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ISRCTN
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ISRCTN05011819
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ClinicalTrials.gov identifier
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Public title
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A comparative study of the effects of absorbable and non-absorbable sutures on wound healing - a prospective randomised clinical study
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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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N0436146690
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Study hypothesis
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To compare and evaluate the outcome of elective surgical wound repair in the hand using absorbable and non-absorbable suture materials, in terms of wound infection, scarring, erythema and dehiscence. To evaluate the outcome of wound healing in terms of patient satisfaction and comfort.
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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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Injury, Occupational Diseases, Poisoning: Wound healing
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Participants - inclusion criteria
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This prospective randomized clinical study will be carried out on 50 patients undergoing standard elective carpal tunnel release under local anaesthetic, in the hand surgery day unit at Leeds St. James' Hospital (under the care of the plastic surgical unit).
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Participants - exclusion criteria
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Patients having re-do surgery, patients undergoing combined procedures, patients under the care of the orthopaedic hand surgeons, patient with diabetes, patients known to be steroids or immuno-suppressants
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Anticipated start date
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01/10/2003
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Anticipated end date
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01/10/2004
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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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50
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Interventions
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Randomised controlled trial; Before-after trial
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Primary outcome measure(s)
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The wounds will be assessed for quality of the scar ie erythema, scarring-hypertrophy and spread, and stitch marks. The upper and lower halves of each wound will be assessed separately. The assessor will not be told which half of the wound was closed using the prolene suture. The patients will also be asked to fill in short questionnaire relating to discomfort to stitch removal and any difference noticed by the patient within each half of the wound in the three/six month post of period.
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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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Leeds Teaching Hospitals NHS Trust
NHS Research and Development Support Funding
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Trial website
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Publications
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Contact name
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Miss
S
Jivan
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Address
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Department of Plastic Surgery
Chancellor Wing
Beckett Street
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City/town
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Leeds
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Zip/Postcode
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LS9 7TF
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Country
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United Kingdom
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Tel
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+44
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Fax
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+44
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Email
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Drsjivan@hotmail.com
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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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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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27/07/2006
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Date ISRCTN assigned
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30/09/2005
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