NCT04580524

Phasix Mesh Use in Complex Open Ventral Hernias Study

Poly-4-hydroxybutyrate Mesh Versus Current Care of Complex Open Ventral Hernias: A Multi-Center Randomized Controlled Trial

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: The University of Texas Health Science Center, Houston · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to compare clinical and patient centered outcomes of biosynthetic poly-4-hydroybutyrate meshes versus current care (synthetic polypropylene mesh or suture) for complex ventral hernia repair. The primary outcome for this study will be patients who are major complication free at 2 years postoperative. This will be a composite of hernia recurrence, reoperation, chronic wound complication, or death. Secondary outcomes include: surgical site occurences such as surgical site infection, seroma, hematoma and skin dehiscence within 90 days postoperative, emergency room visits withing 90 days postoperative, days in hospital up to 90 days postoperative, abdominal pain, and change in patient centered outcomes measured through the modified activities assessment scale (mAAS).

Conditions

• Ventral Hernia

Interventions

Type	Name	Description
PROCEDURE	Repair of ventral hernia using biologic mesh	Ventral hernia will be repaired using biologic mesh
PROCEDURE	Repair of ventral hernia using suture repair or synthetic mesh	Ventral hernia will be repaired using the current treatment methods

Timeline

• Start date: 2021-04-01
• Primary completion: 2021-04-01
• Completion: 2021-04-01
• First posted: 2020-10-08
• Last updated: 2023-06-22

Locations

2 sites across 1 country: United States