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

Stopped early

Conditions studied: Hernia

In brief

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.

Key facts

Study ID

NCT01305486

Run by

C. R. Bard

People needed

4

Starts

2010-09-01

Expected to finish

2011-06-01

Last updated by the study team

2013-01-15

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

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

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.