A prospective, single arm, multi-center study evaluating the short-term clinical outcomes of ventral hernias treated with OviTex® reinforced bioscaffold (Protocol TB2016.01.01)

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Trial ID:: IRB-16-6882; Mark Takata

The study is designed to demonstrate that the use of OviTex® 1S material for a ventral hernia repair leads to the same or a lower percentage of early post-operative complications and true hernia recurrences when compared to other types of available meshes. 100 subjects will be included from 5-7 participating investigator sites. Within 30 days prior to the hernia repair surgery, a baseline visit will be performed during which the patient's eligibility for the study will be evaluated. The surgical technique used for the repair will be determined by the investigator/surgeon. Additional study data will be collected during the hospital stay, 30 and 90 days post-operatively and 12 and 24 months post-operatively. At the follow up visits, the surgical site will be evaluated by the surgeon, both the surgeon and patient will be asked to rate their satisfaction with the repair and the subject will be asked to complete two Quality of Life questionnaires.

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) or Class II (Clean-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.

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