NCT01220700

Antimicrobial Coated Sutures in Paediatric Surgery

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,635 (actual)
• Sponsor: University of Oulu · Academic / Other
• Sex: All
• Age: 4 Weeks – 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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).

Conditions

• Wound Infections

Interventions

Type	Name	Description
OTHER	Triclosane	Triclosane coated suture material
OTHER	Control	Ordinary suture material

Timeline

• Start date: 2010-09-01
• Primary completion: 2015-01-01
• Completion: 2015-01-01
• First posted: 2010-10-14
• Last updated: 2015-02-06

Locations

1 site across 1 country: Finland