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
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
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