Silver Acetate and Triclosan Antimicrobial Graft Evaluation for Surgical Repair of Aortic Disease

November 25, 2021 updated by: Prof. Andrea Kahlberg, IRCCS San Raffaele

A Retrospective Single-center Comparative Analysis of Early and Long-term Results of Aortic Surgical Replacement Using Silver Acetate and Triclosan Impregnated Antimicrobial Grafts Versus Standard Dacron Vascular Grafts

The number of surgical and endovascular aortic repairs is continuously increasing, and infective graft complications are observed more frequently. (1) Several etiopathogenetic factors may play a role in aortic prosthetic infections, including hematogenous seeding, local bacterial translocation, and iatrogenous contamination. Infectious graft complications represent a critical event requiring a multidisciplinary management. Knowledge on underlying microorganisms, antibiotic efficacy, risk factors, and prevention strategies has a key role in the management of this spectrum of infectious diseases involving the aorta.

the aim of the study is evaluate the early and long-term clinical results, up to 5 years (through follow-up outpatient visits), of a silver and triclosan knitted collagen coated polyester vascular graft (InterGard Synergy), in patients submitted to aortic surgical repair, and compare them with concurrent results of standard Dacron grafts. Results will be reported and analyzed according to the type of aortic disease requiring surgical repair.

Study Overview

Status

Completed

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Milano, Italy, 20132
        • IRCCS San Raffaele Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients who have surgery aortic repair in which it was used a prosthesis containing antimicrobial agents or a standard vascular prosthesis (Dacron)

Description

Inclusion Criteria:

• Patients submitted to aortic surgical repair (elective or emergent) with a silver and triclosan knitted collagen coated polyester vascular graft or standard Dacron grafts, for different aortic pathologies at the Division of Vascular Surgery, San Raffaele Scientific Institute, between 2012 and 2019

Exclusion Criteria:

• not present

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
silver-triclosan graft implantation (SynG group)
evaluate the early and long-term clinical results, up to 5 years (through follow-up outpatient visits), of a silver and triclosan knitted collagen coated polyester vascular graft (InterGard Synergy), in patients submitted to aortic surgical repair, and compare them with concurrent results of standard Dacron grafts.
standard Dacron graft implantation (DacrG group)
evaluate the early and long-term clinical results, up to 5 years (through follow-up outpatient visits), of a silver and triclosan knitted collagen coated polyester vascular graft (InterGard Synergy), in patients submitted to aortic surgical repair, and compare them with concurrent results of standard Dacron grafts.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of patients without infectious complications
Time Frame: 30 days
freedom from infectious complications (percentage)
30 days
Number of patients without infectious complications
Time Frame: 5 years
freedom from infectious complications (percentage)
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 25, 2020

Primary Completion (Actual)

August 31, 2021

Study Completion (Actual)

September 15, 2021

Study Registration Dates

First Submitted

September 8, 2020

First Submitted That Met QC Criteria

September 15, 2020

First Posted (Actual)

September 21, 2020

Study Record Updates

Last Update Posted (Actual)

November 29, 2021

Last Update Submitted That Met QC Criteria

November 25, 2021

Last Verified

November 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

  • STAGER Study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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