Condition category
Infections and Infestations
Date applied
08/01/2016
Date assigned
13/01/2016
Last edited
27/06/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

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 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

01/01/2016

Overall trial end date

30/06/2017

Reason abandoned

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

Sponsor information

Organisation

CHU Mont-Godinne

Sponsor details

Av Dr G Therasse 1
Godinne
5530
Belgium

Sponsor type

Hospital/treatment centre

Website

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

12/05/2016: Ethics approval information added.