NCT01220700

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,635

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2010

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2010

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

October 12, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 14, 2010

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2015

Completed
Last Updated

February 6, 2015

Status Verified

February 1, 2015

Enrollment Period

4.3 years

First QC Date

October 12, 2010

Last Update Submit

February 5, 2015

Conditions

Wound Infections

Outcome Measures

Primary Outcomes (1)

  • occurrence of surgical site infections

    30 days

Study Arms (2)

Triclosane

EXPERIMENTAL

triclosan coated suture material

Other: Triclosane

Control

ACTIVE COMPARATOR

ordinary suture material

Other: Control

Interventions

TriclosaneOTHER

Triclosane coated suture material

Also known as: Vicryl plus
Triclosane
ControlOTHER

Ordinary suture material

Also known as: Vicryl
Control

Eligibility Criteria

Age4 Weeks - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

  • wound infection as a cause for surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oulu University Hospital/ Paediatric Surgery

Oulu, 90230, Finland

Location

Related Publications (1)

  • Renko M, Paalanne N, Tapiainen T, Hinkkainen M, Pokka T, Kinnula S, Sinikumpu JJ, Uhari M, Serlo W. Triclosan-containing sutures versus ordinary sutures for reducing surgical site infections in children: a double-blind, randomised controlled trial. Lancet Infect Dis. 2017 Jan;17(1):50-57. doi: 10.1016/S1473-3099(16)30373-5. Epub 2016 Sep 19.

    PMID: 27658562DERIVED

MeSH Terms

Conditions

Wound Infection

Interventions

Polyglactin 910

Condition Hierarchy (Ancestors)

Infections

Intervention Hierarchy (Ancestors)

PolyestersPolymersMacromolecular SubstancesBiomedical and Dental MaterialsManufactured MaterialsTechnology, Industry, and Agriculture

Study Officials

  • Marjo Renko, MD, PhD

    University of Oulu, Department of Paediatrics

    PRINCIPAL INVESTIGATOR

  • Terhi Tapiainen, MD, PhD

    University of Oulu, Deparment of Paediatrics

    STUDY CHAIR

  • Willy Serlo, prof

    University of Oulu, Deparment of Peadiatric Surgery

    STUDY CHAIR

  • Matti Uhari, prof

    University of Oulu, Department of Paediatrics

    STUDY DIRECTOR

  • Juha-Jaakko Sinikumpu, MD

    University of Oulu, Department of Paediatric Surgery

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
docent

Study Record Dates

First Submitted

October 12, 2010

First Posted

October 14, 2010

Study Start

September 1, 2010

Primary Completion

January 1, 2015

Study Completion

January 1, 2015

Last Updated

February 6, 2015

Record last verified: 2015-02

Locations

FI(1)