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Antimicrobial Coated Sutures in Paediatric Surgery

Antimicrobial Coated Sutures in Paediatric Surgery

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01220700
Enrollment
1635
Registered
2010-10-14
Start date
2010-09-30
Completion date
2015-01-31
Last updated
2015-02-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Wound Infections

Brief 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).

Interventions

OTHERTriclosane

Triclosane coated suture material

OTHERControl

Ordinary suture material

Sponsors

University of Oulu
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
4 Weeks to 18 Years
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

* wound infection as a cause for surgery

Design outcomes

Primary

MeasureTime frame
occurrence of surgical site infections30 days

Countries

Finland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 12, 2026