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

This study has been terminated.
(Sponsor decision, not safety related.)
Sponsor:
Information provided by (Responsible Party):
C. R. Bard
ClinicalTrials.gov Identifier:
NCT01305486
First received: December 22, 2010
Last updated: January 14, 2013
Last verified: January 2013
  Purpose

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.


Condition
Hernia

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Prospective, Multi-Center Study of Complex Ventral Hernia Repair Utilizing the XenMatrix™ Surgical Graft With Component Separation

Resource links provided by NLM:


Further study details as provided by C. R. Bard:

Primary Outcome Measures:
  • 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. [ Time Frame: 2 Years ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • To assess perioperative, short-term and long-term complications in subjects with complex hernias repaired with XenMatrix™ Surgical Graft and component separation. [ Time Frame: 2 Years ] [ Designated as safety issue: Yes ]
    Procedural and device related AEs collected from surgery until 24 months post surgery.

  • To assess the procedural time for XenMatrix™ Surgical Graft placement with component separation. [ Time Frame: Day 0 ] [ Designated as safety issue: No ]
    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).

  • To assess changes in subject quality of life (QOL) post repair with a XenMatrix™ Surgical Graft with component separation. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Changes in QOL will be assessed from baseline to 24 months utilizing the Short Form-36 (SF-36) version 2.

  • To assess clinical outcomes based on the tissue plane placement of the XenMatrix™ Surgical Graft. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    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.


Enrollment: 4
Study Start Date: September 2010
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01305486

Locations
United States, Louisiana
Our Lady of the Lake Regional Medical Center
Baton Rouge, Louisiana, United States, 70808
Sponsors and Collaborators
C. R. Bard
Investigators
Principal Investigator: Karl LeBlanc, MD Our Lady of the Lake Regional Medical Center
  More Information

No publications provided

Responsible Party: C. R. Bard
ClinicalTrials.gov Identifier: NCT01305486     History of Changes
Other Study ID Numbers: DVL-HE008
Study First Received: December 22, 2010
Last Updated: January 14, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Hernia
Hernia, Ventral
Pathological Conditions, Anatomical
Hernia, Abdominal

ClinicalTrials.gov processed this record on August 26, 2014