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ISRCTN
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ISRCTN46568273
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ClinicalTrials.gov identifier
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Public title
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The effect of nasal mupirocin, prior to percutaneous endoscopic gastrostomy (PEG), upon peristomal colonisation and infection
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Scientific title
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Acronym
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N/A
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Serial number at source
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N0547127258
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Study hypothesis
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Does the treatment, nasal mupirocin, have an effect on peristomal infection rate following percutaneous endoscopic gastrostomy (PEG) placement?
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Lay summary
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Not provided at time of registration
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Ethics approval
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Not provided at time of registration
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Study design
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Randomised controlled trial
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Post-percutaneous endoscopic gastrostomy sepsis
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Participants - inclusion criteria
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Pilot study of 20 patients recruited, pilot study of 10 controls.
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Participants - exclusion criteria
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Not provided at time of registration
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Anticipated start date
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01/06/2003
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Anticipated end date
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01/12/2003
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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30
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Interventions
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Nasal mupirocin versus standard care (no prophylactic antibiotics).
Mupirocin was administered for 5 days before PEG insertion. Nasopharyngeal swabs, PEG site appearance and bacteriology were recorded up to 10 days post-PEG.
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Primary outcome measure(s)
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Pilot:
Will access the practicalities of the study design, the consistency of the scoring tool and also give an indication of the bacteriology of nasal colonisation, peristomal colonisation and infection within the proposed research setting.
Main:
The primary outcome measure is that of perstomal infection.
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Secondary outcome measure(s)
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Secondary outcomes of peristomal colonisation and risk factors for methicillin resistant staphylococcus aureus (MRSA) colonisation will also be measured.
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Sources of funding
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East Norfolk and Waveney Research Consortium (UK) - Norfolk and Norwich University Hospital/Norwich PCT
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Trial website
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Publications
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Contact name
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Mrs
Judith
McGovern
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Address
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Department of Gastroenterology
Norfolk and Norwich University Hospital NHS Trust
Colney
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City/town
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Norwich
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Zip/Postcode
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NR4 7UY
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Country
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United Kingdom
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Sponsor
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Record Provided by the NHSTCT Register - 2004 Update - Department of Health (UK)
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Address
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The Department of Health,
Richmond House,
79 Whitehall
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City/town
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London
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Zip/Postcode
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SW1A 2NL
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Country
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United Kingdom
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Tel
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+44 (0)20 7307 2622
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Email
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dhmail@doh.gsi.org.uk
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Sponsor website:
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http://www.dh.gov.uk/Home/fs/en
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Date applied
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30/09/2004
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Last edited
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25/10/2011
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Date ISRCTN assigned
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30/09/2004
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