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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04557254
Enrollment
200
Registered
2020-09-21
Start date
2020-09-25
Completion date
2021-09-15
Last updated
2021-11-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infective Graft Complications

Brief summary

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.

Interventions

DEVICEgraft

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.

Sponsors

IRCCS San Raffaele
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Number of patients without infectious complications30 daysfreedom from infectious complications (percentage)

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 10, 2026