Clinical trial NCT04557254: Silver Acetate and Triclosan Antimicrobial Graft Evaluation for Surgical Repair of Aortic Disease
Official title: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Infective Graft Complications
Lead sponsor: IRCCS San Raffaele
Sponsor class: OTHER
First posted: 2020-09-21
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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)

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.


Eligibility criteria: 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

Primary outcomes:
measure: Number of patients without infectious complications
timeFrame: 30 days
measure: Number of patients without infectious complications
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Milano
country: Italy
facility: IRCCS San Raffaele Hospital
Study officials:
References:
citation: Berard X, Stecken L, Pinaquy JB, Cazanave C, Puges M, Pereyre S, Bordenave L, M'Zali F. Comparison of the Antimicrobial Properties of Silver Impregnated Vascular Grafts with and without Triclosan. Eur J Vasc Endovasc Surg. 2016 Feb;51(2):285-92. doi: 10.1016/j.ejvs.2015.10.016. Epub 2015 Dec 9.
citation: Kahlberg A, Melissano G, Tshomba Y, Leopardi M, Chiesa R. Strategies to treat thoracic aortitis and infected aortic grafts. J Cardiovasc Surg (Torino). 2015 Apr;56(2):269-80. Epub 2015 Jan 22.