Antimicrobial Coated Sutures in Paediatric Surgery

NCT ID: NCT01220700

Last Updated: 2015-02-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

1635 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-09-30

Study Completion Date

2015-01-31

Brief Summary

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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

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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).

Conditions

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Wound Infections

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Triclosane

triclosan coated suture material

Group Type EXPERIMENTAL

Triclosane

Intervention Type OTHER

Triclosane coated suture material

Control

ordinary suture material

Group Type ACTIVE_COMPARATOR

Control

Intervention Type OTHER

Ordinary suture material

Interventions

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Triclosane

Triclosane coated suture material

Intervention Type OTHER

Control

Ordinary suture material

Intervention Type OTHER

Other Intervention Names

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Vicryl plus Vicryl

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* wound infection as a cause for surgery
Minimum Eligible Age

4 Weeks

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Oulu

OTHER

Sponsor Role lead

Responsible Party

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Marjo Renko

docent

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Marjo Renko, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Oulu, Department of Paediatrics

Terhi Tapiainen, MD, PhD

Role: STUDY_CHAIR

University of Oulu, Deparment of Paediatrics

Willy Serlo, prof

Role: STUDY_CHAIR

University of Oulu, Deparment of Peadiatric Surgery

Matti Uhari, prof

Role: STUDY_DIRECTOR

University of Oulu, Department of Paediatrics

Juha-Jaakko Sinikumpu, MD

Role: STUDY_CHAIR

University of Oulu, Department of Paediatric Surgery

Locations

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Oulu University Hospital/ Paediatric Surgery

Oulu, , Finland

Site Status

Countries

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Finland

References

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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.

Reference Type DERIVED
PMID: 27658562 (View on PubMed)

Other Identifiers

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Triclosan

Identifier Type: -

Identifier Source: org_study_id

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