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Antimicrobial Coated Sutures in Paediatric Surgery

Primary Purpose

Wound Infections

Status
Completed
Phase
Not Applicable
Locations
Finland
Study Type
Interventional
Intervention
Triclosane
Control
Sponsored by
University of Oulu
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Wound Infections

Eligibility Criteria

4 Weeks - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • wound infection as a cause for surgery

Sites / Locations

  • Oulu University Hospital/ Paediatric Surgery

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Triclosane

Control

Arm Description

triclosan coated suture material

ordinary suture material

Outcomes

Primary Outcome Measures

occurrence of surgical site infections

Secondary Outcome Measures

Full Information

First Posted
October 12, 2010
Last Updated
February 5, 2015
Sponsor
University of Oulu
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1. Study Identification

Unique Protocol Identification Number
NCT01220700
Brief Title
Antimicrobial Coated Sutures in Paediatric Surgery
Official Title
Antimicrobial Coated Sutures in Paediatric Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
February 2015
Overall Recruitment Status
Completed
Study Start Date
September 2010 (undefined)
Primary Completion Date
January 2015 (Actual)
Study Completion Date
January 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Oulu

4. Oversight

Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Wound Infections

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
1635 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Triclosane
Arm Type
Experimental
Arm Description
triclosan coated suture material
Arm Title
Control
Arm Type
Active Comparator
Arm Description
ordinary suture material
Intervention Type
Other
Intervention Name(s)
Triclosane
Other Intervention Name(s)
Vicryl plus
Intervention Description
Triclosane coated suture material
Intervention Type
Other
Intervention Name(s)
Control
Other Intervention Name(s)
Vicryl
Intervention Description
Ordinary suture material
Primary Outcome Measure Information:
Title
occurrence of surgical site infections
Time Frame
30 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
4 Weeks
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: any general surgery during childhood where melting sutures will be used Exclusion Criteria: wound infection as a cause for surgery
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marjo Renko, MD, PhD
Organizational Affiliation
University of Oulu, Department of Paediatrics
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Terhi Tapiainen, MD, PhD
Organizational Affiliation
University of Oulu, Deparment of Paediatrics
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Willy Serlo, prof
Organizational Affiliation
University of Oulu, Deparment of Peadiatric Surgery
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Matti Uhari, prof
Organizational Affiliation
University of Oulu, Department of Paediatrics
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Juha-Jaakko Sinikumpu, MD
Organizational Affiliation
University of Oulu, Department of Paediatric Surgery
Official's Role
Study Chair
Facility Information:
Facility Name
Oulu University Hospital/ Paediatric Surgery
City
Oulu
ZIP/Postal Code
90230
Country
Finland

12. IPD Sharing Statement

Citations:
PubMed Identifier
27658562
Citation
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.
Results Reference
derived

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Antimicrobial Coated Sutures in Paediatric Surgery

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