The goal of this study is to evaluate safety and performance of the Fortiva Tissue Matrix. Participants will complete questionnaires to measure outcomes after hernia surgery for two years.
This is a post market, prospective, multi-center study of up to 120 participants at approximately 10 clinical study sites. Safety and performance will be measured after hernia repair for two years.
Study Type
OBSERVATIONAL
Enrollment
120
Acellular Dermal Matrix used in hernia surgery
James Paget University Hospital
Great Yarmouth, United Kingdom
Type of adverse events
Time frame: 6 weeks, 6 months, 12 months and 24 months
Patient satisfaction
SF-36 questionnaire has 8 multi-item scales with a higher score representing better health status. Each domain has a score range of 0-100
Time frame: 6 weeks, 6 months, 12 months and 24 months
Pain measured using the visual analog scale for pain
Visual Analog Scale using a scale of 0-10 with 0 being no pain and 10 being unbearable pain
Time frame: 6 weeks, 6 months, 12 months and 24 months
Implant failure
Partial or total removal of Fortiva Tissue Matrix
Time frame: 6 weeks, 6 months, 12 months and 24 months
Hernia recurrence
Hernia recurrence requiring surgical reintervention
Time frame: 12 months
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