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ISRCTN
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ISRCTN54949546
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DOI
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10.1186/ISRCTN54949546
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ClinicalTrials.gov identifier
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EudraCT number
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Public title
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The effect of pre-operative warming on wound infection rates after clean surgery
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Scientific title
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Laser doppler flowmetry of skin circulation to measure the effects of using two warming therapies: a randomised clinical trial of surgical patients
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Acronym
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N/A
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Serial number at source
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AP0728
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Study hypothesis
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To assess whether warming patients before short duration, clean surgery will reduce infection rates.
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Lay summary
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Ethics approval
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No ethics approval information required 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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Infection during surgery
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Participants - inclusion criteria
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1. Patients having clean breast, varicose vein or hernia surgery
Added as of 07/01/2010:
2. Surgery results in a scar longer than 3 cm in length
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Participants - exclusion criteria
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Added as of 07/01/2010:
1. Under the age of 18 years
2. Pregnant
3. Taking long-term oral steroids
4. Received radiotherapy (to the incision site) or chemotherapy in the last 4 weeks
5. Had an infection at the time of surgery
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Anticipated start date
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01/01/2001
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Anticipated end date
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31/12/2001
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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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421
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Interventions
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Patients were randomised to one of three groups:
1. Standard treatment - no warming
2. Local warming - a minimum of 30 minutes localised warming to the potential incision site using a waming dressing
3. Systemic warming - a minimum of 30 minutes warming to the whole body using a warm blown air blanket
Both warming devices were applied prior to surgery. A cohort of patients had laser doppler and TcPO2 recordings taken prior to warming, after warming and after surgery.
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Primary outcome measure(s)
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Wound infection; masked outcome assessments made at 2 and 6 weeks
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Secondary outcome measure(s)
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Added as of 07/01/2010:
1. Skin preparation; masked outcome assessments made at 2 and 6 weeks
2. Length of operation; masked outcome assessments made at 2 and 6 weeks
3. Administration of prophylactic antibiotics; masked outcome assessments made at 2 and 6 weeks
4. Experience of the operating surgeon; masked outcome assessments made at 2 and 6 weeks
5. Core temperature, measured before any treatment, after any warming, and after surgery
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Sources of funding
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Action Medical Research (UK)
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Trial website
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Publications
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2001 results in http://www.ncbi.nlm.nih.gov/pubmed/11567703
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Contact name
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Mr
Andrew
Melling
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Address
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Professorial Unit of Surgery
North Tees and Hartlepool NHS Trust
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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Tel
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+44 (0)1642 624087
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Fax
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+44 (0)1642 624165
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Email
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AndyMelling@compuserve.com
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Sponsor
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Action Medical Research (UK)
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Address
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Vincent House
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City/town
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Horsham West Sussex
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Zip/Postcode
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RH12 2DP
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Country
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United Kingdom
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Tel
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+44 (0)1403 210 406
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Fax
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+44 (0)1403 210 541
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Email
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info@actionresearch.co.uk
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Sponsor website:
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http://www.action.org.uk/
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Date applied
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01/03/2001
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Last edited
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07/01/2010
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Date ISRCTN assigned
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01/03/2001
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