Status:
TERMINATED
The Use of Biologic Mesh vs Bioabsorbable Mesh During Ventral Hernia Repair in At-risk Patients
Lead Sponsor:
Wake Forest University Health Sciences
Conditions:
Ventral Hernia
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
This study evaluates the outcomes of patients who have been treated with Strattice or Gore Bio-A mesh for the repair of complicated abdominal wall hernias. The purpose of this study is to collect info...
Detailed Description
The goal of the proposed study is to evaluate the outcomes of patients implanted with Strattice® (LifeCell Corporation, Branchburg, NJ, USA) and Gore® Bio-A® (W. L. Gore \& Associates, Inc., Newark, D...
Eligibility Criteria
Inclusion
- Age 18 or older
- Grade II or III ventral hernia according to Ventral Hernia Working Group (VHWG)
- Pre-operative informed consent is obtainable
Exclusion
- Return to the operating room within the next 1 year for additional open abdominal surgery is anticipated
- Absence of fascial defect or fascial defect less than 3 cm in greatest dimension
- Presence of previously place mesh (synthetic or biologic) at the site of surgery, which will not be completely removed and will, in part or whole, remain at the site of implantation of the study mesh
- Concurrent placement of another mesh (synthetic or biologic) at the site where the study mesh is placed
- Grade IV ventral hernia according to VHWG system
- ASA score IV or above
- Any disease or condition along with the surgeon's clinical judgment that contraindicates the use of either study mesh
- Pregnancy
Key Trial Info
Start Date :
November 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 21 2017
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT01794338
Start Date
November 1 2012
End Date
July 21 2017
Last Update
August 15 2022
Active Locations (1)
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1
Atrium Health - Carolinas Medical Center
Charlotte, North Carolina, United States, 28204