Antibiotic prophylaxis in varicose vein surgery

ISRCTN	ISRCTN12467340
DOI	https://doi.org/10.1186/ISRCTN12467340
Secondary identifying numbers	N0084125086

Submission date: 30/09/2004
Registration date: 30/09/2004
Last edited: 05/01/2010

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Surgery

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Mr Ian Chetter
Scientific

Dept of Vascular Surgery
Hull Royal Infirmary
Hull
HU3 2JZ
United Kingdom

Study information

Study design	Double blinded randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title	A double blinded randomised controlled trial of antibiotic prophylaxis in varicose vein surgery
Study objectives	To compare antibiotic prophylaxis with no antibiotic, with primary endpoint being the rate of wound infection. Please note that as of 13/02/2009 this record was extensively updated. All amendments can be found in the relevant field under the above update date.
Ethics approval(s)	Added 13/02/2009: Hull and East Riding Local Research Ethics Committee gave approval on the 23rd September 2002 (ref: LREC/08/02/135)
Health condition(s) or problem(s) studied	Surgery: Varicose vein
Intervention	1. Antibiotics (Augmentin 1.2 g) 2. No antibiotics The treatment was a one-off treatment (varicose vein surgery), which lasted a range of 44 - 65 minutes. Patients were seen once at 14 days post-operation.
Intervention type	Procedure/Surgery
Primary outcome measure	Added 13/02/2009: The degree of wound complications, determined by an adapted version of the ASEPSIS wound scoring system.
Secondary outcome measures	Added 13/02/2009: 1. Visit to the General Practitioner for a wound-related problem 2. The requirement of antibiotics in the post-operative period for a perceived wound infection
Overall study start date	09/04/2003
Completion date	01/06/2006

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	572
Key inclusion criteria	Added 13/02/2009: 1. Aged 18 years or older, either sex 2. Undergoing groin surgery for varicose veins. All patients with varicosities of the greater saphenous vein (GSV) listed for saphenofemoral ligation, stripping of the GSV and phlebectomies were eligible to enter the trial.
Key exclusion criteria	Added 13/02/2009: 1. Patients whose surgery did not include a groin incision 2. Patients below the age of 18 years 3. Pregnancy or lactation 4. Penicillin allergy 5. Receiving antibiotics for other indications
Date of first enrolment	09/04/2003
Date of final enrolment	01/06/2006

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Dept of Vascular Surgery

Hull
HU3 2JZ
United Kingdom

Sponsor information

Department of Health
Government

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Website	http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Government

The North and South Bank Research and Development Consortium (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/01/2010		Yes	No