Abdominal Wall Reconstruction, Incisional Hernia, Ventral Hernia
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DEVICEFortiva Tissue Matrix
Acellular Dermal Matrix used in hernia surgery
Sponsors
RTI Surgical
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 18 years of age at time of consent * Undergoing hernia surgery in which Fortiva Tissue Matrix will be used * Have no contraindications to the test material (s) * Able to provide informed consent * Able to read, understand and complete study questionnaires * Able and willing to return for scheduled study visits
Exclusion criteria
* \<18 years of age * American Society of Anesthesiologists (ASA) physical class of 4,5 or 6 * Currently enrolled or plans to enroll in another clinical study that would affect the validity of the study * Hernia repairs involving active infection
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Type of adverse events | 6 weeks, 6 months, 12 months and 24 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient satisfaction | 6 weeks, 6 months, 12 months and 24 months | 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 |
| Pain measured using the visual analog scale for pain | 6 weeks, 6 months, 12 months and 24 months | Visual Analog Scale using a scale of 0-10 with 0 being no pain and 10 being unbearable pain |
| Implant failure | 6 weeks, 6 months, 12 months and 24 months | Partial or total removal of Fortiva Tissue Matrix |
| Hernia recurrence | 12 months | Hernia recurrence requiring surgical reintervention |
Countries
United Kingdom
Outcome results
None listed