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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00646334
Recruitment Status : Completed
First Posted : March 28, 2008
Last Update Posted : May 28, 2015
Information provided by (Responsible Party):
Aesculap AG

Tracking Information
First Submitted Date  ICMJE March 18, 2008
First Posted Date  ICMJE March 28, 2008
Last Update Posted Date May 28, 2015
Study Start Date  ICMJE June 2006
Actual Primary Completion Date September 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 25, 2008)
Physical function score of the SF-36 questionnaire [ Time Frame: 21 days after insertion ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 25, 2008)
  • physical function score from the SF-36 questionnaire [ Time Frame: 6 months postoperatively ]
  • patient's daily activity [ Time Frame: 6 months postoperatively ]
  • patient's pain [ Time Frame: 6 months postoperatively ]
  • wound assessment [ Time Frame: 6 months postoperatively ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title  ICMJE Comparative Study of AESCULAP Optilene® Mesh Elastic Versus Ethicon Ultrapro® Mesh in Incisional Hernia Repair
Official Title  ICMJE A Randomised, Multi-center, Prospective, Observer and Patient Blind Study to Evaluate AESCULAP Optilene® Mesh Elastic Versus Ethicon Ultrapro® Mesh in Incisional Hernia Repair
Brief 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Incisional Hernia Repair
Intervention  ICMJE
  • 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.
    Other Name: Optilene® Mesh Elastic
  • 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.
    Other Name: Ultrapro® Mesh
Study Arms  ICMJE
  • Experimental: A
    Optilene® Mesh Elastic
    Intervention: Device: Mesh Implantation
  • Active Comparator: B
    Ultrapro® Mesh
    Intervention: Device: Mesh Implantation
Publications *

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 25, 2008)
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE September 2010
Actual Primary Completion Date September 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Female or male patients >=18 years
  • Female patients are incapable of pragnancy or must be using adequate contraception and are not in lactation
  • Patients wiht vertical aponeurotic incisions only
  • Incisional hernia with hernia size >= 3 cm
  • Patient is capable to understand and to follow the instructions
  • written informed consent
  • no mesh implantation at the same site during a previous operation
  • immune competence of patient

Exclusion Criteria:

  • Simultanous participation in an investigational drug or medical device study
  • Patients < 18 years old
  • Incisional Hernia withe a hernia size < 3 cm
  • Repair of an acute incarcerated hernia
  • Previous mesh repair at the same site
  • Patient with other than vertical aponeurotic incisions
  • Enterotomy to be performed during hernia repair at Surgery
  • Patient is on anti-coagulations-therapy
  • Patient is known or assessed to be non-compliant
  • Additional surgical treatment at the same time (e.g. cholecystectomy)
  • Immune incompetence of patient (e.g. chemotherapy)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT00646334
Other Study ID Numbers  ICMJE AAG-G-H-0505
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Aesculap AG
Study Sponsor  ICMJE Aesculap AG
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Andreas Kuthe, Dr. DRK Krankenhaus Clementinenhaus, Hannover
Principal Investigator: Rainer Engemann, Prof. Dr. Klinikum Aschaffenburg, Chirurgische Klinik
Principal Investigator: Jens Kuhlgatz, Dr. Albert-Schweitzer-Krankenhaus, Klinik fuer Allgemein- und Viszeralchirurgie, Zentrum fuer Minimalinvasive Chirurgie, Northeim
Principal Investigator: Peter Kienle, Prof. Dr. Universitaetsklinikum Mannheim, Chirurgische Klinik
Principal Investigator: Markus Buechler, Prof.Dr.Dr. Universitaetsklinikum Heidelberg, Abt. fuer Allgemein-, Viszeral-, Unfallchirurgie und Poliklinik
Principal Investigator: Moritz von Frankenberg, Dr. Krankenhaus Salem, Chirurgische Abteilung, Heidelberg
PRS Account Aesculap AG
Verification Date May 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP