A Study of Complex Ventral Hernia Repair Utilizing the XenMatrix™ Surgical Graft With Component Separation (XenMatrix)

A Prospective, Multi-Center Study of Complex Ventral Hernia Repair Utilizing the XenMatrix™ Surgical Graft With Component Separation

This will be an observational study designed to collect early, short- and long-term clinical outcomes of the XenMatrix™ Surgical Graft for complex ventral hernia repair. Subjects will be expected to attend follow up visits at 1, 6, 12, 18 and 24 months following surgery.

Study Overview

• Status: Terminated
• Conditions: Hernia

• Study Type: Observational
• Enrollment (Actual): 4

Contacts and Locations

Study Locations

• United States
  • Louisiana
    • Baton Rouge, Louisiana, United States, 70808
      • Our Lady of the Lake Regional Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Subjects who are diagnosed with a ventral or incisional hernia that require a component separation repair with the use of a biological graft.

Description

Inclusion Criteria:

• Be able to undergo study procedures.
• Have signed an Informed Consent form (ICF).
• Be diagnosed with a ventral or incisional hernia that cannot be closed primarily in the opinion of the investigator.
• Requires a component separation repair with the use of a biological graft.

Exclusion Criteria:

• Subject is participating in another device or drug study.
• Subject has a life expectancy less than 4 years at the time of enrollment.
• Any condition in the opinion of the investigator that would preclude the use of the XenMatrix™ Surgical Graft, or preclude the subject from completing the follow-up requirements.
• Any subject with a defect the surgeon feels he/she cannot fully close.
• Subjects with a BMI > 50.
• Subjects with connective tissue disorders.
• Subjects with a history of cirrhosis.
• Subjects with renal failure requiring dialysis.
• Subjects on or suspected to be placed on chemotherapy or systemic immunosuppressive medications during any part of the study.
• Transplant recipients.
• Subjects taking corticosteroids for >6 months (pre or post surgery).
• Any bowel leak or infection that would preclude the use of the XenMatrix™ Surgical Graft in the opinion of the investigator.
• The subject lives approximately 2 hours away from the study site and compliance with follow up requirements will be difficult in the opinion of the investigator.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
XenMatrix

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To estimate the hernia recurrence rate of complex ventral hernias post repair with the XenMatrix™ Surgical Graft utilizing the component separation technique with several different tissue plane placements of the graft for up to 24 months post surgery.	Any hernia which is identified or confirmed by the investigator in approximately the same position as the hernia repair during any follow up visit after a XenMatrix™ surgical graft has been placed will be considered a recurrent hernia.	2 Years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To assess perioperative, short-term and long-term complications in subjects with complex hernias repaired with XenMatrix™ Surgical Graft and component separation.	Procedural and device related AEs collected from surgery until 24 months post surgery.	2 Years
To assess the procedural time for XenMatrix™ Surgical Graft placement with component separation.	Procedure time will be defined as beginning when the investigator makes the initial skin incision and ending when the skin closure is completed (skin to skin).	Day 0
To assess changes in subject quality of life (QOL) post repair with a XenMatrix™ Surgical Graft with component separation.	Changes in QOL will be assessed from baseline to 24 months utilizing the Short Form-36 (SF-36) version 2.	2 years
To assess clinical outcomes based on the tissue plane placement of the XenMatrix™ Surgical Graft.	Subjects who have their grafts placed in different tissue planes will have their recurrence rate, complication type and frequency examined to determine if there are any gross differences.	2 years

Collaborators and Investigators

• Sponsor: C. R. Bard
• Investigators: Principal Investigator: Karl LeBlanc, MD, Our Lady of the Lake Regional Medical Center

Study record dates

Study Major Dates

• Study Start: September 1, 2010
• Primary Completion (Actual): June 1, 2011
• Study Completion (Actual): June 1, 2011

Study Registration Dates

• First Submitted: December 22, 2010
• First Submitted That Met QC Criteria: February 25, 2011
• First Posted (Estimate): February 28, 2011

Study Record Updates

• Last Update Posted (Estimate): January 15, 2013
• Last Update Submitted That Met QC Criteria: January 14, 2013
• Last Verified: January 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Hernia, Abdominal; Hernia; Hernia, Ventral
• Other Study ID Numbers: DVL-HE008