Antimicrobial Coated Sutures in Paediatric Surgery

Wound Infections Clinical Trial

Official title:

Antimicrobial Coated Sutures in Paediatric Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01220700
• Other study ID #: Triclosan
• Status: Completed
• Phase: N/A
• First received: October 12, 2010
• Last updated: February 5, 2015
• Start date: September 2010
• Est. completion date: January 2015

Study information

• Verified date: February 2015
• Source: University of Oulu
• Contact: n/a
• Is FDA regulated: No
• Health authority: Finland: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1635
• Est. completion date: January 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 18 Years

Eligibility

Inclusion Criteria:

• any general surgery during childhood where melting sutures will be used

Exclusion Criteria:

• wound infection as a cause for surgery

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Wound Infection
• Wound Infections

Intervention

Other:
• Triclosane
Triclosane coated suture material
• Control
Ordinary suture material

Locations

Country	Name	City	State
Finland	Oulu University Hospital/ Paediatric Surgery	Oulu

Sponsors (1)

Lead Sponsor	Collaborator
University of Oulu

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	occurrence of surgical site infections		30 days	Yes