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

Completed

• Conditions: Infective Graft Complications
• Interventions: Device: graft

• Registration Number: NCT04557254
• Lead Sponsor: IRCCS San Raffaele

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-09-08
• Study First Submitted QC: 2020-09-15
• Study First Posted: 2020-09-21
• Study Start: 2020-09-25
• Primary Completion: 2021-08-31
• Study Completion: 2021-09-15
• Status Verified: 2021-11
• Last Update Submitted: 2021-11-25
• Last Update Posted: 2021-11-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
silver-triclosan graft implantation (SynG group)	graft	-
standard Dacron graft implantation (DacrG group)	graft	-

Primary Outcome Measures

Name	Time	Method
Number of patients without infectious complications	5 years	freedom from infectious complications (percentage)

Trial Locations

Locations (1)

IRCCS San Raffaele Hospital; 🇮🇹 Milano, Italy