Clinical Trial: Veritas in Non-Bridging Ventral Hernia Repair
Study Status: Terminated
Recruit Status: Terminated
Study Type: Observational
Official Title: Veritas in Non-Bridging Ventral Hernia Repair
Brief Summary: The main study objective is to determine the frequency of hernia recurrence following use of Veritas Collagen Matrix.
Detailed Summary:
Sponsor: Baxter Healthcare Corporation
Current Primary Outcome: Hernia recurrence [ Time Frame: 2 Years ]
Original Primary Outcome: Hernia recurrence [ Time Frame: 5 Years ]
Current Secondary Outcome:
- 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.
Original Secondary Outcome:
- Number of Medical and Surgical Complications [ Time Frame: 5 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, 2 years, 3 years, 4 years and 5 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 5 Years ]Patients will complete questionnaires regarding physical functioning including activities of daily living, work productivity, and patient comfort at vartious timepoints after implant at baseline, and at all follow-up visits. Outcomes will be reported in the change from baseline to 5-years.
Information By: Baxter Healthcare Corporation
Dates:
Date Received: August 29, 2011
Date Started: August 2011
Date Completion: August 2017
Last Updated: April 4, 2017
Last Verified: April 2017