Clinical trial NCT01305486: A Study of Complex Ventral Hernia Repair Utilizing the XenMatrix™ Surgical Graft With Component Separation
Official title: A Prospective, Multi-Center Study of Complex Ventral Hernia Repair Utilizing the XenMatrix™ Surgical Graft With Component Separation
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Hernia
Lead sponsor: C. R. Bard
Sponsor class: INDUSTRY
First posted: 2011-02-28
Enrollment: 4
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


Eligibility 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.

Primary outcomes:
measure: 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.
timeFrame: 2 Years
Secondary outcomes:
measure: To assess perioperative, short-term and long-term complications in subjects with complex hernias repaired with XenMatrix™ Surgical Graft and component separation.
timeFrame: 2 Years
measure: To assess the procedural time for XenMatrix™ Surgical Graft placement with component separation.
timeFrame: Day 0
measure: To assess changes in subject quality of life (QOL) post repair with a XenMatrix™ Surgical Graft with component separation.
timeFrame: 2 years
measure: To assess clinical outcomes based on the tissue plane placement of the XenMatrix™ Surgical Graft.
timeFrame: 2 years
Other outcomes:
Locations:
city: Baton Rouge
country: United States
facility: Our Lady of the Lake Regional Medical Center
state: Louisiana
Study officials:
affiliation: Our Lady of the Lake Hospital
name: Karl LeBlanc, MD
role: PRINCIPAL_INVESTIGATOR
References: