Clinical trial NCT02691962: Xen Matrix™ AB Surgical Graft in Ventral or Incisional Midline Hernias
Official title: A Post-Market, Prospective, Multicenter, Single-Arm Trial of XenMatrix™ AB Surgical Graft in All Wound Classes Ventral or Incisional Midline Hernias
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Incisional Hernia
Lead sponsor: C. R. Bard
Sponsor class: INDUSTRY
First posted: 2016-02-25
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

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

Eligibility criteria: 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.

Primary outcomes:
measure: Number of Participants With Wound Occurrences Up to 45 Days Post Implantation
timeFrame: Up to 45 days post implantation
Secondary outcomes:
measure: Number of Participants With Wound Occurrences > 45 Days Post Implantation
timeFrame: Day 45 and up to 2 years post implantation
measure: Number of Participants With Hernia Recurrence Within 6 Months and 24 Months of Implantation Procedure
timeFrame: Within 6 months and 24 months of implantation procedure
measure: Number of Participants With Reoperation Due to Index Hernia Repair
timeFrame: 24 months post implantation procedure
measure: Total Score on the Carolinas Comfort Scale (CCS) at Baseline, 1, 3, 6, 12, 18, and 24 Months Post Implantation Procedure
timeFrame: Baseline, 1, 3, 6, 12, 18, and 24 months post implantation procedure
measure: General Health Score on the Short Form 12 (SF-12) Questionnaire at Baseline, 1, 3, 6, 12, 18, and 24 Months Post Implantation.
timeFrame: Baseline, 1, 3, 6, 12, 18, and 24 months post implantation
measure: Number of Participants Who Returned to Work Post Implantation Procedure
timeFrame: Up to 2 years following implantation procedure
measure: Duration of Participants Stay in Hospital Following Implantation Procedure
timeFrame: From index procedure day to discharge from hospital day
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Keck Hospital of USC
state: California
city: San Francisco
country: United States
facility: California Pacific Medical Center - Sutter Health
state: California
city: Atlanta
country: United States
facility: Emory University
state: Georgia
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
city: Saint Louis
country: United States
facility: Washington University
state: Missouri
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Columbus
country: United States
facility: Ohio State University
state: Ohio
city: Portland
country: United States
facility: Oregon Health & Science University
state: Oregon
city: Philadelphia
country: United States
facility: Trustees of the University of Pennsylvania
state: Pennsylvania
city: El Paso
country: United States
facility: Texas Tech University Health Sciences Center
state: Texas
Study officials:
affiliation: Oregon Health and Science University
name: Robert Martindale, MD
role: PRINCIPAL_INVESTIGATOR
References: