| Source of record | UK Clinical Trials Gateway |
| ISRCTN | ISRCTN03216780 |
| Date ISRCTN assigned | 12/09/2003 |
| Local reference number(s) | N0050111063 |
| Public title | The influence of venous impulse foot pumps on pin tract infections: A prospective randomised controlled trial. |
| Scientific title |
|
| Acronym | N/A |
| Disease/condition/study domain | Infections and Infestations: Pin tract infections |
| Study hypothesis | Does the use of foot pumps reduce:
1. The incidence of pin tract sepsis?
2. The morbidity of established infection? |
| Design/methodology | A prospective randomised controlled trial |
| Research ethics review | Not provided at time of registration |
| Countries of trial | United Kingdom |
| Participants - 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. |
| Participants - exclusion criteria | Not provided at time of registration |
| Patient information material |
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| Anticipated start date | 27/05/2002 |
| Anticipated end date | 27/05/2003 |
| Status of trial | Completed |
| Target number of participants | Not provided at time of registration |
| Interventions | 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. |
| Primary outcome measure(s) | Establishment of status of pin site as infected or not infected on clinical examination both at discharge and first clinic visit. |
| Secondary outcome measure(s) | Not provided at time of registration |
| Sources of funding | Huntleigh Healthcare |
| Sponsor name | Record provided by the NHS Trusts Clinical Trials Register - Department of Health (UK) |
| Sponsor details | The Department of Health
Richmond House
79 Whitehall
London
United Kingdom
SW1A 2NL |
| Sponsor telephone | +44 (0)20 7307 2622 |
| Sponsor fax | +44 (0)20 7307 2623 |
| Sponsor email | dhmail@doh.gsi.org.uk |
| Sponsor website | http://www.doh.gov.uk |
| Contact name | Mr B Venkateswaran |
| Contact details | Orthopaedics
Bradford Royal Infirmary
Duckworth Lane
Bradford
United Kingdom
BD9 6RJ |
| Contact telephone | +44 01274 734744 bleep 446 |
| Contact fax | +44 |
| More information | For more up-to-date information please go to the ISRCTN link below. |
| Link to record in ISRCTN Register | ISRCTN03216780 |
| Date last extracted from ISRCTN register | 17/04/2008 |
