VASGRA: Vascular Graft Infections

Sponsor

University of Zurich (Other)

Overall Status

Recruiting

CT.gov ID

NCT01821664

Collaborator

Schweizerischer Nationalfonds (Other)

1,800

Enrollment

Location

118

Duration (Months)

15.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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 or Disease	Intervention/Treatment	Phase
Prosthetic Vascular Graft Infection	Device: Prosthetic vascular graft

Study Design

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

1800 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Vascular Graft Infections - Epidemiology, Best Treatment Options, Imaging Modalities and Impact of Negative Pressure Wound Therapy

Study Start Date :

May 1, 2013

Anticipated Primary Completion Date :

Mar 1, 2023

Anticipated Study Completion Date :

Mar 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
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

Arm

Intervention/Treatment

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

Outcome Measures

Primary Outcome Measures

Vascular graft infection [within 10 years]
Persons are followed up after vascular graft surgery.

Secondary Outcome Measures

Bleeding [10 years]
Foreign body reaction [10 years]
All cause- mortality [10 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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