Condition category
Surgery
Date applied
30/09/2004
Date assigned
30/09/2004
Last edited
05/01/2010
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Mr Ian Chetter

ORCID ID

Contact details

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

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0084125086

Study information

Scientific title

A double blinded randomised controlled trial of antibiotic prophylaxis in varicose vein surgery

Acronym

Study hypothesis

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

Added 13/02/2009: Hull and East Riding Local Research Ethics Committee gave approval on the 23rd September 2002 (ref: LREC/08/02/135)

Study design

Double blinded randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

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

Phase

Not Applicable

Drug names

Primary outcome measures

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 trial start date

09/04/2003

Overall trial end date

01/06/2006

Reason abandoned

Eligibility

Participant 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.

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

572

Participant 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

Recruitment start date

09/04/2003

Recruitment end date

01/06/2006

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Dept of Vascular Surgery
Hull
HU3 2JZ
United Kingdom

Sponsor information

Organisation

Department of Health

Sponsor details

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Sponsor type

Government

Website

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

Funders

Funder type

Government

Funder name

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

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20013927

Publication citations

  1. Results

    Mekako AI, Chetter IC, Coughlin PA, Hatfield J, McCollum PT, , Randomized clinical trial of co-amoxiclav versus no antibiotic prophylaxis in varicose vein surgery., Br J Surg, 2010, 97, 1, 29-36, doi: 10.1002/bjs.6849.

Additional files

Editorial Notes