Antimicrobial Hernia Repair Device Clinical Study

Feasibility Study of the Antimicrobial Hernia Repair Device for Repair of Ventral or Incisional Hernia

This prospective clinical study will evaluate the safety and efficacy of the Cook® Antimicrobial Hernia Repair Device containing an antimicrobial to reinforce soft tissue during ventral or incisional hernia repair in clean-contaminated, contaminated, and dirty-infected (i.e., Class II, Class III, and Class IV) surgical fields. Up to 30 patients will be treated with the Cook® Antimicrobial Hernia Repair Device and patients will be followed for 12 months.

Inclusion Criteria:

• Patient presents with a ventral or incisional hernia that is to be surgically corrected using open repair technique

Exclusion Criteria:

• Body Mass Index (BMI) < 25.
• Body weight < 45 kg
• Glycosylated Hemoglobin (Hgb A1c) > 10%
• Albumin < 2.5 g/dL or pre-albumin < 5.0 mg/dL
• Renal insufficiency, as determined by an estimated glomerular filtration rate (GFR) < 60 mL/min/1.73 m2
• Known allergies to study device components
• Other relevant exclusion criteria apply