- Trial ID:
- Mark Takata
- 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.
- 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.
Why isn't this trial accepting new patients?
The trial may have a limited enrollment number, reached its maximum, or come to the end of its enrollment period. View trials that are recruiting
How else can Scripps help me?
We have a broad range of physician expertise and specialized medical services available. You can find a doctor online, call 1-800-SCRIPPS (1-800-727-4777) for personal help, or see related Scripps services.
How can I find trials that are accepting new participants?
For more information, see a list of trials that are recruiting, or call the clinical research office at 858-648-6402 for help.