A trial comparing skin preparation regimens in primary knee arthroscopy

ISRCTN	ISRCTN64955840
DOI	https://doi.org/10.1186/ISRCTN64955840
Secondary identifying numbers	11/NW/0222

Submission date: 19/10/2011
Registration date: 09/10/2014
Last edited: 19/05/2017

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

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

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

Contact information

Mr Glyn Thomas
Scientific

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

Study information

Study design	Randomised trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Screening
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title	A randomised trial comparing the efficacy of skin preparation regimens in native knee arthroscopy
Study objectives	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(s)	NRES committee North West - Liverpool Central, 23/08/2011, ref: 11/NW/0222
Health condition(s) or problem(s) studied	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
Primary outcome measure	Microbiological evidence of growth
Secondary outcome measures	Clinical evidence of infection
Overall study start date	01/12/2011
Completion date	01/12/2012

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	200 patients
Key inclusion criteria	1. Age over 18 years 2. Patients competent to consent for themselves 3. Patients undergoing primary arthroscopy as a routine out patient
Key exclusion criteria	1. Previous joint arthroplasty on affected limb 2. Known infected native joint 3. Concurrent infection or long term antibiotic prescription for infection
Date of first enrolment	01/12/2011
Date of final enrolment	01/12/2012

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Wirral University Teaching Hospital

Wirral
CH49 5PE
United Kingdom

Sponsor information

Wirral University Teaching Hospital (UK)
Hospital/treatment centre

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

"ROR"	https://ror.org/05cv4zg26

Funders

Funder type

Hospital/treatment centre

Wirral University Teaching Hospital (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

Editorial Notes

19/05/2017: No publications found in PubMed, verifying study status with principal investigator.