Fortiva Tissue Matrix: Acellular Dermal Matrix used in hernia surgery
Study 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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
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
Primary outcome measure(s)
Type of adverse events — 6 weeks, 6 months, 12 months and 24 months
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
We use cookies to analyse site traffic and improve your experience. With your consent, we may also use cookies for advertising. You can change your choice at any time on our Cookie Policy page. See also our Privacy Policy.