Prophylactic Mesh Implantation After Abdominal Aortic Aneurysm Repair

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Aesculap AG
Information provided by (Responsible Party):
Universitätsklinikum Hamburg-Eppendorf
ClinicalTrials.gov Identifier:
NCT01353443
First received: April 18, 2011
Last updated: August 13, 2013
Last verified: August 2013
  Purpose

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 Intervention Phase
Abdominal Aortic Aneurysm
Procedure: Optilene® Mesh Elastic
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Prophylactic Mesh Implantation After Abdominal Aortic Aneurysm Repair. A Prospective, Randomised, Controlled Study

Resource links provided by NLM:


Further study details as provided by Universitätsklinikum Hamburg-Eppendorf:

Primary Outcome Measures:
  • Herniation rate [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    As an indicator of efficacy, the reduction of herniation rate will be verified by clinical examination and confirmed by Ultrasound.


Estimated Enrollment: 282
Study Start Date: February 2011
Estimated Study Completion Date: September 2015
Estimated Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01353443

Locations
Germany
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
Asklepios Klinik Altona
Hamburg, Germany, 22763
Asklepios Klinik Wandsbek
Hamburg, Germany, 22043
University Heart Center Hamburg-Eppendorf
Hamburg, Germany, 20246
Klinikum Ludwigsburg
Ludwigsburg, Germany, 71640
Sponsors and Collaborators
Universitätsklinikum Hamburg-Eppendorf
Aesculap AG
Investigators
Principal Investigator: Sebastian Debus, Prof. Dr. University Heart Center Hamburg - Eppendorf
  More Information

No publications provided

Responsible Party: Universitätsklinikum Hamburg-Eppendorf
ClinicalTrials.gov Identifier: NCT01353443     History of Changes
Other Study ID Numbers: AIDA Study
Study First Received: April 18, 2011
Last Updated: August 13, 2013
Health Authority: Germany: Ethics Commission

Keywords provided by Universitätsklinikum Hamburg-Eppendorf:
Abdominal Aortic Aneurysm
AAA

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

ClinicalTrials.gov processed this record on October 21, 2014