search
Back to results

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

Primary Purpose

Incisional Hernia

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Xen Matrix AB
Sponsored by
C. R. Bard
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Incisional Hernia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Keck Hospital of USC
  • California Pacific Medical Center - Sutter Health
  • Emory University
  • Massachusetts General Hospital
  • Brigham and Women's Hospital
  • Washington University
  • Duke University Medical Center
  • Ohio State University
  • Oregon Health & Science University
  • Trustees of the University of Pennsylvania
  • Texas Tech University Health Sciences Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Xen Matrix AB

Arm Description

Subjects treated with Xen Matrix AB

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
Number of Participants With Hernia Recurrence Within 6 Months and 24 Months of Implantation Procedure
Number of Participants With Reoperation Due to Index Hernia Repair
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.
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.
Number of Participants Who Returned to Work Post Implantation Procedure
Duration of Participants Stay in Hospital Following Implantation Procedure

Full Information

First Posted
February 22, 2016
Last Updated
September 24, 2021
Sponsor
C. R. Bard
search

1. Study Identification

Unique Protocol Identification Number
NCT02691962
Brief Title
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

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
May 2016 (undefined)
Primary Completion Date
May 2020 (Actual)
Study Completion Date
May 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
C. R. Bard

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Incisional Hernia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
75 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Xen Matrix AB
Arm Type
Experimental
Arm Description
Subjects treated with Xen Matrix AB
Intervention Type
Device
Intervention Name(s)
Xen Matrix AB
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number of Participants With Wound Occurrences Up to 45 Days Post Implantation
Description
Wound occurrences were defined as surgical site infection, seroma, wound dehiscence, skin necrosis and fistulas requiring intervention.
Time Frame
Up to 45 days post implantation
Secondary Outcome Measure Information:
Title
Number of Participants With Wound Occurrences > 45 Days Post Implantation
Description
Wound occurrences was defined as surgical site infection, seroma, wound dehiscence, skin necrosis and fistulas requiring intervention.
Time Frame
Day 45 and up to 2 years post implantation
Title
Number of Participants With Hernia Recurrence Within 6 Months and 24 Months of Implantation Procedure
Time Frame
Within 6 months and 24 months of implantation procedure
Title
Number of Participants With Reoperation Due to Index Hernia Repair
Time Frame
24 months post implantation procedure
Title
Total Score on the Carolinas Comfort Scale (CCS) at Baseline, 1, 3, 6, 12, 18, and 24 Months Post Implantation Procedure
Description
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.
Time Frame
Baseline, 1, 3, 6, 12, 18, and 24 months post implantation procedure
Title
General Health Score on the Short Form 12 (SF-12) Questionnaire at Baseline, 1, 3, 6, 12, 18, and 24 Months Post Implantation.
Description
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.
Time Frame
Baseline, 1, 3, 6, 12, 18, and 24 months post implantation
Title
Number of Participants Who Returned to Work Post Implantation Procedure
Time Frame
Up to 2 years following implantation procedure
Title
Duration of Participants Stay in Hospital Following Implantation Procedure
Time Frame
From index procedure day to discharge from hospital day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert Martindale, MD
Organizational Affiliation
Oregon Health and Science University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Keck Hospital of USC
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
California Pacific Medical Center - Sutter Health
City
San Francisco
State/Province
California
ZIP/Postal Code
94107
Country
United States
Facility Name
Emory University
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Brigham and Women's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Washington University
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63108
Country
United States
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Ohio State University
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
Oregon Health & Science University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Facility Name
Trustees of the University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Texas Tech University Health Sciences Center
City
El Paso
State/Province
Texas
ZIP/Postal Code
79430
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

We'll reach out to this number within 24 hrs