Xen Matrix™ AB Surgical Graft in Ventral or Incisional Midline Hernias

C. R. Bard

Status

Completed

Conditions

Incisional Hernia

Treatments

Device: Xen Matrix AB

Study type

Interventional

Funder types

Industry

Identifiers

NCT02691962

DVL-HE-012

Details and patient eligibility

About

This study aims to prospectively explore the use of XenMatrix™ AB Surgical Graft for ventral or incisional midline hernia repair in patients across all wound classes ("All Comers") through 24 months post repair.

Full description

This is a post-market, on-label study to understand the performance of the graft in the US.

Enrollment

75 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion 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.

Exclusion criteria

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 Chronic Obstructive Pulmonary Disease 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) >45 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 Activities of Daily Living, 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.