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)
Dr Asmae Belhaj
Av Dr G Therasse 1
Mr Marc Bourgeois
Av Dr G Therasse 1
+32 81 42 47 98
Surveillance of Infectious Complications in patients undergoing a Vascular Surgery procedure: Prevalence, treatment, outcome
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 Committee CHU UcL Namur, 07/06/2016, ref: B039201627251
Single-centre retrospective and prospective observational cohort study
Primary study design
Secondary study design
Patient information sheet
Infectious complications of vascular surgery
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.
Primary outcome measures
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
Overall trial end date
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
Target number of participants
Participant exclusion criteria
Patients with an infectious complication following vascular surgery performed in an external center.
Recruitment start date
Recruitment end date
Countries of recruitment
Trial participating centre
CHU Godinne UCL Namur
Avenue Docteur Gaston-Therasse
CHU UCL Namur
Funding Body Type
Funding Body Subtype
Results and Publications
Publication and dissemination plan
Planned publication in a peer reviewed journal
Intention to publish date
Participant level data
Available on request
Results - basic reporting