Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
1635 participants
INTERVENTIONAL
2010-09-30
2015-01-31
Brief Summary
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1500 children (age form 4 weeks to 18 years) coming for general pediatric surgery to the Oulu University Hospital are randomised to have sutures coated with triclosan (Vicryl Plus, Monocryl Plus) or ordinary sutures. The occurrence of SSIs is monitored by email questionnaires to the parents on days 10 and 30. The diagnosis of SSIs are made along CDC criteria.
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Detailed Description
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We have decided to prolong recruiting so that we would gather the calculated sample size of 1500 of patient with study suture material. This will take 12-18 months (probably till autumn 2015).
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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Triclosane
triclosan coated suture material
Triclosane
Triclosane coated suture material
Control
ordinary suture material
Control
Ordinary suture material
Interventions
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Triclosane
Triclosane coated suture material
Control
Ordinary suture material
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
4 Weeks
18 Years
ALL
No
Sponsors
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University of Oulu
OTHER
Responsible Party
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Marjo Renko
docent
Principal Investigators
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Marjo Renko, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Oulu, Department of Paediatrics
Terhi Tapiainen, MD, PhD
Role: STUDY_CHAIR
University of Oulu, Deparment of Paediatrics
Willy Serlo, prof
Role: STUDY_CHAIR
University of Oulu, Deparment of Peadiatric Surgery
Matti Uhari, prof
Role: STUDY_DIRECTOR
University of Oulu, Department of Paediatrics
Juha-Jaakko Sinikumpu, MD
Role: STUDY_CHAIR
University of Oulu, Department of Paediatric Surgery
Locations
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Oulu University Hospital/ Paediatric Surgery
Oulu, , Finland
Countries
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References
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Renko M, Paalanne N, Tapiainen T, Hinkkainen M, Pokka T, Kinnula S, Sinikumpu JJ, Uhari M, Serlo W. Triclosan-containing sutures versus ordinary sutures for reducing surgical site infections in children: a double-blind, randomised controlled trial. Lancet Infect Dis. 2017 Jan;17(1):50-57. doi: 10.1016/S1473-3099(16)30373-5. Epub 2016 Sep 19.
Other Identifiers
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Triclosan
Identifier Type: -
Identifier Source: org_study_id
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