ISRCTN ISRCTN09685290
DOI https://doi.org/10.1186/ISRCTN09685290
Secondary identifying numbers N0205157956
Submission date
30/09/2005
Registration date
30/09/2005
Last edited
07/06/2017
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

Not provided at time of registration

Contact information

Mr M. Barry
Scientific

Orthopaedic Surgery
The Royal London Hospital
Whitechapel
London
E1 1BB
United Kingdom

Phone +44 (0)20 7377 7415
Email matthew.barry@bartsandthelondon.nhs.uk

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typePrevention
Participant information sheet Not available in web format, please use the contact details to request a patient information sheet
Scientific titleHibiscrub as cleansing solution for pin site care
Study objectivesTo confirm the null hypothesis that there is no difference in the clinical effectiveness of water and hibiscrub versus the current standard of aseptic technique and Na CL 0.9% as cleansing agent for pin sites in patients with external fixators.
Ethics approval(s)Not provided at time of registration
Health condition(s) or problem(s) studiedSurgery: Orthopaedic
InterventionWater and hibiscrub versus the current standard of aseptic technique and Na CL 0.9%
Intervention typeProcedure/Surgery
Primary outcome measure1. Patient infection rate: patients with more than 2 pin site infection in any of the five visits
2. The length of the hospital stay
3. Length of time spent by nursing staff performing pin site care and equipment used
Secondary outcome measuresNot provided at time of registration
Overall study start date20/12/2004
Completion date19/12/2008

Eligibility

Participant type(s)Patient
Age groupAdult
SexBoth
Target number of participantsNot provided at time of registration
Key inclusion criteriaPatients aged over 16 with an external fixator in any of the Royal London Hospital wards - outpatients department
Key exclusion criteriaNot provided at time of registration
Date of first enrolment20/12/2004
Date of final enrolment19/12/2008

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

The Royal London Hospital
London
E1 1BB
United Kingdom

Sponsor information

Department of Health
Government

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Phone +44 (0)20 7307 2622
Email dhmail@doh.gsi.org.uk
Website http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Hospital/treatment centre

Barts and The London NHS Trust (UK)

No information available

NHS R&D Support Funding

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Editorial Notes

07/06/2017: No publications found, verifying study status with principal investigator.