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 ]

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.


Original Primary Outcome: Hernia recurrence [ Time Frame: 5 Years ]

Recurrence will be evaluated through physical exam and/or CT scans at all study visits (30 days, 6 months, 1 year, 2 years, 3 years, 4 years and 5 years), or when patients present with symptoms, with primary endpoint at 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