Wound Infections Clinical Trial
Official title:
Antimicrobial Coated Sutures in Paediatric Surgery
The purpose of this study is to determine if suture material coated by antimicrobial agent
triclosan would decrease the incidence of surgical site infections (SSIs) in paediatric
surgery compared to ordinary sutures.
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.
We have now (spring 2014) recruited almost 1500 patients to the study. When reviewing the
recruited material, we found out that the study suture material has been used in 83% of the
recruited patients. The reasons for this have been clinical issue during the operation where
melting suture material may not have been needed at all.
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).
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
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