MedTrace Logo

Prevention of Incisional Hernia After Elective Open Abdominal Aortic Aneurysm (AAA) Repair

NCT01189708 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 9

Last updated 2023-09-18

No results posted yet for this study

Summary

The aim of this study is to investigate the effect of the implantation of an Ultrapro® Mesh as prevention of incisional hernia after elective open abdominal aortic aneurysm repair. According to the literature these patients have an increased risk for an incisional hernia. By the implantation of an artificial mesh into the abdominal wall during the first abdominal aortic aneurysm repair, the risk can be reduced dramatically. In small feasibility studies incisional hernia rates as low as 0% have been achieved.

Patients scheduled for elective open abdominal aortic aneurysm repair will be randomized into two groups, one receiving an onlay mesh, the other conventional wound closure with sutures.

Conditions

  • Abdominal Aortic Aneurysm

Interventions

DEVICE

Ultrapro® Mesh implantation

After the aortic procedure (aortic aneurysm repair) an Ultrapro absorbable mesh will be used for the wound closure of the abdominal wall using an onlay technique.

OTHER

Standard wound closure

Abdominal closure will be performed with standard sutures without a mesh.

Sponsors & Collaborators

  • Cantonal Hospital of St. Gallen

    lead OTHER

Principal Investigators

  • Wolfgang Nagel, MD · KSSG

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-03-31
Primary Completion
2009-04-30
Completion
2011-04-30

Countries

  • Switzerland

Study Locations

More Related Trials

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 NCT01189708 on ClinicalTrials.gov