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Prophylactic Mesh Implantation After Abdominal Aortic Aneurysm Repair

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ClinicalTrials.gov Identifier: NCT01353443
Recruitment Status : Unknown
Verified November 2014 by Universitätsklinikum Hamburg-Eppendorf.
Recruitment status was:  Active, not recruiting
First Posted : May 13, 2011
Last Update Posted : November 19, 2014
Aesculap AG
Information provided by (Responsible Party):
Universitätsklinikum Hamburg-Eppendorf

Brief Summary:

AIDA Study is a prospective, multicentre, randomized, controlled clinical investigation with patients undergoing median laparotomy for Abdominal Aortic Aneurysm (AAA) repair.

The primary objective of the clinical investigation is to test the hypothesis that insertion of an Optilene® Mesh Elastic mesh - a monofilament, light-weight, large pore sized, polypropylene mesh manufactured by Aesculap AG - is superior to suturing alone and will reduce the hernia formation rate within the first 2 years.

A reduction from 30% to 10% of the patient population is assumed.

Condition or disease Intervention/treatment Phase
Abdominal Aortic Aneurysm Procedure: Optilene® Mesh Elastic Phase 4

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 282 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Prophylactic Mesh Implantation After Abdominal Aortic Aneurysm Repair. A Prospective, Randomised, Controlled Study
Study Start Date : February 2011
Estimated Primary Completion Date : August 2015
Estimated Study Completion Date : September 2015

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
No Intervention: Group A
Monofilament absorbable MonoPlus® suture material will be used for closing of the midline incision.
Group B
Abdominal wall closure with monofilament absorbable MonoPlus® suture material and onlay placement of Optilene® Mesh Elastic fixed by sutures.
Procedure: Optilene® Mesh Elastic
A number of patients will receive a Optilene® Mesh Elastic mesh, which may not be clinically indicated.
No Intervention: Group C
Monofilament, absorbable MonoMax suture material will be used for the closure of the abdominal cavity.

Primary Outcome Measures :
  1. Herniation rate [ Time Frame: 24 months ]
    As an indicator of efficacy, the reduction of herniation rate will be verified by clinical examination and confirmed by Ultrasound.

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Male and female patients >18 years of age.
  2. Patients undergoing an elective surgery for AAA repair.
  3. Patients who currently have no malignant disease requiring therapy.
  4. Patients who are able to fulfill all clinical investigation requirements
  5. Patients who have provided written informed consent.

Exclusion Criteria:

  1. Patients who require median laparotomy for AAA repair as an emergency procedure.
  2. Expected length of fascia incision > 30 cm.
  3. Patients with coagulopathy
  4. Patients who have had previous median laparotomy and/or laparotomy crossing the incision necessary for AAA laparotomy.
  5. Patients with current immunosuppressive therapy (>40 mg corticoid/day or azathioprine).
  6. Chemotherapy within the last 4 weeks.
  7. Radiotherapy on the treated region within the last 2 months.
  8. Pregnant and breast-feeding women.
  9. Known allergy against ingredients of the investigational products (polypropylene, poly-4-hydroxybutyrate, polydioxanone).
  10. Patients participating in other investigational drug or medical device studies within the preceding 4 weeks.
  11. Patients with an ongoing medical condition or social reason that may affect their ability to complete the two years follow-up period.
  12. Life expectancy less than 24 months.
  13. Severe psychiatric or neurologic disease.
  14. Lack of compliance.
  15. Drug abuse.
  16. Inability to understand and follow the instructions given by the investigator (e.g. dementia, lack of time, insufficient command of language).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01353443

Klinikum Stuttgart - Katharinenhospital (KH)
Stuttgart, Baden-Wurttemberg, Germany, 70174
Klinikum Nürnberg Süd
Nürnberg, Bavaria, Germany, 90471
Universitätsklinikum Würzburg
Würzburg, Bavaria, Germany, 97080
Klinikum Bremen-Nord
Bermen, Bremen, Germany, 28755
Universitätsklinikum Aachen
Aachen, North Rhine-Westphalia, Germany, 52074
University Heart Center Hamburg-Eppendorf
Hamburg, Germany, 20246
Asklepios Klinik Wandsbek
Hamburg, Germany, 22043
Asklepios Klinik Altona
Hamburg, Germany, 22763
Klinikum Ludwigsburg
Ludwigsburg, Germany, 71640
Sponsors and Collaborators
Universitätsklinikum Hamburg-Eppendorf
Aesculap AG
Principal Investigator: Sebastian Debus, Prof. Dr. University Heart Center Hamburg - Eppendorf

Responsible Party: Universitätsklinikum Hamburg-Eppendorf
ClinicalTrials.gov Identifier: NCT01353443     History of Changes
Other Study ID Numbers: AIDA Study
First Posted: May 13, 2011    Key Record Dates
Last Update Posted: November 19, 2014
Last Verified: November 2014

Keywords provided by Universitätsklinikum Hamburg-Eppendorf:
Abdominal Aortic Aneurysm

Additional relevant MeSH terms:
Aortic Aneurysm
Aortic Aneurysm, Abdominal
Vascular Diseases
Cardiovascular Diseases
Aortic Diseases