Phasix™ Mesh for Open Laparotomy Recovery

(PREVENT Trial)

This trial tests a new method for closing the abdomen after major surgery in the belly area. Researchers aim to determine if using a special mesh called Phasix™ Mesh can prevent hernias (a bulge or lump that can occur after surgery) more effectively than stitching the area closed. Participants who have undergone open midline laparotomy (a large surgical cut along the middle of the belly) and are at moderate or higher risk for a hernia might be suitable candidates. As an unphased trial, this study allows participants to contribute to innovative surgical techniques that could enhance recovery outcomes for future patients.

The trial does not specify if you need to stop taking your current medications, but if you are on medication that might affect wound healing, you may not be eligible to participate.

Research has shown that Phasix™ Mesh is generally safe and well-tolerated. In one study, patients using this mesh did not experience any long-term problems. The chance of hernia recurrence was low, with only 15.9% of cases experiencing a recurrence over five years. Another study found no infections related to the mesh and only a few other issues. These results suggest that the mesh is safe for individuals needing hernia repair.¹²³⁴⁵

Researchers are excited about Phasix™ Mesh for open laparotomy recovery because it offers a novel approach to preventing complications like hernias after surgery. Unlike traditional methods, which rely solely on primary suture closure, Phasix™ Mesh involves a prophylactic onlay placement of a bioresorbable mesh. This mesh is designed to reinforce the surgical site, providing added support and potentially reducing the risk of hernia formation over time. Its bioresorbable nature means it gradually dissolves in the body, minimizing long-term foreign material presence and potentially improving patient outcomes.

Research has shown that Phasix™ Mesh might help prevent hernias after surgery. One study found that only 15.9% of patients experienced hernia recurrence over five years, with no long-term issues from the mesh. Another study reported a 10.3% hernia recurrence rate after one year in patients with complex hernia repairs using the mesh. In this trial, participants will either receive the Phasix™ Mesh or undergo primary suture closure. These findings suggest that Phasix™ Mesh could reduce the risk of hernia recurrence, with few complications.²³⁶⁷⁸