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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
|Official Title:||Antimicrobial Coated Sutures in Paediatric Surgery|
- occurrence of surgical site infections [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
|Study Start Date:||September 2010|
|Study Completion Date:||January 2015|
|Primary Completion Date:||January 2015 (Final data collection date for primary outcome measure)|
triclosan coated suture material
Triclosane coated suture material
Other Name: Vicryl plus
Active Comparator: Control
ordinary suture material
Ordinary suture material
Other Name: Vicryl
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).
Please refer to this study by its ClinicalTrials.gov identifier: NCT01220700
|Oulu University Hospital/ Paediatric Surgery|
|Oulu, Finland, 90230|
|Principal Investigator:||Marjo Renko, MD, PhD||University of Oulu, Department of Paediatrics|
|Study Chair:||Terhi Tapiainen, MD, PhD||University of Oulu, Deparment of Paediatrics|
|Study Chair:||Willy Serlo, prof||University of Oulu, Deparment of Peadiatric Surgery|
|Study Director:||Matti Uhari, prof||University of Oulu, Department of Paediatrics|
|Study Chair:||Juha-Jaakko Sinikumpu, MD||University of Oulu, Department of Paediatric Surgery|