NCT01073072

Study Comparing Tutomesh® Repair to Conventional Surgical Techniques in Potentially Contaminated Hernia Repair and Abdominal Wall Reconstruction

Multicentric Prospective Randomized Study Comparing Technique of Tension-free Repair With Placement of a Bovine Pericardium Bioprosthesis (Tutopatch® and Tutomesh®) to Current Conventional Surgical Techniques in Potentially Contaminated Hernia Repair and Abdominal Wall Reconstruction

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 134 (actual)
• Sponsor: Centre Hospitalier Régional Universitaire Montpellier · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a multicentric prospective randomized study comparing technique of tension-free repair with placement of a bovine pericardium bioprosthesis (Tutopatch® and Tutomesh®) to current conventional surgical techniques in potentially contaminated hernia repair and abdominal wall reconstruction. The hypothesis is that using Tutomesh® prostheses reduces the risk of postoperative complications at 30 days in the treatment of incisional hernias or complicated abdominal wall hernias (ref early complications) for potentially contaminated fields.

Conditions

• Potentially Contaminated Hernia Repair
• Potentially Contaminated Abdominal Wall Reconstruction

Interventions

Type	Name	Description
PROCEDURE	Conventional technique	Conventional technique to repair potentially contaminated incisional or abdominal wall hernias
PROCEDURE	Technique Tutomesh®	Technique of abdominal wall reconstruction or hernia repair strengthened by Tutomesh® in potentially contaminated environment.

Timeline

• Start date: 2009-01-01
• Primary completion: 2010-10-01
• Completion: 2011-10-01
• First posted: 2010-02-23
• Last updated: 2012-03-16

Locations

19 sites across 1 country: France