Ventral Hernia Study Using OviTex Reinforced Bioscaffold

Launched by TELA BIO INC · Mar 3, 2017

Keywords

ClinConnect Summary

The study is intended to evaluate the post-operative complications and re-herniations following the use of OviTex® Permanent 1S reinforced bioscaffold in subjects with ventral hernias. The study is designed to mirror surgical standard of care for ventral hernia intervention, with the exception of asking for subjects to return for evaluation at longer time points post-surgery than is typical for standard care. A baseline visit will be performed for patients who are identified for and provide informed consent to participate in the study. During this visit, a review of medical history, a physi...

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Subject suffers from an uncomplicated ventral hernia that requires surgical repair (open, laparoscopic, or robotic) with the use of an implant to reinforce or replace weakened or missing tissue.
• • The size of the implant needed for repair is expected to be 18 x 22 cm, 20 x 20 cm or less.
• • Subject meets CDC/SSI Wound Classification Class I (Clean), Class II (Clean-Contaminated) or Class III (Contaminated) criteria
• • Subject is willing and able to sign an informed consent for the study and has signed the IRB approved Informed Consent form for this study.
• • Subject is able to complete Quality of Life (QoL) and pain Questionnaires.
• • Subject is at least 18 years old (or considered an adult per state law).
• • Subject is able to participate fully in, and for the full duration of, the study.
• Exclusion Criteria:
• • Subject has a BMI of \> 40.
• • Subject meets CDC/SSI Wound Classification Class IV(Dirty-Infected) criteria.
• • Subject is female and is pregnant.
• • Subject has a life expectancy of \< 2 years making it unlikely that the subject will successfully achieve two-year follow-up.
• • Subject has recent history of drug or alcohol abuse (in last 3 years).
• • Subject has an allergy to ovine-derived products.
• • Subject has participated in another clinical trial within the past 30 days or is currently involved in another clinical trial.
• • Subject is unable to receive OviTex® Permanent 1S reinforced bioscaffold at the time of surgery.
• • Intra-operative Exclusion Criteria
• • Subject requires implant that exceeds 18 x 22 cm or 20 x 20 cm.
• • Subject unable to receive OviTex® Permanent 1S reinforced bioscaffold at time of surgery.