Resorbable Mesh Evaluated to Prevent Incisional Hernias After Abdominal Surgery

Preventive strategies remain limited, and there are currently no products approved specifically for this indication. A new large-scale randomized trial now evaluates prophylactic use of a resorbable mesh to address this gap.

BD (Becton, Dickinson and Company) has completed enrollment in the PREVENT clinical trial, which is evaluating Phasix Mesh for prevention of incisional hernias. The study enrolled 477 patients across 32 sites in the United States and Europe. It is described as the first large, randomized study assessing prophylactic reinforcement for incisional hernia prevention using a resorbable mesh.

Phasix Mesh is being studied as a resorbable mesh for prophylactic reinforcement to reduce the incidence of incisional hernia. PREVENT focuses on patients undergoing elective open midline abdominal surgery who are at high risk for hernia development. The trial aims to generate robust clinical evidence for this prevention strategy.

Patients in PREVENT will be followed through a primary endpoint assessed at 24 months. Longer-term follow-up is planned through five years to further evaluate safety and clinical outcomes. Following completion of the primary endpoint assessments, data from the study are expected to support a planned submission to the U.S. Food and Drug Administration as part of the regulatory pathway for this indication.

“PREVENT reflects our commitment to extending the impact of advanced tissue regeneration into new areas of patient care. By evaluating Phasix™ Mesh in hernia prevention, we are building on decades of innovation in abdominal wall surgery and generating evidence that could help broaden the role of regenerative technologies for patients at risk of post-surgical complications. We are grateful to the investigators, clinical sites and patients whose participation made this achievement possible,” said Rian Seger, worldwide president of Surgery at BD.