Clinical trial: A Prospective Case Series Evaluating Surgimend Mp® In Patients Undergoing Complex Abdominal Hernia Repair (NCT03450473)

Eligibility criteria:
Inclusion Criteria:

          1. Men or women ≥ 18 years of age and able to give their own consent.

          2. The subject is able and willing to comply with study procedures and a signed and dated
             informed consent is obtained.

          3. The subject has a complex ventral hernia

          4. The surgeon intends to use bioprosthetic mesh in the repair of the hernia

          5. The hernia meets the definition of complex.

             For this study a hernia defect will be considered complex if:

             5.1. a hernia defect is large enough to require component separation to achieve
             midline fascial closure under physiologic tension 5.2. or the surgical wound is class
             II -potentially contaminated or class III - contaminated without signs of infection as
             defined by the CDC wound classification (see Table 1) 5.3. or a patient classified as
             at risk for surgical site complications by having 2 or more of the following
             comorbidities:

               -  Current smoker or recent history of smoking

               -  Obesity (BMI ≥ 30)

               -  Type I or Type II diabetes

               -  Chronic Obstructive Pulmonary Disease (COPD)

               -  Poor nutritional status as judged by the Investigator

               -  Current immunosuppressive therapy

               -  Current and/or recent (within 30 days of planned surgery) Corticosteriod use

               -  Prior Mesh infection

          6. Life expectancy of the patient is considered by the physician to be greater than at
             least 1 year

          7. The subject has no known hypersensitivity to bovine collagen

          8. The subject has no obvious condition interfering with their ability to comply with the
             treatment regimen

          9. The subject is willing and capable of returning for all follow-up evaluations, in the
             opinion of the treating physician

        Exclusion Criteria:

        Pre-Operative Exclusion:

          1. < 18 years of age

          2. 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

          3. Participation in an investigational drug or device study within the past 6 weeks prior
             to enrollment into this trial

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

        Intra-Operative Exclusion Criteria:

        Subjects will be excluded from the study after the index operation if any of the following
        exclusion criteria are met:

          1. Primary closure of the skin and subcutaneous tissue is not achieved at the index
             operation

          2. Bioprosthetic mesh was not used in the repair for any reason

          3. Primary Fascial closure unable to be obtained i.e. bridged closure

          4. Unable to place the mesh in the retrorectus space (no intraperitoneal placement)
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.


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? Contradiction