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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.
ISRCTN ISRCTN83184634
DOI 10.1186/ISRCTN83184634
ClinicalTrials.gov identifier
EudraCT number
Public title 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.
Scientific title
Acronym N/A
Serial number at source N0013146160
Study hypothesis 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.
Lay summary Not provided at time of registration
Ethics approval Not provided at time of registration
Study design Randomised open label controlled parallel group trial
Countries of recruitment United Kingdom
Disease/condition/study domain Head and neck cancers
Participants - inclusion criteria 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.
Participants - exclusion criteria Does not meet inclusion criteria
Anticipated start date 02/01/2004
Anticipated end date 02/01/2006
Status of trial Completed
Patient information material Not available in web format, please use the contact details below to request a patient information sheet
Target number of participants Not provided at time of registration
Interventions 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.
Primary outcome measure(s) 1. Rate of healing of the skin grafts
2. Reduction of skin graft failures
Secondary outcome measure(s) Not provided at time of registration
Sources of funding Guy's and St. Thomas' NHS Foundation Trust (UK)
Own account
NHS R&D Support Funding
Trial website
Publications
Contact name Prof  Mark  McGurk
  Address Oral Surgery
23rd Floor
Guy's Tower
Guy's Hospital
St Thomas' Street
  City/town London
  Zip/Postcode SE1 9RT
  Country United Kingdom
  Tel +44 (0)20 7188 4349
  Email mark.mcgurk@kcl.ac.uk
Sponsor Record Provided by the NHSTCT Register - 2005 Update - Department of Health (UK)
  Address The Department of Health
Richmond House
79 Whitehall
  City/town London
  Zip/Postcode SW1A 2NL
  Country United Kingdom
  Tel +44 (0)20 7307 2622
  Fax +44 (0)20 7307 2623
  Email dhmail@doh.gsi.org.uk
  Sponsor website: http://www.dh.gov.uk/Home/fs/en
Date applied 30/09/2005
Last edited 17/05/2012
Date ISRCTN assigned 30/09/2005
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