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

NCT01073072 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 134

Last updated 2012-03-16

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Centre Hospitalier Régional Universitaire Montpellier

    lead OTHER

Principal Investigators

  • David Nocca, Dr · University Hospital, Montpellier

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-01-31
Primary Completion
2010-10-31
Completion
2011-10-31

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01073072 on ClinicalTrials.gov