Infectious complications following vascular surgery: Retrospective data analysis and prospective surveillance implementation in a tertiary referral center

ISRCTN	ISRCTN57519051
DOI	https://doi.org/10.1186/ISRCTN57519051
Secondary identifying numbers	N/A

Submission date: 08/01/2016
Registration date: 13/01/2016
Last edited: 27/06/2016

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Infections and Infestations

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

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

Contact information

Dr Asmae Belhaj
Scientific

CHU Mont-Godinne
Av Dr G Therasse 1
Godinne
5530
Belgium

Mr Marc Bourgeois
Public

CHU Mont-Godinne
Av Dr G Therasse 1
Godinne
5530
Belgium

Phone	+32 81 42 47 98
Email	marc.bourgeois@uclouvain.be

Study information

Study design	Single-centre retrospective and prospective observational cohort study
Primary study design	Observational
Secondary study design	Cohort study
Study setting(s)	Hospital
Study type	Prevention
Participant information sheet	N/A
Scientific title	Surveillance of Infectious Complications in patients undergoing a Vascular Surgery procedure: Prevalence, treatment, outcome
Study acronym	IC-f-VS
Study objectives	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(s)	Ethics Committee CHU UcL Namur, 07/06/2016, ref: B039201627251
Health condition(s) or problem(s) studied	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
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 study start date	01/01/2016
Completion date	30/06/2017

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	300
Key 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
Key exclusion criteria	Patients with an infectious complication following vascular surgery performed in an external center.
Date of first enrolment	01/01/2016
Date of final enrolment	31/12/2016

Locations

Countries of recruitment

Belgium

Study participating centre

CHU Godinne UCL Namur

Avenue Docteur Gaston-Therasse
Yvoir
5530
Belgium

Sponsor information

CHU Mont-Godinne
Hospital/treatment centre

Av Dr G Therasse 1
Godinne
5530
Belgium

"ROR"	https://ror.org/00ntbvq76

Funders

Funder type

Hospital/treatment centre

CHU UCL Namur

No information available

Results and Publications

Intention to publish date	30/09/2017
Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Available on request
Publication and dissemination plan	Planned publication in a peer reviewed journal
IPD sharing plan

Editorial Notes

12/05/2016: Ethics approval information added.