Transorb™ Self-Gripping Resorbable Mesh in High-risk Subjects Undergoing Open Repair of Ventral Hernia (NCT06449378)

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

1. Subject has provided informed consent
2. Subject is 18 years of age or older at the time of consent
3. Subject is undergoing a planned, elective, open, single-staged repair of a midline primary or incisional ventral hernia using retrorectus/retromuscular mesh placement with or without Transversus Abdominis Release (TAR)
4. Subject is expected to meet the criteria for:
5. In the US: a class I / clean wound as defined by the CDC (Centers for Disease Control and Prevention) wound classification
6. In Europe: a class I / clean wound or a class II / clean-contaminated wound as defined by the CDC wound classification in compliance with these conditions:
7. No break in the sterile technique, and
8. Entry into gastrointestinal tract with no or minimal spillage
9. Subject has at least one of the following comorbid factors impairing wound healing:
10. Current smokers (subject who has smoked 100 cigarettes in his or her lifetime and who currently smokes) Note: Use smoking status prior to preoperative optimization for inclusion assessment.
11. Smokers with a minimum 20 pack year history (including former smokers)
12. Obesity, defined as body Mass Index (BMI) between 30kg/m2 and 39.9kg/m2

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (13 Sites)

• Northwestern University — Evanston, Illinois
• University of Kentucky — Lexington, Kentucky
• Novant Health New Hanover Regional Medical Center — Wilmington, North Carolina
• Cleveland Clinic Foundation — Cleveland, Ohio
• The Ohio State University — Columbus, Ohio
• TPMG General Surgery and Hernia Center — Newport News, Virginia
• UZ Leuven, campus Gasthuisberg — Leuven,
• APHP Hospital Louis Mourier — Colombes,
• Centre Hospitalier Universitaire de Lille — Lille,
• Hospices Civils de Lyon — Lyon,
• Centre Hospitalier Universitaire de Reims — Reims,
• Hôpital Charles Nicolle Centre Hospitalier Universitaire de Rouen — Rouen,
• Hôpitaux Universitaires de Strasbourg — Strasbourg,

💰 Cost, Insurance & Patient Rights

• 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
• Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
• Voluntary Participation: You may withdraw at any time without affecting your standard medical care.