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Antimicrobial Coated Sutures in Paediatric Surgery

NCT01220700 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1635

Last updated 2015-02-06

No results posted yet for this study

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.

Conditions

  • Wound Infections

Interventions

OTHER

Triclosane

Triclosane coated suture material

OTHER

Control

Ordinary suture material

Sponsors & Collaborators

  • University of Oulu

    lead OTHER

Principal Investigators

  • Marjo Renko, MD, PhD · University of Oulu, Department of Paediatrics

  • Terhi Tapiainen, MD, PhD · University of Oulu, Deparment of Paediatrics

  • Willy Serlo, prof · University of Oulu, Deparment of Peadiatric Surgery

  • Matti Uhari, prof · University of Oulu, Department of Paediatrics

  • Juha-Jaakko Sinikumpu, MD · University of Oulu, Department of Paediatric Surgery

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
4 Weeks
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-09-30
Primary Completion
2015-01-31
Completion
2015-01-31

Countries

  • Finland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01220700 on ClinicalTrials.gov