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ISRCTN
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ISRCTN83184634
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ClinicalTrials.gov identifier
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Public title
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Study of the effect of platelet rich plasma (PRP) on the healing of skin grafts placed on radial forearm donor sites in patients being treated for head and neck cancer.
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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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N0013146160
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Study hypothesis
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To see if a concentrated preparation of growth factors found in your blood cells speeds up the healing of a skin graft placed at the site a skin flap has been raised from your forearm.
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Lay summary
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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 open label controlled parallel group 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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Head and neck cancers
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Participants - inclusion criteria
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New patients attending the Head and Neck Oncology clinic at Guy's Hospital with a cancer requiring surgical excision and reconstruction with a skin only radial forearm flap will be identified and approached by an investigator who is a member of the clinical team. Those patients who chose to join the study will be randomised to the treatment and control groups.
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Participants - exclusion criteria
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Does not meet inclusion criteria
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Anticipated start date
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02/01/2004
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Anticipated end date
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02/01/2006
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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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Not provided at time of registration
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Interventions
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A Randomised Controlled Trial. New patients will be recruited from the head and neck clinic who present requiring surgical treatment of their oral cancer involving reconstruction with a skin only radial forearm flap. These patients will be randomised to a treatment group and a control group.
Treatment group PRP applied to donor site before skin graft is sutured using standard protocol.
Control group no PRP applied. It is not necessary to blind either the patients or the investigators to the treatment.
Follow-up standardised digital clinical photographs, from fixed distance with a grid, will be taken of the skin graft at 5 set post operative intervals. These will be evaluated by 2 independent clinicians blinded to the treatment groups. The primary end point is complete graft failure. The secondary end point is the degree of graft failure as a percentage of the whole flap. All patients will be monitored as per standard head and neck protocol until all wounds have healed.
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Primary outcome measure(s)
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1. Rate of healing of the skin grafts
2. Reduction of skin graft failures
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Secondary outcome measure(s)
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Not provided at time of registration
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Sources of funding
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Guy's and St. Thomas' NHS Foundation Trust (UK)
Own account
NHS R&D Support Funding
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Trial website
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Publications
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Contact name
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Prof
Mark
McGurk
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Address
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Oral Surgery
23rd Floor
Guy's Tower
Guy's Hospital
St Thomas' Street
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City/town
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London
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Zip/Postcode
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SE1 9RT
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Country
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United Kingdom
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Tel
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+44 (0)20 7188 4349
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Email
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mark.mcgurk@kcl.ac.uk
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Sponsor
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Record Provided by the NHSTCT Register - 2005 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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Fax
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+44 (0)20 7307 2623
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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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30/09/2005
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Last edited
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12/08/2009
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Date ISRCTN assigned
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30/09/2005
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