Xen Matrix™ AB Surgical Graft in Ventral or Incisional Midline Hernias
NCT ID: NCT02691962
Last Updated: 2021-10-21
Study Results
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View full resultsBasic Information
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COMPLETED
NA
75 participants
INTERVENTIONAL
2016-05-31
2020-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Xen Matrix AB
Subjects treated with Xen Matrix AB
Xen Matrix AB
Xen Matrix™ AB Surgical Graft is an acellular, sterile, non-pyrogenic porcine dermal matrix packed dry for use in the reconstruction of soft tissue deficiencies. The device surfaces are coated with the antibacterial agents Rifampin and Minocycline in a bioresorbable L-Tyrosine succinate polymer carrier.
Interventions
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Xen Matrix AB
Xen Matrix™ AB Surgical Graft is an acellular, sterile, non-pyrogenic porcine dermal matrix packed dry for use in the reconstruction of soft tissue deficiencies. The device surfaces are coated with the antibacterial agents Rifampin and Minocycline in a bioresorbable L-Tyrosine succinate polymer carrier.
Eligibility Criteria
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Inclusion Criteria
* 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 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.
18 Years
ALL
No
Sponsors
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C. R. Bard
INDUSTRY
Responsible Party
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Principal Investigators
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Robert Martindale, MD
Role: PRINCIPAL_INVESTIGATOR
Oregon Health and Science University
Locations
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Keck Hospital of USC
Los Angeles, California, United States
California Pacific Medical Center - Sutter Health
San Francisco, California, United States
Emory University
Atlanta, Georgia, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Brigham and Women's Hospital
Boston, Massachusetts, United States
Washington University
St Louis, Missouri, United States
Duke University Medical Center
Durham, North Carolina, United States
Ohio State University
Columbus, Ohio, United States
Oregon Health & Science University
Portland, Oregon, United States
Trustees of the University of Pennsylvania
Philadelphia, Pennsylvania, United States
Texas Tech University Health Sciences Center
El Paso, Texas, United States
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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DVL-HE-012
Identifier Type: -
Identifier Source: org_study_id