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

NCT01305486 | Terminated

• 1 other identifier: DVL-HE008
• Study Type: observational
• Target: 4
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hernia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• To assess perioperative, short-term and long-term complications in subjects with complex hernias repaired with XenMatrix™ Surgical Graft and component separation.

  2 Years

• To assess the procedural time for XenMatrix™ Surgical Graft placement with component separation.

  Day 0

• To assess changes in subject quality of life (QOL) post repair with a XenMatrix™ Surgical Graft with component separation.

  2 years

• To assess clinical outcomes based on the tissue plane placement of the XenMatrix™ Surgical Graft.

  2 years

Study Arms (1)

XenMatrix

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• C. R. Bard: lead

Study Sites (1)

Our Lady of the Lake Regional Medical Center

Baton Rouge, Louisiana, 70808, United States

Location

MeSH Terms

Conditions

Hernia

Condition Hierarchy (Ancestors)

Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Karl LeBlanc, MD

  Our Lady of the Lake Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 22, 2010
• First Posted: February 28, 2011
• Study Start: September 1, 2010
• Primary Completion: June 1, 2011
• Study Completion: June 1, 2011
• Last Updated: January 15, 2013

Record last verified: 2013-01

Locations

US (1)