Comparative Study of AESCULAP Optilene® Mesh Elastic Versus Ethicon Ultrapro® Mesh in Incisional Hernia Repair
Status
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Details and patient eligibility
About
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.
Enrollment
Sex
Ages
Volunteers
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)
Trial design
Primary purpose
Allocation
Interventional model
Masking
80 participants in 2 patient groups
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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