Prevention of incisional hernia in high-risk patients with prophylactic slowly-resorbable TIGR® Matrix mesh in midline laparotomies.
Not yet recruiting
- Conditions
- Prevention of incisional hernia in high-risk patients
- Registration Number
- NL-OMON22803
- Lead Sponsor
- ovus Scientific AB, Uppsala Sweden
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 70
Inclusion Criteria
Elective midline laparotomy for patients with Abdominal Aortic Aneurysm.
-Age = 18 years.
-Signed informed consent by patient.
Exclusion Criteria
-Pregnancy.
-Emergency procedures.
-Inclusion in other trials with interference of the primary endpoint.
-Life expectancy less than 24 months (as estimated by the attending physician).
-Immune suppression therapy within 2 weeks before surgery.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary objective is to examine the effectiveness of incisional hernia prevention with synthetic, slowly-resorbable TIGR® Matrix mesh placement in patients with AAA undergoing midline laparotomy.
- Secondary Outcome Measures
Name Time Method The secondary objectives are to measure relevant postoperative complications, postoperative pain, sensitivity of the skin in the area of the mesh placement and quality of life.