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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
80
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.
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.
Universitaetsklinikum Heidelberg
Heidelberg, Baden-Wurttemberg, Germany
Krankenhaus Salem
Heidelberg, Baden-Wurttemberg, Germany
Universitaetsklinikum Mannheim
Mannheim, Baden-Wurttemberg, Germany
Klinikum Aschaffenburg
Aschaffenburg, Bavaria, Germany
Physical function score of the SF-36 questionnaire
Time frame: 21 days after insertion
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
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Andreas Kuthe
Hanover, Lower Saxony, Germany
Albert-Schweitzer Krankenhaus
Northeim, Lower Saxony, Germany