Plain English Summary
Background and study aims
Vascular disease is a term used to describe conditions that affect the heart and blood vessels (circulatory system). One of the most common types of vascular disease is stenosis (narrowing) of veins and arteries, due to the buildup of a fatty substance called plaque. This can lead to serious problems such as heart disease and stroke, and so the treatment of vascular disease is very important. Vascular surgery is widespread across the world. One of the most common types of vascular surgery is grafting, in which a superficial vein from elsewhere in the body or a prosthetic (artificial) graft is used to redirect blood flow around a narrowed or blocked blood vessel, restoring effective circulation. One of the most common complications after vascular surgery is infection. The likelihood that a patient will develop a post-surgical infection can be affected by a number of factors, such as other diseases the patient may have (comorbidities) and the processes used in the hospital where they are treated. The aim of this study is to review charts from elective (by choice) or emergency vascular surgery patients that have been treated in CHU Godinne UCL Namur between July 2015 and December 2015 in order to find out the amount of people who have suffered post-surgical infections and what the main causes are.
Who can participate?
Adults who have had elective or emergency vascular surgery, in the second semester of 2015 or will have in 2016 at CHU Godinne UCL Namur (Belgium).
What does the study involve?
Medical notes for all patients who have had vascular surgery involving venous or prosthetic vascular grafting in the second semester of 2015 are reviewed. Additionally, the medical notes for all patients who have had vascular surgery involving venous or prosthetic vascular grafting in 2016 are also reviewed. The amount of people who have had an infectious complication are recorded, as well as their medical history and treatment plan. Six months following surgery, patient notes are re-reviewed in order to find out how well they have recovered in the long-term.
What are the possible benefits and risks of participating?
There are no direct risks or benefits to participants taking part in this study.
Where is the study run from?
CHU Godinne UCL Namur (Belgium)
When is the study starting and how long is it expected to run for?
January 2016 to June 2017
Who is funding the study?
CHU Godinne UCL Namur (Belgium)
Who is the main contact?
1. Dr Asmae Belhaj (scientific)
2. Mr Marc Borgeois (public)
marc.bourgeois@uclouvain.be
Trial website
Contact information
Type
Scientific
Primary contact
Dr Asmae Belhaj
ORCID ID
Contact details
CHU Mont-Godinne
Av Dr G Therasse 1
Godinne
5530
Belgium
Type
Public
Additional contact
Mr Marc Bourgeois
ORCID ID
Contact details
CHU Mont-Godinne
Av Dr G Therasse 1
Godinne
5530
Belgium
+32 81 42 47 98
marc.bourgeois@uclouvain.be
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Surveillance of Infectious Complications in patients undergoing a Vascular Surgery procedure: Prevalence, treatment, outcome
Acronym
IC-f-VS
Study hypothesis
The aim of this study is to evaluate our patient's preoperative medical status, and the rate, timing (early vs late) and severity of postoperative infectious complications, as well as the therapeutics management and outcomes.
Ethics approval
Ethics Committee CHU UcL Namur, 07/06/2016, ref: B039201627251
Study design
Single-centre retrospective and prospective observational cohort study
Primary study design
Observational
Secondary study design
Cohort study
Trial setting
Hospitals
Trial type
Prevention
Patient information sheet
N/A
Condition
Infectious complications of vascular surgery
Intervention
Retrospective data of patients undergoing vascular surgery will be analysed for patients with vascular surgery in semester 2/2015. Prospective data will be registered for all patients undergoing vascular surgery in 2016. Data will be evaluated with a follow-up of 6 months following the date of surgery.
Intervention type
Other
Phase
Drug names
Primary outcome measure
Infectious complication rates and severity (CDC definitions) measured by:
1. For retrospective data: reviewing of patient notes with a 6 months follow-up
2. For prospective data: ongoing medical surveillance with a 6 months follow-up
Secondary outcome measures
1. Risk factors for infectious complications are measured using statistical analysis at the end of the study
2. Evaluation of therapeutic management is compared with internal guidelines at the end of the study
3. Patient outcomes are measured (infection resolution versus recurrence, amputation, mortality) with a 6 months follow up
Overall trial start date
01/01/2016
Overall trial end date
30/06/2017
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Aged 18 years or over
2. Vascular surgery patients receiving a venous or prosthetic vascular graft
3. Undergoing elective or emergency surgery
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
300
Participant exclusion criteria
Patients with an infectious complication following vascular surgery performed in an external center.
Recruitment start date
01/01/2016
Recruitment end date
31/12/2016
Locations
Countries of recruitment
Belgium
Trial participating centre
CHU Godinne UCL Namur
Avenue Docteur Gaston-Therasse
Yvoir
5530
Belgium
Funders
Funder type
Hospital/treatment centre
Funder name
CHU UCL Namur
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Planned publication in a peer reviewed journal
Intention to publish date
30/09/2017
Participant level data
Available on request
Basic results (scientific)
Publication list