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ISRCTN
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ISRCTN35311675
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ClinicalTrials.gov identifier
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Public title
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Topical zinc oxide for open pilonidal sinus wounds: a randomised, double-blind, placebo-controlled multicentre trial
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Scientific title
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Acronym
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ZÅRSTUDIET
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Serial number at source
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N/A
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Study hypothesis
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Locally applied zinc oxide (ZnO) may be beneficial for various types of human wounds. This randomised, double-blind, placebo-controlled multicentre trial compared the effect of topical ZnO with placebo under moist conditions on the healing of excisional wounds following surgical removal of the pilonidal sinus.
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Lay summary
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Ethics approval
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No ethics 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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Denmark
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Disease/condition/study domain
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Pilonidal excisional wound
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Participants - inclusion criteria
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Patients, 18 years or older, with a first-episode of pilonidal abscess requiring surgery are included after giving their written informed consent.
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Participants - exclusion criteria
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Previous pilonidal surgery, hypersensitivity to zinc, dementia, insufficiency in Danish, pregnancy or lactation.
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Anticipated start date
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01/02/2002
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Anticipated end date
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01/05/2004
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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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75
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Interventions
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Zinc oxide and polyvinylpyrrolidone versus polyvinylpyrrolidone alone
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Primary outcome measure(s)
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Time to wound closure in days, defined by complete coverage of the
wound with visible epithelium.
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Secondary outcome measure(s)
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Secondary outcomes were:
1. Postoperative antibiotic treatment
2. Re-operations
3. Pain intensity
4. Adverse events
Tertiary outcomes were:
1. Serum-zinc levels
2. Sick leave
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Sources of funding
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Apotekerfonden 1991, Abigo Medical AB
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Trial website
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Publications
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2006 results in http://www.ncbi.nlm.nih.gov/pubmed/17014663
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Contact name
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Dr
Magnus
Ågren
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Address
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Department of Surgery K
Bispebjerg Hospital
University of Copenhagen
Bispebjerg Bakke 23
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City/town
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Copenhagen
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Zip/Postcode
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DK-2400
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Country
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Denmark
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Tel
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+45 35316493
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Fax
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+45 35312981
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Email
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magnus.agren@get2net.dk
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Sponsor
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Bispebjerg Hospital (Denmark)
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Address
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Department of Surgery K
Bispebjerg Hospital
University of Copenhagen
Bispebjerg Bakke 23
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City/town
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Copenhagen
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Zip/Postcode
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DK-2400
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Country
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Denmark
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Tel
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+45 35316493
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Fax
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+45 35312981
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Email
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magnus.agren@get2net.dk
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Date applied
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20/09/2004
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Last edited
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25/09/2009
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Date ISRCTN assigned
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29/09/2004
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