Veritas in Non-Bridging Ventral Hernia Repair (VIBE)
|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|
|Primary Completion Date :||August 2017|
|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.
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|