Veritas in Non-Bridging Ventral Hernia Repair (VIBE)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01426477|
Recruitment Status : Terminated
First Posted : August 31, 2011
Last Update Posted : January 23, 2018
|Condition or disease|
|Study Type :||Observational|
|Actual Enrollment :||20 participants|
|Official Title:||Veritas in Non-Bridging Ventral Hernia Repair|
|Study Start Date :||August 2011|
|Actual Primary Completion Date :||August 2017|
|Actual Study Completion Date :||August 2017|
Veritas Collagen Matrix
Observational study of subjects who undergo open ventral hernia repair using Veritas Collagen Matrix in an underlay technique.
- Hernia recurrence [ Time Frame: 2 Years ]Recurrence will be evaluated through physical exam and/or CT scans at all study visits (30 days, 6 months, 1 year, and 2 years), or when patients present with symptoms, with primary endpoint at 2 years.
- Number of Medical and Surgical Complications [ Time Frame: 2 years ]Medical and Surgical Complications, including seroma, wound infection or other concurrent infection, hematoma, fistula, ileus, skin necrosis, wound dehiscence, or any other device-related events, will be evaluated through physical exam and/or CT scans at 30 days, 6 months, 1 year, and 2 years, or when patients present with symptoms. These will be reported as total number of each complication within the total number of patients.
- Change in Quality of Life [ Time Frame: Baseline to 2 Years ]Patients will complete questionnaires regarding physical functioning including activities of daily living, work productivity, and patient comfort at various timepoints after implant at baseline, and at all follow-up visits. Outcomes will be reported in the change from baseline to 2-years.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01426477
|United States, Florida|
|Mayo Clinic Department of Surgery|
|Jacksonville, Florida, United States, 32224|
|Watson Clinic Center for Research|
|Lakeland, Florida, United States, 33805|
|United States, Georgia|
|Atlanta Colon & Rectal Surgery, P.A.|
|Atlanta, Georgia, United States, 30274|
|United States, Virginia|
|Pratt Medical Center|
|Fredericksburg, Virginia, United States, 22407|