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

NCT ID: NCT04557254

Last Updated: 2021-11-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-09-25

Study Completion Date

2021-09-15

Brief Summary

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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.

Detailed Description

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Conditions

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Infective Graft Complications

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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silver-triclosan graft implantation (SynG group)

graft

Intervention Type 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.

standard Dacron graft implantation (DacrG group)

graft

Intervention Type 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.

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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IRCCS San Raffaele

OTHER

Sponsor Role lead

Responsible Party

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Prof. Andrea Kahlberg

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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IRCCS San Raffaele Hospital

Milan, , Italy

Site Status

Countries

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Italy

References

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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.

Reference Type BACKGROUND
PMID: 26680451 (View on PubMed)

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.

Reference Type RESULT
PMID: 25608572 (View on PubMed)

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.

Reference Type DERIVED
PMID: 37943291 (View on PubMed)

Other Identifiers

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STAGER Study

Identifier Type: -

Identifier Source: org_study_id