Condition category
Surgery
Date applied
30/09/2005
Date assigned
30/09/2005
Last edited
27/01/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Mr M. Barry

ORCID ID

Contact details

Orthopaedic Surgery
The Royal London Hospital
Whitechapel
London
E1 1BB
United Kingdom
+44 (0)20 7377 7415
matthew.barry@bartsandthelondon.nhs.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0205157956

Study information

Scientific title

Hibiscrub as cleansing solution for pin site care

Acronym

Study hypothesis

To 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

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Prevention

Patient information sheet

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

Condition

Surgery: Orthopaedic

Intervention

Water and hibiscrub versus the current standard of aseptic technique and Na CL 0.9%

Intervention type

Procedure/Surgery

Phase

Not Specified

Drug names

Primary outcome measures

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

Secondary outcome measures

Not provided at time of registration

Overall trial start date

20/12/2004

Overall trial end date

19/12/2008

Reason abandoned

Eligibility

Participant inclusion criteria

Patients over 16 years with an external fixator in any of the Royal London Hospital wards - outpatients department.

Participant type

Patient

Age group

Adult

Gender

Not Specified

Target number of participants

Not provided at time of registration

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

20/12/2004

Recruitment end date

19/12/2008

Locations

Countries of recruitment

United Kingdom

Trial participating centre

The Royal London Hospital
London
E1 1BB
United Kingdom

Sponsor information

Organisation

Department of Health

Sponsor details

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk

Sponsor type

Government

Website

http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Hospital/treatment centre

Funder name

Barts and The London NHS Trust (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

NHS R&D Support Funding

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