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CompletedNCT00646334OptileneUpdated May 28, 2015

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

An interventional study of Mesh Implantation and Mesh Implantation in Incisional Hernia Repair, sponsored by Aesculap AG. Completed at 6 sites in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-05-28.

Sponsored by Aesculap AG · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
80
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

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.

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Conditions studied

  • Incisional Hernia Repair

Keywords

  • Large Pore Size Propylene Mesh
  • Incisional Hernia
  • Randomized Controlled Double-blind Study
03

In context

Hernia

1,096 studies on the registry are indexed under Hernia; 132 are open to participants now.

This study's enrollment of 80 is close to the median of 80 across 739 interventional studies indexed under Hernia.

Browse Hernia studies →

Lead sponsor

Aesculap AG is the lead sponsor of 104 studies on the registry; 20 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
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

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)
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
80 participants (actual)

Study arms

  • Experimental
    A

    Optilene® Mesh Elastic

    Device: Mesh Implantation

  • Active comparator
    B

    Ultrapro® Mesh

    Device: Mesh Implantation

Interventions

  • DeviceMesh 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.

    Also known as: Optilene® Mesh Elastic

  • DeviceMesh 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.

    Also known as: Ultrapro® Mesh

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What researchers measure

Primary outcomes

  1. Physical function score of the SF-36 questionnaire

    Time frame: 21 days after insertion

Secondary outcomes

  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

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Study locations

6 sites
  • Universitaetsklinikum Heidelberg
    Heidelberg, Baden-Wuerttemberg 69120, Germany
  • Krankenhaus Salem
    Heidelberg, Baden-Wuerttemberg 69121, Germany
  • Universitaetsklinikum Mannheim
    Mannheim, Baden-Wuerttemberg 68167, Germany
  • Klinikum Aschaffenburg
    Aschaffenburg, Bayern 63739, Germany
  • Andreas Kuthe
    Hannover, Niedersachsen 30161, Germany
  • Albert-Schweitzer Krankenhaus
    Northeim, Niedersachsen 37154, Germany
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References and documents

Publications

  • Cassar K, Munro A. Surgical treatment of incisional hernia. Br J Surg. 2002 May;89(5):534-45. doi: 10.1046/j.1365-2168.2002.02083.x. PubMed 11972542 ↗
  • Schumpelick V, Arlt G, Klinge U. [Versorgung von Nabelhernien und Narbenhernien]. Dt. Aerzteblatt 94, Heft 51-52. Dez. 1997 (35)
  • Klinge U, Conze J, Limberg W, Brucker C, Ottinger AP, Schumpelick V. [Pathophysiology of the abdominal wall]. Chirurg. 1996 Mar;67(3):229-33. German. PubMed 8681695 ↗
  • Klinge U, Conze J, Klosterhalfen B, Limberg W, Obolenski B, Ottinger AP, Schumpelick V. [Changes in abdominal wall mechanics after mesh implantation. Experimental changes in mesh stability]. Langenbecks Arch Chir. 1996;381(6):323-32. doi: 10.1007/BF00191312. German. PubMed 9082105 ↗
  • Schumpelick V, Lloyd M. Meshes: benefits and risks, 9 Polypropylene: The standard of Mesh Materials. Nyhus Editors, Springer Verlag, 2004: 101-103
  • Beets GL, Go PM, van Mameren H. Foreign body reactions to monofilament and braided polypropylene mesh used as preperitoneal implants in pigs. Eur J Surg. 1996 Oct;162(10):823-5. PubMed 8934114 ↗
  • Klinge U, Klosterhalfen B, Birkenhauer V, Junge K, Conze J, Schumpelick V. Impact of polymer pore size on the interface scar formation in a rat model. J Surg Res. 2002 Apr;103(2):208-14. doi: 10.1006/jsre.2002.6358. PubMed 11922736 ↗
  • 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
  • Seiler C, Baumann P, Kienle P, Kuthe A, Kuhlgatz J, Engemann R, V Frankenberg M, Knaebel HP. A randomised, multi-centre, prospective, double blind pilot-study to evaluate safety and efficacy of the non-absorbable Optilene Mesh Elastic versus the partly absorbable Ultrapro Mesh for incisional hernia repair. BMC Surg. 2010 Jul 12;10:21. doi: 10.1186/1471-2482-10-21. PubMed 20624273 ↗
  • Rickert A, Kienle P, Kuthe A, Baumann P, Engemann R, Kuhlgatz J, von Frankenberg M, Knaebel HP, Buchler MW. A randomised, multi-centre, prospective, observer and patient blind study to evaluate a non-absorbable polypropylene mesh vs. a partly absorbable mesh in incisional hernia repair. Langenbecks Arch Surg. 2012 Dec;397(8):1225-34. doi: 10.1007/s00423-012-1009-6. Epub 2012 Oct 3. PubMed 23053458 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 28, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00646334
Lead sponsor
Aesculap AG
Responsible party
Sponsor
First posted
Mar 28, 2008
Start date
Jun 2006
Primary completion
Sep 2010
Completion
Sep 2010
Last update
May 28, 2015

Study contacts

Andreas Kuthe, Dr.
principal investigator · DRK Krankenhaus Clementinenhaus, Hannover
Rainer Engemann, Prof. Dr.
principal investigator · Klinikum Aschaffenburg, Chirurgische Klinik
Jens Kuhlgatz, Dr.
principal investigator · Albert-Schweitzer-Krankenhaus, Klinik fuer Allgemein- und Viszeralchirurgie, Zentrum fuer Minimalinvasive Chirurgie, Northeim
Peter Kienle, Prof. Dr.
principal investigator · Universitaetsklinikum Mannheim, Chirurgische Klinik
Markus Buechler, Prof.Dr.Dr.
principal investigator · Universitaetsklinikum Heidelberg, Abt. fuer Allgemein-, Viszeral-, Unfallchirurgie und Poliklinik
Moritz von Frankenberg, Dr.
principal investigator · Krankenhaus Salem, Chirurgische Abteilung, Heidelberg

Oversight

Data monitoring committee
No
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