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Comparative Study of AESCULAP Optilene® Mesh Elastic Versus Ethicon Ultrapro® Mesh in Incisional Hernia Repair

NCT00646334 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2015-05-28

No results posted yet for this study

Summary

Optilene® Mesh Elastic and Ultrapro® Mesh will be used for incisional hernia repair. The primary objective of this clinical study is to demonstrate that Optilene® Mesh Elastic is superior to Ultrapro® Mesh in incisional hernia repair in matter of the physical function score from the SF-36 questionnaire 21 days after mesh insertion. Secondary objectives include the patient's daily activity, the rating of patients pain and the wound assessment determined on several occasions during the six months observation time.

Conditions

  • Incisional Hernia Repair

Interventions

DEVICE

Mesh Implantation

An elective incisional Hernia repair is performed by using Optilene® Mesh Elastic, a lightweight and large pore mesh, knitted from monofilament polypropylene. Due to the multidirectional elasticity the mesh is able to adapt to all movements taking place in the abdominal wall.

DEVICE

Mesh Implantation

Ultrapro® Mesh is a knitted, partly absorbable, lightweight mesh, consisting of equal parts of nonabsorbable polypropylene and absorbable polyglecaprone (Monocryl®). Polyglecaprone is fully absorbed in the body by hydrolysis. The addition of polyglecapron filament is only intended to reinforce the mesh to allow a convenient intraoperative handling and mesh placement, without additional function. Ultrapro® is an elastic mesh having enlarged elasticity cross to the blue strips.

Sponsors & Collaborators

  • Aesculap AG

    lead INDUSTRY

Principal Investigators

  • Andreas Kuthe, Dr. · DRK Krankenhaus Clementinenhaus, Hannover

  • Rainer Engemann, Prof. Dr. · Klinikum Aschaffenburg, Chirurgische Klinik

  • Jens Kuhlgatz, Dr. · Albert-Schweitzer-Krankenhaus, Klinik fuer Allgemein- und Viszeralchirurgie, Zentrum fuer Minimalinvasive Chirurgie, Northeim

  • Peter Kienle, Prof. Dr. · Universitaetsklinikum Mannheim, Chirurgische Klinik

  • Markus Buechler, Prof.Dr.Dr. · Universitaetsklinikum Heidelberg, Abt. fuer Allgemein-, Viszeral-, Unfallchirurgie und Poliklinik

  • Moritz von Frankenberg, Dr. · Krankenhaus Salem, Chirurgische Abteilung, Heidelberg

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-06-30
Primary Completion
2010-09-30
Completion
2010-09-30

Countries

  • Germany

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 NCT00646334 on ClinicalTrials.gov