Incisional HerniaNCT02691962

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

A study testing Xen Matrix AB in people with Incisional Hernia, run by C. R. Bard at 11 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Incisional Hernia
What is being tested?: Xen Matrix AB
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 75 participants
Where: 11 sitesUnited States
Study dates: May 2016to May 2020
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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.

Show all 22Show fewer

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.

Trial locations and contacts

11 sites in 1 country.

City, postcode or hospital

11 sites in 1 country

United States11 sites

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

Other trials in United States

About this study

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

Read the detailed description

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

Conditions: Incisional Hernia
Being tested: Xen Matrix AB
Medical subject headings: Incisional Hernia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Xen Matrix ABDevice
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.

Study groups in NCT02691962
Study group	Role	What they receive
Xen Matrix AB	Experimental	Subjects treated with Xen Matrix AB Receives: Device: Xen Matrix AB

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Up to 45 days post implantation

Secondary outcomes (7)

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.
Measured: Day 45 and up to 2 years post implantation
Number of Participants With Hernia Recurrence Within 6 Months and 24 Months of Implantation Procedure
Measured: Within 6 months and 24 months of implantation procedure
Number of Participants With Reoperation Due to Index Hernia Repair
Measured: 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.
Measured: 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.
Measured: Baseline, 1, 3, 6, 12, 18, and 24 months post implantation
Number of Participants Who Returned to Work Post Implantation Procedure
Measured: Up to 2 years following implantation procedure
Duration of Participants Stay in Hospital Following Implantation Procedure
Measured: From index procedure day to discharge from hospital day

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

May 2016May 2020

First posted25 Feb 2016 (estimated)
Study startMay 2016
Primary completionMay 2020
Study completionMay 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Incisional HerniaStudies of the same condition, open and under way.
More trials run by C. R. BardThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 75 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02691962
Sponsor's protocol ID: DVL-HE-012
Status last verified: Sep 2021
First submitted: 22 Feb 2016
Last updated: 21 Oct 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruitingObservational study
Pilot Study on the Effectiveness and Safety of OPTILENE® SILVER MESH ELASTIC in Prevention of Surgical Site Infection (SSI) and Incisional Hernia (IH)
Abdominal Aortic Aneurysm, Morbid Obesity
Active, not recruitingObservational study
Assessment of GORE® SYNECOR Biomaterial in Focused Patient Populations and Long-Term Application
Hernia, Ventral, Hernia Incisional
Not yet recruiting
Suture Choice for Ostomy Creation
Ostomy - Ileostomy or Colostomy, Stoma Complications
RecruitingObservational study
Patient-Specific Biomechanical Modeling of Incisional Hernias Using Artificial Intelligence and Finite Element Analysis
Incisional Hernia
Recruiting
GORE® ENFORM Biomaterial Product Study
Hernia, Ventral, Hernia, Hiatal

All Incisional Hernia trials

Study at a glance

From the registry record, last updated by the sponsor on 21 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Post-Market, Prospective, Multicenter, Single-Arm Trial of XenMatrix™ AB Surgical Graft in All Wound Classes Ventral or Incisional Midline Hernias
ClinicalTrials.gov ID: NCT02691962
Acronym / sponsor ID: DVL-HE-012
Conditions: Incisional Hernia
Study type: Interventional
Recruitment status: Completed
Enrolment: 75 participants (actual)
Lead sponsor: C. R. BardIndustry (pharma, biotech, devices)
Study start: May 2016
Primary completion: May 2020 (actual)
Study completion: May 2020 (actual)
First posted: 25 Feb 2016 (estimated)
Results: Posted 21 Oct 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

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

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Xen Matrix AB	Experimental	Device: Xen Matrix ABSubjects treated with Xen Matrix AB

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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.

Key exclusion criteria (22 listed)

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).

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Xen Matrix ABXen 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.	Device	Xen Matrix AB

Primary outcome

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

7 secondary outcomes

Number of Participants With Wound Occurrences > 45 Days Post Implantation
Time frame: Day 45 and up to 2 years post implantation
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
Number of Participants With Reoperation Due to Index Hernia Repair
Time frame: 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
Time frame: 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.
Time frame: Baseline, 1, 3, 6, 12, 18, and 24 months post implantation
Number of Participants Who Returned to Work Post Implantation Procedure
Time frame: Up to 2 years following implantation procedure
Duration of Participants Stay in Hospital Following Implantation Procedure
Time frame: From index procedure day to discharge from hospital day

Results and safety

Results posted to the registry on 21 Oct 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Subjects Treated With Xen Matrix AB	75	59

Primary outcome: Number of Participants With Wound Occurrences Up to 45 Days Post Implantation

Time frame: Up to 45 days post implantation. Count of participants. Unit: Participants

Measure	Xen Matrix AB n = 75
Value	11

Population analysed: The primary endpoint was wound occurrence within 45 days post implantation that required intervention.

7 secondary outcomes are reported in the full results.

Adverse events

Time frame: From Day of index procedure up to 24 months post implantation procedure.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Subjects Treated With Xen Matrix AB	31 of 75 (41.3%)	55 of 75 (73.3%)	1 of 75

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Incisional Hernia

Not yet recruitingObservational study
Pilot Study on the Effectiveness and Safety of OPTILENE® SILVER MESH ELASTIC in Prevention of Surgical Site Infection (SSI) and Incisional Hernia (IH)
Abdominal Aortic Aneurysm, Morbid Obesity
Active, not recruitingObservational study
Assessment of GORE® SYNECOR Biomaterial in Focused Patient Populations and Long-Term Application
Hernia, Ventral, Hernia Incisional
Not yet recruiting
Suture Choice for Ostomy Creation
Ostomy - Ileostomy or Colostomy, Stoma Complications
RecruitingObservational study
Patient-Specific Biomechanical Modeling of Incisional Hernias Using Artificial Intelligence and Finite Element Analysis
Incisional Hernia
Recruiting
GORE® ENFORM Biomaterial Product Study
Hernia, Ventral, Hernia, Hiatal

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Robert Martindale, MD principal investigator

Oregon Health and Science University

11 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Xen Matrix AB in people with Incisional Hernia, run by C. R. Bard at 11 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 11 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 21 Oct 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Wound Occurrences Up to 45 Days Post Implantation (time frame: Up to 45 days post implantation). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02691962.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2021.