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Antimicrobial Coated Sutures in Paediatric Surgery

Sponsor
University of Oulu (Other)
Overall Status
Completed
CT.gov ID
NCT01220700
Collaborator
(none)
1,635
Enrollment
1
Location
2
Arms
52
Duration (Months)
31.4
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Triclosane
  • Other: Control
 N/A

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).

Study Design

Study Type:
Interventional
Actual Enrollment :
1635 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Prevention
Official Title:
Antimicrobial Coated Sutures in Paediatric Surgery
Study Start Date :
Sep 1, 2010
Actual Primary Completion Date :
Jan 1, 2015
Actual Study Completion Date :
Jan 1, 2015

Arms and Interventions

Arm Intervention/Treatment
Experimental: Triclosane

triclosan coated suture material

Other: Triclosane
Triclosane coated suture material
Other Names:
  • Vicryl plus

    		•
    Active Comparator: Control

    ordinary suture material

    Other: Control
    Ordinary suture material
    Other Names:
  • Vicryl

    		•

    Outcome Measures

    Primary Outcome Measures

    1. occurrence of surgical site infections [30 days]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    4 Weeks to 18 Years
    Sexes Eligible for Study:
    All
    Accepts 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Oulu University Hospital/ Paediatric Surgery Oulu Finland 90230

    Sponsors and Collaborators

    • University of Oulu

    Investigators

    • Principal Investigator: Marjo Renko, MD, PhD, University of Oulu, Department of Paediatrics
    • Study Chair: Terhi Tapiainen, MD, PhD, University of Oulu, Deparment of Paediatrics
    • Study Chair: Willy Serlo, prof, University of Oulu, Deparment of Peadiatric Surgery
    • Study Director: Matti Uhari, prof, University of Oulu, Department of Paediatrics
    • Study Chair: Juha-Jaakko Sinikumpu, MD, University of Oulu, Department of Paediatric Surgery

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Marjo Renko, docent, University of Oulu
    ClinicalTrials.gov Identifier:
    NCT01220700
    Other Study ID Numbers:
    • Triclosan
    First Posted:
    Oct 14, 2010
    Last Update Posted:
    Feb 6, 2015
    Last Verified:
    Feb 1, 2015
    Additional relevant MeSH terms:
    Wound Infection

    Study Results

    No Results Posted as of Feb 6, 2015