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Effect of methotrexate in post-operative wound healing in rheumatoid patients undergoing foot and ankle surgery
ISRCTN ISRCTN86123456
DOI 10.1186/ISRCTN86123456
ClinicalTrials.gov identifier
EudraCT number
Public title Effect of methotrexate in post-operative wound healing in rheumatoid patients undergoing foot and ankle surgery
Scientific title
Acronym N/A
Serial number at source N0280141217
Study hypothesis Does methotrexate affect post-operative wound healing in rheumatoid patients undergoing foot and ankle surgery?
Lay summary
Ethics approval Not provided at time of registration
Study design Randomised controlled trial
Countries of recruitment United Kingdom
Disease/condition/study domain Surgery: Foot and ankle
Participants - inclusion criteria Rheumatoid patients on methotrexate therapy undergoing foot and ankle surgery.
Participants - exclusion criteria 1. Ongoing use of other immunosuppression agents.
2. Localised infection pre-operatively.
Anticipated start date 01/05/2004
Anticipated end date 01/05/2005
Status of trial Stopped
Patient information material
Target number of participants Sample of 200 patients in each group.
Interventions Group A: continuous methotrexate therapy for two weeks during perioperative period
Group B: omit methotrexate therapy for two weeks during perioperative period

Added September 2008: trial stopped due to poor recruitment.
Primary outcome measure(s) 1. Rate of wound infection
2. Patient pain levels
Secondary outcome measure(s) Not provided at time of registration
Sources of funding Wirral Hospitals NHS Trust (UK), NHS R&D Support Funding
Trial website
Publications
Contact name Mr  Nick  Emms
  Address Department of Orthopaedics
Wirral Hospital NHS Trust
Arrowe Park Road
Upton
  City/town Wirral
  Zip/Postcode CH49 5PE
  Country United Kingdom
  Tel +44 (0)151 678 5111
  Fax +44 (0)151 678 2602
  Email nick.emms@ukonline.co.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 12/04/2011
Date ISRCTN assigned 30/09/2005
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