (NCT02228889)

Eligibility criteria:
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
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 99 Years

Patient description (medical language): A 49-year-old man comes to the office because of the bulging in his groin.  Physical examination shows a swelling above the inguinal ligament. When the patient is asked to cough, the size of the bulge increases.  His medical history is significant for mild dyslipidemia, which is under control by lifestyle modifications. He does not smoke, but drinks alcohol occasionally. His vital signs and other physical examinations are unremarkable. He is referred to a surgeon and scheduled to undergo elective laparoscopic hernia repair.

Patient description (patient's own words): I'm a 49-year-old man and I went to my doctor the other day because I could not stand that sharp pain in my upper thigh, it was so swollen! The doctor told me that it was swollen right next to my ligament. It's even bigger when I'm coughing. I'm suffering from high cholesterol and I already had to adapt my lifestyle to keep the disease under control. I do not smoke but to be honest I still drink from time to time. The doctor found my vitals normal. She gave me a note to see a surgeon to get my mass removed and get a hernia repair.

Does the patient match the trial criteria? 1