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ISRCTN
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ISRCTN59897148
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ClinicalTrials.gov identifier
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Public title
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The effects on post-operative pain of a warming dressing applied after hernia surgery
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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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N0159119156
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Study hypothesis
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The application of warmth to an area has traditionally been linked with reduction in pain. In this study this theory will be tested. Localised warming to the wound area will increase blood flow and therefore provide more oxygen to the wound. The increase in blood flow and post-operative tissue oxygenation in the wound area may help to reduce post-operative pain.
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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 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-operative pain
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Participants - inclusion criteria
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Patients having hernia sugery (n = 180).
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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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01/09/2002
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Anticipated end date
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31/12/2004
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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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180
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Interventions
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Group A:
Standard treatment (no warming)
Group B:
Two hours of postoperative warming to the wound immediately after surgery and then the patients warm their wounds twice a day for the first three postoperative days at home. An exothermic warming pad that adheres to the wound dressing provides the warmth
Pain scores are recorded for the first four hours after surgery and then over the next two weeks by the patient. Wounds are observed independently and healing is assessed at weeks two and six.
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Primary outcome measure(s)
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1. Post-operative pain scores
2. Quality of life
3. Wound healing
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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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North Tees and Hartlepool NHS Foundation Trust (UK)
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Trial website
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Publications
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1. 2006 results in http://www.ncbi.nlm.nih.gov/pubmed/16550663
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Contact name
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Mr
Andrew
Melling
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Address
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Clinical Research Nurse
Professorial Unit of Surgery
North Tees General Hospital
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City/town
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Stockton-on-Tees
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Zip/Postcode
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TS19 8PE
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Country
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United Kingdom
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Sponsor
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Record provided by the NHS Trusts Clinical Trials Register - 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)207 307 2622
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Fax
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+44 (0)207 307 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.doh.gov.uk
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Date applied
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12/09/2003
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Last edited
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09/02/2011
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Date ISRCTN assigned
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12/09/2003
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