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

NCT02691962 | Completed Results

• 1 other identifier: DVL-HE-012
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 11

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.

Conditions

Incisional Hernia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Number of Participants With Wound Occurrences > 45 Days Post Implantation

  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

  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.

  Baseline, 1, 3, 6, 12, 18, and 24 months post implantation

Study Arms (1)

Xen Matrix AB

EXPERIMENTAL

Subjects treated with Xen Matrix AB

Device: Xen Matrix AB

Interventions

Xen Matrix AB DEVICE

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.

Xen Matrix AB

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• C. R. Bard: lead

Study Sites (11)

Keck Hospital of USC

Los Angeles, California, 90033, United States

Location

California Pacific Medical Center - Sutter Health

San Francisco, California, 94107, United States

Location

Emory University

Atlanta, Georgia, 30322, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Washington University

St Louis, Missouri, 63108, United States

Location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

Ohio State University

Columbus, Ohio, 43210, United States

Location

Oregon Health & Science University

Portland, Oregon, 97239, United States

Location

Trustees of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Texas Tech University Health Sciences Center

El Paso, Texas, 79430, United States

Location

MeSH Terms

Conditions

Incisional Hernia

Condition Hierarchy (Ancestors)

Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Pathologic Processes

Results Point of Contact

• Title: Dawn Heimer
• Organization: Becton Dickinson and Company

Dawn.Heimer@bd.com

+1-401-825-8681

Study Officials

• Robert Martindale, MD

  Oregon Health and Science University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 22, 2016
• First Posted: February 25, 2016
• Study Start: May 1, 2016
• Primary Completion: May 1, 2020
• Study Completion: May 1, 2020
• Last Updated: October 21, 2021
• Results First Posted: October 21, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (11)