NCT04557254

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
• Phase: —
• Study type: Observational
• Enrollment: 200 (actual)
• Sponsor: IRCCS San Raffaele · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Infective Graft Complications

Interventions

Type	Name	Description
DEVICE	graft	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.

Timeline

• Start date: 2020-09-25
• Primary completion: 2021-08-31
• Completion: 2021-09-15
• First posted: 2020-09-21
• Last updated: 2021-11-29

Locations

1 site across 1 country: Italy