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

Study Overview
=================
Brief 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.

Official Title
-----------------
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

Conditions
-----------------
Potentially Contaminated Hernia Repair, Potentially Contaminated Abdominal Wall Reconstruction

Intervention / Treatment
-----------------
* Procedure: Conventional technique
* Procedure: Technique Tutomesh®


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tutomesh<br>Technique of abdominal wall reconstruction strengthened by Tutomesh® | Procedure: Technique Tutomesh®<br>* Technique of abdominal wall reconstruction or hernia repair strengthened by Tutomesh® in potentially contaminated environment.<br>|
| Active Comparator: conventional repair<br>Conventional technique to repair incisional or abdominal wall hernias | Procedure: Conventional technique<br>* Conventional technique to repair potentially contaminated incisional or abdominal wall hernias<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| risk of postoperative complications: occurrence of complications related to pathology or surgery will be evaluated with the report of adverse events and emergency visits |  | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| recurrence risk: Assessment of relapse thanks to emergency visits and to adverse events' report |  | 1 year | 
| the impact on postoperative pain: Assessment of postoperative pain by postponing analgesics |  | 1 year | 
| the socio-economic impact will be evaluated with the concomitant treatment and hospitalisations. |  | 1 year | 
| the impact on patients' quality of life: The evaluation of patient's quality of life will be done with the questionnaire quality of life SF12 |  | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
bovine pericardium bioprosthesis, contamination, hernia repair, abdominal wall reconstruction, Tutomesh, Tutopatch, Potentially Contaminated Hernia Repair, Potentially Contaminated Abdominal Wall Reconstruction