ISRCTN ISRCTN09685290
DOI https://doi.org/10.1186/ISRCTN09685290
Protocol serial number N0205157956
Sponsor Department of Health
Funders Barts and The London NHS Trust (UK), NHS R&D Support Funding
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

Primary study designInterventional
Study designRandomised controlled trial
Secondary study designRandomised controlled trial
Study type Participant 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 measure(s)

1. 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

Key secondary outcome measure(s)

Not provided at time of registration

Completion date19/12/2008

Eligibility

Participant type(s)Patient
Age groupAdult
SexAll
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

  • United Kingdom
  • England

Study participating centre

The Royal London Hospital
London
E1 1BB
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Participant information sheet Participant information sheet 11/11/2025 11/11/2025 No Yes

Editorial Notes

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