Feasibility of Permacol Use in Infected Fields
Condition: Hernia
MeSH terms: Hernia
Intervention: acellular porcine dermal collagen mesh
Intervention description: porcine mesh for hernia repair/ abdominal wall reconstruction
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 10.0
Sex: All
Minimum age: 18 Years
Maximum age: 85 Years
Healthy volunteers: No
Keywords: Hernia; Contaminated Field; Mesh Removal; infected mesh removal

Summary:

      This pilot study is to examine the feasibility of using Permacol Surgical Implant in the
      repair of abdominal wall defects after removal of infected prosthetic mesh
    

Eligibility criteria:

        Inclusion Criteria:

          -  Have given written Informed Consent

          -  Be 18-85 years of age (inclusive)

          -  Have prosthetic mesh that is in proximity to an infected wound that has failed
             conservative management for at least 3 months, with mesh exposure and a draining
             wound, or that is in proximity to an abscess that requires operative intervention.

          -  Have a wound characterized by purulent discharge, positive gram stain or positive
             culture to document infection

          -  Be a candidate for surgical removal of infected mesh placed for repair of
             ventral/incisional hernias and concomitant abdominal wall reconstruction

          -  Have an ASA Score ≤3

          -  Have a body mass index (BMI) between 16.5 and 40 inclusive

          -  Be a candidate for anticipated primary approximation of skin/wound

          -  Have a life expectancy of at least 18 months

          -  Be willing to allow biopsy of implant if secondary wound opening is performed or
             spontaneous implant exposure occurs

        Exclusion Criteria:

          -  Have loss of abdominal domain such that the operation would be impractical or would
             adversely effect respiratory or cardiovascular function to an unacceptable degree

          -  Have an enterocutaneous fistula in proximity to wound/mesh

          -  Be a candidate for emergency surgery that would make giving valid Informed Consent
             impractical

          -  Be currently taking part in another clinical study that conflicts with the current
             study

          -  Have known allergy to porcine collagen products

          -  Have active generalized peritonitis or intraperitoneal sepsis

          -  Have active necrotizing fasciitis

          -  Have active abdominal compartment syndrome

          -  Have active untreated metabolic or systemic illness

          -  Report unintentional weight loss >10% of body weight in the previous 90 days

          -  Have known collagen metabolism disorder.(e.g., Ehlers-Danlos syndrome)

          -  Have known altered immune response (e.g., HIV or other immunodeficiency disorder))

          -  Have chronic renal failure

          -  Have known active malignancy present

          -  Have history of systemic chemotherapy within previous 1 year

          -  Have lifetime history of radiation to the abdomen, pelvis or thorax

          -  Have inguinal or groin hernia as primary diagnosis

          -  Be currently pregnant or planning to become pregnant during study period

          -  Be unable to give valid informed consent or comply with required follow- up schedule

          -  Suffer from mental capacity sufficiently severe to make informed consent unobtainable