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.

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Key information

Conditions

Wound Infections Infections Wound Infection

Age range

4 week–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Oulu University Hospital/ Paediatric Surgery

Oulu, 90230, Finland

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

any general surgery during childhood where melting sutures will be used

Exclusion criteria

wound infection as a cause for surgery

Treatment and study plan

Triclosane

Other

Triclosane coated suture material

Other names: Vicryl plus

Control

Other

Ordinary suture material

Other names: Vicryl

Primary outcomes

occurrence of surgical site infections

Time frame: 30 days

Sponsors and collaborators

Lead sponsor

University of Oulu

Other

Registry information

Important dates

Study start: 2010
Primary completion: 2015
Study completion: 2015
First posted: Oct 14, 2010
Registry last updated: Feb 6, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed