Comparative Study of AESCULAP Optilene® Mesh Elastic Versus Ethicon Ultrapro® Mesh in Incisional Hernia Repair

Study Overview
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Brief Summary
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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.

Official Title
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A Randomised, Multi-center, Prospective, Observer and Patient Blind Study to Evaluate AESCULAP Optilene® Mesh Elastic Versus Ethicon Ultrapro® Mesh in Incisional Hernia Repair

Conditions
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Incisional Hernia Repair

Intervention / Treatment
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* Device: Mesh Implantation
* Device: Mesh Implantation


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br>Optilene® Mesh Elastic | Device: Mesh Implantation<br>* 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.<br>* Other names: Optilene® Mesh Elastic;|
| Active Comparator: B<br>Ultrapro® Mesh | Device: Mesh Implantation<br>* 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.<br>* Other names: Ultrapro® Mesh;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Physical function score of the SF-36 questionnaire |  | 21 days after insertion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| physical function score from the SF-36 questionnaire |  | 6 months postoperatively | 
| patient's daily activity |  | 6 months postoperatively | 
| patient's pain |  | 6 months postoperatively | 
| wound assessment |  | 6 months postoperatively | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Large Pore Size Propylene Mesh, Incisional Hernia, Randomized Controlled Double-blind Study