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Prophylactic Mesh Implantation After Abdominal Aortic Aneurysm Repair

NCT01353443 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 282

Last updated 2023-05-23

No results posted yet for this study

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.

Conditions

  • Abdominal Aortic Aneurysm

Interventions

PROCEDURE

Optilene® Mesh Elastic

A number of patients will receive a Optilene® Mesh Elastic mesh, which may not be clinically indicated.

Sponsors & Collaborators

  • Aesculap AG

    collaborator INDUSTRY

  • Universitätsklinikum Hamburg-Eppendorf

    lead OTHER

Principal Investigators

  • Sebastian Debus, Prof. Dr. · University Heart Center Hamburg - Eppendorf

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-02-28
Primary Completion
2015-08-31
Completion
2015-09-30

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01353443 on ClinicalTrials.gov