A Post-Market, Prospective, Multicenter, Single-Arm Trial of XenMatrix™ AB Surgical Graft in All CDC Wound Class Ventral or Incisional Midline Hernias
Description
Phase
N/AInclusion and Exclusion Criteria
- Subject must be willing and able to give written informed consent.
- Subject must be diagnosed with a ventral or incisional midline hernia.
- Mesh must be placed in the retro-rectus or intraperitoneal plane.
- Subject must be willing to undergo open hernia repair and be able to undergo all other study procedures as outlined in this protocol.
- The use of surgical graft as a bridge repair.
- The subject has more than 4 prior recurrences.
- Subject has a contraindication for the placement of surgical graft.
- Complete removal of existing mesh from a prior hernia repair (in the same affected area) is not possible.
- The study hernia repair requires more than a single piece mesh (including sufficient overlap beyond margins of the defect on all sides). Subject has intact permanent mesh adjacent to the current hernia to be repaired.
- Subject has peritonitis at the time of surgery.
- The subject is an active smoker within the last 2 weeks prior to surgery.
- Clinically significant COPD or heart failure, defined as marked limitation in ability or inability to perform activities of daily living.
- Subject had chemotherapy within the last 12 months, is on or suspected to be placed on chemotherapy medications during any part of the study.
- Chronic steroid use (>6 months) or immunosuppression drugs.
- Subject's body mass index (BMI) >40 kg/m2.
- Subject has cirrhosis, and/or ascites.
- Subject has a defined collagen disorder.
- Known to be infected with human immunodeficiency virus (HIV).
- Subject has clinically significant (not based solely on creatinine levels) kidney disease that limits ADL, is on hemodialysis or peritoneal dialysis.
- Subject is American Society of Anesthesiology (ASA) Class 4 or 5.
- Subject has a life expectancy < 2 years at the time of enrollment.
- Subject is pregnant, breastfeeding or planning on becoming pregnant during the course of the study.
- Subjects with known sensitivity to porcine products.
- Subjects with allergy, history of allergy or hypersensitivity to tetracyclines (including minocycline) or rifamycins (including rifampin).
- Subject has any condition in the opinion of the Investigator that would preclude the use of the study device, or preclude the subject from completing the follow-up requirements.
Sites
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