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

March 18, 2008
June 7, 2011
June 2006
September 2010   (final data collection date for primary outcome measure)
Physical function score of the SF-36 questionnaire [ Time Frame: 21 days after insertion ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00646334 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Comparative Study of AESCULAP Optilene® Mesh Elastic Versus Ethicon Ultrapro® Mesh in Incisional Hernia Repair
A Randomised, Multi-center, Prospective, Observer and Patient Blind Study to Evaluate AESCULAP Optilene® Mesh Elastic Versus Ethicon Ultrapro® Mesh in Incisional Hernia Repair

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Incisional Hernia Repair
  • 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
  • Experimental: A
    Optilene® Mesh Elastic
    Intervention: Device: Mesh Implantation
  • Active Comparator: B
    Ultrapro® Mesh
    Intervention: Device: Mesh Implantation

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
80
September 2010
September 2010   (final data collection date for primary outcome measure)

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)
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT00646334
AAG-G-H-0505
No
Dr. Hanns-Peter Knaebel, Aesculap AG & Co. KG
Aesculap AG
Not Provided
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
Aesculap AG
June 2011

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