Condition category
Surgery
Date applied
19/10/2011
Date assigned
09/10/2014
Last edited
09/10/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Knee arthroscopy is a type of keyhole surgery where a telescope (arthroscope) is used to investigate and diagnose knee problems such as inflammation or injury. An antibacterial skin cleaner is used to prepare the skin before the operation. The aim of this study is to see if there is any difference in effectiveness between two antibacterial skin cleaners (chlorhexidine or betadine) and the number of times they are used.

Who can participate?
Patients aged over 18 undergoing knee arthroscopy.

What does the study involve?
Participants will be randomly allocated to be treated with either chlorhexidine single preparation, chlorhexidine double preparation, betadine single preparation or betadine double preparation. The first skin preparation is applied by a trained nurse on the ward who will then cover the knee in a sterile dressing. The second preparation is applied by the surgeon when the patient is asleep just before arthroscopy. When the skin preparation is dry, a small skin swab (cotton wool bud) will be taken from the area where the arthroscope is entering. This is sent to the laboratory for tests.

What are the possible benefits and risks of participating in the study?
There will be no difference with treatment for the patients. The study does not interfere with their arthroscopy and has been discussed with their surgeon. There are no immediate gains from entering the trial for each patient and their care will not be affected. There are no specific new side effects from the study as the skin preparations (chlorhexidine and betadine) are already used daily.

Where is the study run from?
The study will take place at Arrowe Park Hospital and Clatterbridge Hospital (UK).

When is the study starting and how long is it expected to run for?
The study ran from December 2011 to December 2012.

Who is funding the study?
The study is being funded by Wirral University Hospital NHS Trust (UK).

Who is the main contact?
Mr Glyn Thomas
Tel: +44 (0)1516785111

Trial website

Contact information

Type

Scientific

Primary contact

Mr Glyn Thomas

ORCID ID

Contact details

Wirral University Teaching Hospital
Arrowe Park Road
Upton
Wirral
CH49 5PE
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

11/NW/0222

Study information

Scientific title

A randomised trial comparing the efficacy of skin preparation regimens in native knee arthroscopy

Acronym

Study hypothesis

We hypothesise that there is no clinical or microbiological difference in a double or single preparation with either chlorhexidine or betadine when concerning primary knee arthroscopy

Ethics approval

NRES committee North West - Liverpool Central, 23/08/2011, ref: 11/NW/0222

Study design

Randomised trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Screening

Patient information sheet

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

Condition

Orthopaedics/knee arthroscopy

Intervention

Either chlorhexidine or betadine preparation (single or double preparation):
1. Chlorhexidine single preparation
2. Chlorhexidine double preparation
3. Betadine single preparation
4. Betadine double preparation

Intervention type

Procedure/Surgery

Phase

Not Applicable

Drug names

Primary outcome measures

Microbiological evidence of growth

Secondary outcome measures

Clinical evidence of infection

Overall trial start date

01/12/2011

Overall trial end date

01/12/2012

Reason abandoned

Eligibility

Participant inclusion criteria

1. Age over 18 years
2. Patients competent to consent for themselves
3. Patients undergoing primary arthroscopy as a routine out patient

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

200 patients

Participant exclusion criteria

1. Previous joint arthroplasty on affected limb
2. Known infected native joint
3. Concurrent infection or long term antibiotic prescription for infection

Recruitment start date

01/12/2011

Recruitment end date

01/12/2012

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Wirral University Teaching Hospital
Wirral
CH49 5PE
United Kingdom

Sponsor information

Organisation

Wirral University Teaching Hospital (UK)

Sponsor details

c/o Professor Roderick Owen
Research and development dept
Arrowe Park Road
Upton
Wirral
CH49 5PE
United Kingdom

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Hospital/treatment centre

Funder name

Wirral University Teaching Hospital (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

Publication citations

Additional files

Editorial Notes