Status:
COMPLETED
Comparative Study of AESCULAP Optilene® Mesh Elastic Versus Ethicon Ultrapro® Mesh in Incisional Hernia Repair
Lead Sponsor:
Aesculap AG
Conditions:
Incisional Hernia Repair
Eligibility:
All Genders
18+ years
Phase:
NA
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®...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
June 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2010
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT00646334
Start Date
June 1 2006
End Date
September 1 2010
Last Update
May 28 2015
Active Locations (6)
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1
Universitaetsklinikum Heidelberg
Heidelberg, Baden-Wurttemberg, Germany, 69120
2
Krankenhaus Salem
Heidelberg, Baden-Wurttemberg, Germany, 69121
3
Universitaetsklinikum Mannheim
Mannheim, Baden-Wurttemberg, Germany, 68167
4
Klinikum Aschaffenburg
Aschaffenburg, Bavaria, Germany, 63739