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

Not Applicable

Completed

• Conditions: Incisional Hernia Repair
• Interventions: Device: Mesh Implantation

• Registration Number: NCT00646334
• Lead Sponsor: Aesculap AG

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 Description

Not available

Study Timeline

• Study Start: 2006-06
• Study First Submitted: 2008-03-18
• Study First Submitted QC: 2008-03-25
• Study First Posted: 2008-03-28
• Primary Completion: 2010-09
• Study Completion: 2010-09
• Status Verified: 2015-05
• Last Update Submitted: 2015-05-27
• Last Update Posted: 2015-05-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A	Mesh Implantation	Optilene® Mesh Elastic
B	Mesh Implantation	Ultrapro® Mesh

Primary Outcome Measures

Name	Time	Method
Physical function score of the SF-36 questionnaire	21 days after insertion

Secondary Outcome Measures

Name	Time	Method
patient's daily activity	6 months postoperatively
wound assessment	6 months postoperatively
physical function score from the SF-36 questionnaire	6 months postoperatively
patient's pain	6 months postoperatively

Trial Locations

Locations (6)

Universitaetsklinikum Heidelberg; 🇩🇪 Heidelberg, Baden-Wuerttemberg, Germany

Klinikum Aschaffenburg; 🇩🇪 Aschaffenburg, Bayern, Germany

Andreas Kuthe; 🇩🇪 Hannover, Niedersachsen, Germany

Albert-Schweitzer Krankenhaus; 🇩🇪 Northeim, Niedersachsen, Germany

Krankenhaus Salem; 🇩🇪 Heidelberg, Baden-Wuerttemberg, Germany

Universitaetsklinikum Mannheim; 🇩🇪 Mannheim, Baden-Wuerttemberg, Germany