NCT04557254

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 8, 2020

Completed
13 days until next milestone

First Posted

Study publicly available on registry

September 21, 2020

Completed
4 days until next milestone

Study Start

First participant enrolled

September 25, 2020

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2021

Completed
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 15, 2021

Completed
Last Updated

November 29, 2021

Status Verified

November 1, 2021

Enrollment Period

11 months

First QC Date

September 8, 2020

Last Update Submit

November 25, 2021

Conditions

Infective Graft Complications

Outcome Measures

Primary Outcomes (2)

  • 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

Study Arms (2)

silver-triclosan graft implantation (SynG group)

Device: graft

standard Dacron graft implantation (DacrG group)

Device: graft

Interventions

graftDEVICE

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.

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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)

You may qualify if:

  • 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

You may not qualify if:

  • not present

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

IRCCS San Raffaele Hospital

Milan, 20132, Italy

Location

Related Publications (3)

  • 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.

    PMID: 26680451BACKGROUND

  • 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.

    PMID: 25608572RESULT

  • 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.

    PMID: 37943291DERIVED

MeSH Terms

Interventions

Transplantation

Intervention Hierarchy (Ancestors)

Surgical Procedures, Operative

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 8, 2020

First Posted

September 21, 2020

Study Start

September 25, 2020

Primary Completion

August 31, 2021

Study Completion

September 15, 2021

Last Updated

November 29, 2021

Record last verified: 2021-11

Locations

IT(1)