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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

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.

Condition or disease Intervention/treatment Phase
Incisional Hernia Repair Device: Mesh Implantation Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomised, Multi-center, Prospective, Observer and Patient Blind Study to Evaluate AESCULAP Optilene® Mesh Elastic Versus Ethicon Ultrapro® Mesh in Incisional Hernia Repair
Study Start Date : June 2006
Actual Primary Completion Date : September 2010
Actual Study Completion Date : September 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hernia

Arm Intervention/treatment
Experimental: A
Optilene® Mesh Elastic
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

Active Comparator: B
Ultrapro® Mesh
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

Primary Outcome Measures :
  1. Physical function score of the SF-36 questionnaire [ Time Frame: 21 days after insertion ]

Secondary Outcome Measures :
  1. physical function score from the SF-36 questionnaire [ Time Frame: 6 months postoperatively ]
  2. patient's daily activity [ Time Frame: 6 months postoperatively ]
  3. patient's pain [ Time Frame: 6 months postoperatively ]
  4. wound assessment [ Time Frame: 6 months postoperatively ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00646334

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Universitaetsklinikum Heidelberg
Heidelberg, Baden-Wuerttemberg, Germany, 69120
Krankenhaus Salem
Heidelberg, Baden-Wuerttemberg, Germany, 69121
Universitaetsklinikum Mannheim
Mannheim, Baden-Wuerttemberg, Germany, 68167
Klinikum Aschaffenburg
Aschaffenburg, Bayern, Germany, 63739
Andreas Kuthe
Hannover, Niedersachsen, Germany, 30161
Albert-Schweitzer Krankenhaus
Northeim, Niedersachsen, Germany, 37154
Sponsors and Collaborators
Aesculap AG
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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
Publications of Results:
Other Publications:
Schumpelick V, Arlt G, Klinge U. [Versorgung von Nabelhernien und Narbenhernien]. Dt. Aerzteblatt 94, Heft 51-52. Dez. 1997 (35)
Schumpelick V, Lloyd M. Meshes: benefits and risks, 9 Polypropylene: The standard of Mesh Materials. Nyhus Editors, Springer Verlag, 2004: 101-103
Benhidjeb T, Baerlehner E, Anders S. Laparoskopische Narbenhernien Reparation: Muss das Netz fuer die Intraperitoneale Onlay-Mesh-Technik besondere Eigenschaften haben?; Chir. Gastroenterol. 2003; 19(Suppl.2): 16-22
Rosen HR, Gyasi A; Retromuskulaere Kunststoffnetzimplantation von Narbenhernien; Chir. Gastroenterol.; 2003; 19 (Suppl. 2); 39-45
Rosch R, Junge K, Stumpf M, Klinge U, Schumpelick V, Klosterhalfen B; Welche Anforderungen sollte ein ideales Netz erfuellen?; Chir. Gastroenterol.; 2003; 19 (Suppl. 2); 7-11
Schumpelick V, van Ackeren H, Klinge U; Hernien; Thieme Verlag, 2000; 266-267

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Responsible Party: Aesculap AG Identifier: NCT00646334    
Other Study ID Numbers: AAG-G-H-0505
First Posted: March 28, 2008    Key Record Dates
Last Update Posted: May 28, 2015
Last Verified: May 2015
Keywords provided by Aesculap AG:
Large Pore Size Propylene Mesh
Incisional Hernia
Randomized Controlled Double-blind Study
Additional relevant MeSH terms:
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Incisional Hernia
Pathological Conditions, Anatomical
Postoperative Complications
Pathologic Processes