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

Hernia Clinical Trial

— XenMatrix  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01305486
• Other study ID #: DVL-HE008
• Status: Terminated
• Phase: N/A
• First received: December 22, 2010
• Last updated: January 14, 2013
• Start date: September 2010
• Est. completion date: June 2011

Study information

• Verified date: January 2013
• Source: C. R. Bard
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 4
• Est. completion date: June 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Hernia
• Hernia, Ventral

Locations

Country	Name	City	State
United States	Our Lady of the Lake Regional Medical Center	Baton Rouge	Louisiana

Sponsors (1)

Lead Sponsor	Collaborator
C. R. Bard

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	Yes
Secondary	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	No
Secondary	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	No
Secondary	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	No