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

A Post-Market, Prospective, Multicenter, Single-Arm Trial of XenMatrix™ AB Surgical Graft in All Wound Classes Ventral or Incisional Midline Hernias

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.

Study Overview

• Status: Completed
• Conditions: Incisional Hernia
• Intervention / Treatment: Device: Xen Matrix AB

Detailed Description

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

• Study Type: Interventional
• Enrollment (Actual): 75
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90033
      • Keck Hospital of USC
    • San Francisco, California, United States, 94107
      • California Pacific Medical Center - Sutter Health
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Emory University
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Brigham and Women's Hospital
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital
  • Missouri
    • Saint Louis, Missouri, United States, 63108
      • Washington University
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Duke University Medical Center
  • Ohio
    • Columbus, Ohio, United States, 43210
      • Ohio State University
  • Oregon
    • Portland, Oregon, United States, 97239
      • Oregon Health & Science University
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Trustees of the University of Pennsylvania
  • Texas
    • El Paso, Texas, United States, 79430
      • Texas Tech University Health Sciences Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Xen Matrix AB; Subjects treated with Xen Matrix AB	Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Wound Occurrences Up to 45 Days Post Implantation	Wound occurrences were defined as surgical site infection, seroma, wound dehiscence, skin necrosis and fistulas requiring intervention.	Up to 45 days post implantation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Wound Occurrences > 45 Days Post Implantation	Wound occurrences was defined as surgical site infection, seroma, wound dehiscence, skin necrosis and fistulas requiring intervention.	Day 45 and up to 2 years post implantation
Number of Participants With Hernia Recurrence Within 6 Months and 24 Months of Implantation Procedure		Within 6 months and 24 months of implantation procedure
Number of Participants With Reoperation Due to Index Hernia Repair		24 months post implantation procedure
Total Score on the Carolinas Comfort Scale (CCS) at Baseline, 1, 3, 6, 12, 18, and 24 Months Post Implantation Procedure	The Carolinas Comfort Scale (CCS) quality of life questionnaire aimed for patients who have had hernia repair surgery. Symptoms in the CCS are rated by the participants on a scale of 0 to 5, with a score of 0 suggesting no symptoms and a score of 5, disabling symptoms. A lower score on the questionnaire compared to baseline would indicate a better outcome.	Baseline, 1, 3, 6, 12, 18, and 24 months post implantation procedure
General Health Score on the Short Form 12 (SF-12) Questionnaire at Baseline, 1, 3, 6, 12, 18, and 24 Months Post Implantation.	The Short Form 12 (SF-12) is a self-reported 12-item questionnaire that evaluates general health and well-being (overall quality of life of an individual). The SF-12 includes questions on physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. Scores range from 0 to 100, with higher scores indicating better levels of functioning.	Baseline, 1, 3, 6, 12, 18, and 24 months post implantation
Number of Participants Who Returned to Work Post Implantation Procedure		Up to 2 years following implantation procedure
Duration of Participants Stay in Hospital Following Implantation Procedure		From index procedure day to discharge from hospital day

Collaborators and Investigators

• Sponsor: C. R. Bard
• Investigators: Principal Investigator: Robert Martindale, MD, Oregon Health and Science University

Study record dates

Study Major Dates

• Study Start: May 1, 2016
• Primary Completion (Actual): May 1, 2020
• Study Completion (Actual): May 1, 2020

Study Registration Dates

• First Submitted: February 22, 2016
• First Submitted That Met QC Criteria: February 22, 2016
• First Posted (Estimate): February 25, 2016

Study Record Updates

• Last Update Posted (Actual): October 21, 2021
• Last Update Submitted That Met QC Criteria: September 24, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pathological Conditions, Anatomical; Hernia; Incisional Hernia
• Other Study ID Numbers: DVL-HE-012

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No