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

This study has been completed.
Sponsor:
Information provided by:
Aesculap AG
ClinicalTrials.gov Identifier:
NCT00646334
First received: March 18, 2008
Last updated: June 7, 2011
Last verified: June 2011
  Purpose

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 Intervention
Incisional Hernia Repair
Device: Mesh Implantation

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


Further study details as provided by Aesculap AG:

Primary Outcome Measures:
  • Physical function score of the SF-36 questionnaire [ Time Frame: 21 days after insertion ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • physical function score from the SF-36 questionnaire [ Time Frame: 6 months postoperatively ] [ Designated as safety issue: No ]
  • patient's daily activity [ Time Frame: 6 months postoperatively ] [ Designated as safety issue: No ]
  • patient's pain [ Time Frame: 6 months postoperatively ] [ Designated as safety issue: No ]
  • wound assessment [ Time Frame: 6 months postoperatively ] [ Designated as safety issue: No ]

Enrollment: 80
Study Start Date: June 2006
Study Completion Date: September 2010
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00646334

Locations
Germany
Krankenhaus Salem
Heidelberg, Baden-Wuerttemberg, Germany, 69121
Universitaetsklinikum Heidelberg
Heidelberg, Baden-Wuerttemberg, Germany, 69120
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
Investigators
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
  More Information

Publications:
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

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dr. Hanns-Peter Knaebel, Aesculap AG & Co. KG
ClinicalTrials.gov Identifier: NCT00646334     History of Changes
Other Study ID Numbers: AAG-G-H-0505
Study First Received: March 18, 2008
Last Updated: June 7, 2011
Health Authority: Germany: Ethics Commission

Keywords provided by Aesculap AG:
Large Pore Size Propylene Mesh
Incisional Hernia
Randomized Controlled Double-blind Study

Additional relevant MeSH terms:
Hernia
Hernia, Ventral
Hernia, Abdominal
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on October 23, 2014