Vascular Graft Infections (VASGRA)

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified March 2013 by University of Zurich
Sponsor:
Collaborator:
Schweizerischer Nationalfonds
Information provided by (Responsible Party):
University of Zurich
ClinicalTrials.gov Identifier:
NCT01821664
First received: March 7, 2013
Last updated: March 26, 2013
Last verified: March 2013
  Purpose

Background: Vascular grafts are increasingly implanted due to an increasing prevalence of atherosclerosis and diabetes, and about 1-6% of vascular procedures are complicated by infection. Mortality attributable to prosthetic vascular graft infections (PVGI) is high. However, there are almost no data regarding best treatment options of such complicated infections. Most recommendations are based on expert opinion and not on clinical trials or cohort observational data analyses. Evaluating infectious and other complications after vascular surgery procedures are important, and additionally, such studies may offer insights for quality improvement and improved patient outcomes. With the first aim investigators will establish an infrastructure for studying PVGI in Zurich. Investigators will take advantage of the Swissvasc registry, a central registry which collects preoperative, operative and discharge data regarding the index vascular surgical interventions. They will create a prospective observational cohort database of all patients who receive a vascular graft (peripheral, aortic, vein) at the University hospital of Zurich (VASGRA Cohort A). Patients with a PVGI will be included in VASGRA Cohort B and followed up using a flow chart with a focus on the course of this infectious complication. Additionally, investigators will establish a biobank with the collection of tissue- and blood samples of patients with PVGI. With the second aim researchers will investigate different diagnostic, clinical and therapeutic research questions nested in the VASGRA Cohort. Firstly, they will address epidemiological questions, such as: determine the incidence and outcome of complications after vascular graft placement; determine risk factors, best treatment strategies and outcome of PVGI, and determine the influence of different antibiotic regimens on the outcome of PVGI due to different bacterial pathogens. Secondly, investigators will determine the accuracy of different imaging techniques (PET/CT and MRI) for the diagnosis of PVGI, and their individual role for the assessment of treatment response. Thirdly, investigators will evaluate the bacterial diversity of vascular wound infections using 16s r-Ribonucleic acid (RNA)amplification, and investigators will explore whether this bacterial diversity does predict disease progression. Here, investigators will also study the impact of negative pressure wound therapy (NPWT) on bacterial diversity in the treatment course of PVGI. Fourthly, investigators will look for cut-off levels of relevant blood leucocytes count, C-reactive protein and procalcitonin raising suspicion of a PVGI. Lastly, investigators will look at histopathological features of excised vascular grafts. Expected value of the project: Results from the proposed study are an important contribution to the field, based on the large sample size, longitudinal design and by unifying clinical and epidemiological science. The very well characterized patient groups and the close connection between vascular surgeons, infectious disease specialists, specialists in nuclear medicine and microbiologist will help to investigate PVGI in depths. Investigators hope to be able to develop guidelines regarding best diagnostic modalities and treatment options in case of vascular graft infections. In the future we plan to examine bacteria retrieved from the PVGI in the laboratory in detail. The recovered bacteria will be examined for antimicrobial susceptibility and their capability to form biofilms. Furthermore investigators will examine how bacterial recovery form explanted grafts could be optimized.


Condition Intervention
Prosthetic Vascular Graft Infection
Device: Prosthetic vascular graft

Study Type: Observational [Patient Registry]
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 10 Years
Official Title: Vascular Graft Infections - Epidemiology, Best Treatment Options, Imaging Modalities and Impact of Negative Pressure Wound Therapy

Further study details as provided by University of Zurich:

Primary Outcome Measures:
  • Vascular graft infection [ Time Frame: within 10 years ] [ Designated as safety issue: No ]
    Persons are followed up after vascular graft surgery.


Secondary Outcome Measures:
  • Bleeding [ Time Frame: 10 years ] [ Designated as safety issue: No ]
  • Foreign body reaction [ Time Frame: 10 years ] [ Designated as safety issue: No ]
  • All cause- mortality [ Time Frame: 10 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 1800
Study Start Date: April 2013
Estimated Study Completion Date: March 2023
Estimated Primary Completion Date: March 2023 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Prosthetic vascular graft implantation, follow up Device: Prosthetic vascular graft
Implantation of a prosthetic vascular graft
Other Names:
  • Valsalva Graft, Gelwave TM
  • Subclavia Graft, Gelwave TM
  • Longer Ante-Flo Offset branch, Gelwave TM
  • Lupiae Branched Graft, Gelwave TM
  • 4 Branched Plexus, Gelwave TM
  • Bifurcate, Gelwave TM soft
  • Subclavia Graft straight, Gelwave TM soft
  • Intergard woven straight, Intervascular "Maquet Getinge Group"
  • Intergard woven hemabridge, Intervascular "Maquet Getinge Group"
  • Intergard woven Aortic Arch, Intervascular "Maquet Getinge Group"
  • Intergard Silver Knitted Bifurcation, Intervascular "Maquet Getinge Group"
  • Intergard Silver Knitted Straight, Intervascular "Maquet Getinge Group"
  • InterGard TM knitted Bifurcation, Intervascular "Maquet Getinge Group"
  • FlowLine Bipore r Heparin ePTFE Vascular Graft, Jotec r GmbH
  • ePTFE Vascular Graft Regular Wall flex, IMPRA r
  • ePTFE Vascular Graft Thin Wall flex, IMPRA r
  • ePTFE Vascular Graft Regular Wall straight, IMPRA r
  • Gore-Tex Stretch Vascular Graft standard Wall Eptfe, W.L. Gore & Associates, Inl

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

All patients with a vascular surgery at the University hospital will be included in the study.

Criteria

Inclusion criteria:

Control patients:

- Vascular graft surgery (peripheral, aortic, vein)

Case patients:

  • Patients with previous primary implantation of an aortic or peripheral vascular implant and suspicion of PVGI
  • Age >18 years
  • Written informed consent

Exclusion criteria:

  • Drug or alcohol abuse
  • Involvement in a conflicting clinical trial (investigational drug)
  • Inability to follow the procedures of the cohort, e.g. due to language problems, psychological disorders or dementia of the subject
  • Known or suspected non-compliance
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01821664

Contacts
Contact: Barbara Hasse, MD +41 (0)44 255 11 11 barbara.hasse@usz.ch

Locations
Switzerland
University Hospital Zurich, Div of Infectious Diseases and Hospital Epidemiology Not yet recruiting
Zurich, ZH, Switzerland, 8091
Sponsors and Collaborators
University of Zurich
Schweizerischer Nationalfonds
Investigators
Principal Investigator: Barbara Hasse, MD University Hospital Zurich, Div of Infectious Diseases and Hospital Epidemiology
  More Information

No publications provided

Responsible Party: University of Zurich
ClinicalTrials.gov Identifier: NCT01821664     History of Changes
Other Study ID Numbers: KEK-ZH-Nr. 2012-0583
Study First Received: March 7, 2013
Last Updated: March 26, 2013
Health Authority: Switzerland: Swissmedic

Keywords provided by University of Zurich:
Prosthetic vascular graft infection
negative pressure wound therapy
microbiology
antimicrobial therapy

ClinicalTrials.gov processed this record on July 22, 2014