Tulane University, VA grant IRB approval for new TIGR Matrix clinical trial in hernia repair

NOVUS SCIENTIFICJun 16 2011

Novus Scientific today announced that Tulane University School of Medicine and Department of Veterans Affairs have granted IRB approval to a new trial: A Study Evaluating Efficacy of TIGR® Matrix Surgical Mesh used in Elective Open Inguinal Hernia Repair.

This study aims to measure recurrence rates and Quality of Life (QOL) factors by evaluating post-operative pain and foreign body sensation. Recent clinical data suggests chronic post-herniorrhaphy pain is experienced by 14 - 54% of patients. In up to 21% of these patients, the pain is such that they are functionally impaired in work and leisure activities. There is some indication that the type of mesh used during the repair may influence the incidence, severity and type of chronic pain following herniorrhaphy with lightweight meshes demonstrating a decrease in both short and long-term pain in several studies, i.e. less pain and foreign body sensation versus heavyweight meshes. - A Pilot Study, Evaluating Efficacy of TIGR Matrix Surgical Mesh, Used in Elective Open Inguinal Hernia Repair, Charles F. Bellows, 2011.

TIGR® Matrix is the World's 1st Long-Term Resorbable Synthetic Mesh, which has the potential to reduce post herniorrhaphy pain, foreign body sensation and other permanent mesh related complications by being strong for 6 months and fully disappearing in 3 years.

"TIGR® Matrix is the next generation in the category of resorbable synthetic prostheses," stated Charles Bellows, MD, FACS, Chief, General Surgery and Minimally Invasive Surgery and principal investigator of the study. "Given its structure and design, TIGR® Matrix should facilitate the generation of neovascularized, healthy tissue, without the long-term complications associated with permanent mesh. The design of this study allows us to track not just recurrence rate, but also quality of life of the patients, which we anticipate will improve in the long term." - Charles Bellows MD FACS, Study Principle Investigator, Associate Professor of Surgery Chief, Tulane University Health Sciences Center.