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ISRCTN
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ISRCTN70685656
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ClinicalTrials.gov identifier
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Public title
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Wound closure following hip arthroplasty
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Scientific title
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Wound closure following hip arthroplasty: a multicentre randomised controlled trial
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Acronym
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N/A
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Serial number at source
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N/A
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Study hypothesis
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We hypothesise that closing wounds, after total hip replacement, with DERMABOND® (skin glue) in addition to sutures will significantly decrease wound leakage and consequently surgical site infection rates.
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Ethics approval
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West of Scotland Research Ethics Committee pending approval as of 25/01/2010
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Study design
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Multicentre three-armed randomised trial
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Countries of recruitment
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Scotland
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Disease/condition/study domain
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Post-operative wound leakage and surgical site infection
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Participants - inclusion criteria
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1. Anyone requiring elective Total Hip Replacement at Glasgow Royal Infirmary or Royal Alexandra Hospital (Paisley)
2. Able to give informed consent
3. Aged over 18 years, either sex
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Participants - exclusion criteria
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1. Anyone with known glue allergy
2. Anyone with a coagulation disorder
3. Anyone unable to give informed consent
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Anticipated start date
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05/04/2010
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Anticipated end date
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01/04/2011
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Status of trial
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Ongoing |
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Patient information material
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Not available in web format, please use the contact details below to request a patient information sheet
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Target number of participants
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219 in three groups
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Interventions
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All subjects in each of three randomised groups will have total hip arthroplasty wounds closed in layers with absorbable sutures. Subcuticular skin closure will be performed using monofilament suture (3/0 Biosyn) to oppose the wound edges. Each group will differ in the method of wound dressing.
Group 1:
A standard absorbent dressing will be applied to the wound.
Group 2:
DERMABOND® tissue adhesive will be applied to the dry wound in multiple thin layers. The width of the application will be approximately 5 mm either side of the incision. DERMABOND® will only be applied topically and never between wound edges. A standard absorbent dressing will be applied to the wound.
Group 3:
DERMABOND® tissue adhesive will be applied to the dry wound in multiple thin layers as for Group 2. A standard large Tegaderm™ dressing will then be applied to the wound.
The wound will be dressed for several weeks post-operatively but this will vary from patient to patient. Follow up will be 3 months.
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Primary outcome measure(s)
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Wound leakage at 3 days post-operative.
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Secondary outcome measure(s)
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1. Wound complications including infection, assessed daily until patient is discharged and followed up at 3 months, and discharge, assessed daily until patient is discharged from hospital. Any discharge beyond day 4 will be classified as prolonged.
2. Time to discharge
3. Cosmetic appearance, measured using a modified Hollander Scale to assess cosmesis at 3 months post-operatively
4. Pain, measured using a visual analogue scale to assess pain daily until discharge and again at 3 months
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Sources of funding
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Glasgow Royal Infirmary (UK) - Orthopaedic Endowment Fund
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Trial website
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Publications
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Contact name
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Mr
Roland
Ingram
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Address
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Glasgow Royal Infirmary
Orthopaedics Department
GateHouse Building
Castle Street
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City/town
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Glasgow
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Zip/Postcode
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G4 0SF
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Country
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United Kingdom
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Email
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Roland.Ingram@ggc.scot.nhs.uk
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Sponsor
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NHS Greater Glasgow and Clyde (UK)
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Address
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R&D Management Office
Western Infirmary
38 Church Street
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City/town
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Glasgow
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Zip/Postcode
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G11 6NT
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Country
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United Kingdom
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Sponsor website:
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http://www.nhsggc.org.uk/content/
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Date applied
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25/01/2010
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Last edited
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05/02/2010
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Date ISRCTN assigned
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05/02/2010
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