Condition category
Infections and Infestations
Date applied
12/09/2003
Date assigned
12/09/2003
Last edited
15/02/2013
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 B Venkateswaran

ORCID ID

Contact details

Orthopaedics
Bradford Royal Infirmary
Duckworth Lane
Bradford
BD9 6RJ
United Kingdom
+44 (0)1274 734744 bleep 446

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0050111063

Study information

Scientific title

Acronym

Study hypothesis

Does the use of foot pumps reduce:
1. The incidence of pin tract sepsis?
2. The morbidity of established infection?

Ethics approval

Not provided at time of registration

Study design

A prospective randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Quality of life

Patient information sheet

Condition

Infections and Infestations: Pin tract infections

Intervention

A prospective randomised controlled trial/case note review. Randomise patients with external fixators to two groups - 1. with and 2. without foot pump. A minimum period of 72 h of foot pump usage is aimed at to see any changes. As well as this, both groups will have the normal routine of treatment and prevention of infection at the pin sites. This is already in place. They are followed up till their usual first clinic visit to observe effect on the pin site.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Establishment of status of pin site as infected or not infected on clinical examination both at discharge and first clinic visit.

Secondary outcome measures

Not provided at time of registration

Overall trial start date

27/05/2002

Overall trial end date

27/05/2003

Reason abandoned

Eligibility

Participant inclusion criteria

All adult patients admitted to the orthopaedic wards with an external fixator to the lower limb. Patients would have to have had a fresh procedure and should have had the external fixator applied during the current admission.

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Not provided at time of registration

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

27/05/2002

Recruitment end date

27/05/2003

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Orthopaedics
Bradford
BD9 6RJ
United Kingdom

Sponsor information

Organisation

Department of Health (UK)

Sponsor details

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Sponsor type

Government

Website

http://www.doh.gov.uk

Funders

Funder type

Industry

Funder name

Huntleigh Healthcare (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

Publication citations

Additional files

Editorial Notes