Clinical Trial: Comparative Study of AESCULAP Optilene® Mesh Elastic Versus Ethicon Ultrapro® Mesh in Incisional Hernia Repair
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
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
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.
Detailed Summary:
Sponsor: Aesculap AG
Current Primary Outcome: Physical function score of the SF-36 questionnaire [ Time Frame: 21 days after insertion ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- physical function score from the SF-36 questionnaire [ Time Frame: 6 months postoperatively ]
- patient's daily activity [ Time Frame: 6 months postoperatively ]
- patient's pain [ Time Frame: 6 months postoperatively ]
- wound assessment [ Time Frame: 6 months postoperatively ]
Original Secondary Outcome: Same as current
Information By: Aesculap AG
Dates:
Date Received: March 18, 2008
Date Started: June 2006
Date Completion:
Last Updated: May 27, 2015
Last Verified: May 2015
