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

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.

Inclusion Criteria:

• Patient presenting with an incisional hernia or complicated hernia contraindicating the use of non absorbable mesh:

  • Infected incisional hernia: abdominal wall abscess, chronic fistula
  • Incisional hernia with high septic potential: incisional hernia with strangulation of one or more intestinal loops, repair of incisional hernia during surgery requiring opening of the digestive tube (digestive resection, restoration of digestive continuity, gastro-intestinal perforation, peritonitis from digestive origin)
  • Recurrent incisional hernia with problem of cutaneous healing
  • Incisional hernia requiring important intestinal adhesiolysis

• Patients signing informed consent form after reading and understanding the information letter _ Patients are more than 18 year old

Exclusion Criteria:

• Patient with major anesthetic risk (ASA 4)
• Patient suffering from immunodepression or under immunosuppressor treatment (corticoids…)
• Patients already enrolled in another study
• Patient suffering from severe disease not allowing a 1-year follow-up
• Patient refusing to be enrolled after consulting the information letter
• Patient presenting with a too large incisional hernia, superior to 140x200 mm
• Pregnancy