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Completed

NCT Number: NCT00646334

Comparative Study of 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.

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Key information

Conditions

Incisional Hernia Repair Hernia Incisional Hernia Pathologic Processes Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Postoperative Complications

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Krankenhaus Salem, Heidelberg, Baden-Wurttemberg, Germany

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Mesh Implantation

Device

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 names: Optilene® Mesh Elastic

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

Sponsors and collaborators

Lead sponsor

Aesculap AG

Industry

Registry information

Official study 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

Acronym: Optilene

Important dates

Study start
2006
Primary completion
2010
Study completion
2010
First posted
Mar 28, 2008
Registry last updated
May 28, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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