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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| silver-triclosan graft implantation (SynG group) |
| ||
| standard Dacron graft implantation (DacrG group) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| graft | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of patients without infectious complications | freedom from infectious complications (percentage) | 30 days |
| Number of patients without infectious complications | freedom from infectious complications (percentage) | 5 years |
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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
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Patients who have surgery aortic repair in which it was used a prosthesis containing antimicrobial agents or a standard vascular prosthesis (Dacron)
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| IRCCS San Raffaele Hospital | Milan | 20132 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26680451 | Background | 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. | |
| 25608572 | Result |
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| ID | Term |
|---|---|
| D014180 | Transplantation |
| ID | Term |
|---|---|
| D013514 | Surgical Procedures, Operative |
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|
| 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. |
| 37943291 | Derived | Kahlberg A, Bilman V, Bugna C, Rinaldi E, Mascia D, Loschi D, Chiesa R, Melissano G. Silver acetate and Triclosan Antimicrobial Graft Evaluation for surgical Repair of aortic disease (STAGER Study). Int Angiol. 2023 Oct;42(5):402-411. doi: 10.23736/S0392-9590.23.05101-5. Epub 2023 Nov 9. |