Antimicrobial Coated Sutures in Paediatric Surgery

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by University of Oulu
Sponsor:
Information provided by (Responsible Party):
Marjo Renko, University of Oulu
ClinicalTrials.gov Identifier:
NCT01220700
First received: October 12, 2010
Last updated: May 8, 2014
Last verified: May 2014

October 12, 2010
May 8, 2014
October 2010
December 2015   (final data collection date for primary outcome measure)
occurrence of surgical site infections [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
occurrence of wound infection [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT01220700 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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Antimicrobial Coated Sutures in Paediatric Surgery
Antimicrobial Coated Sutures in Paediatric Surgery

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.

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).

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Wound Infections
  • Other: Triclosane
    Triclosane coated suture material
    Other Name: Vicryl plus
  • Other: Control
    Ordinary suture material
    Other Name: Vicryl
  • Experimental: Triclosane
    triclosan coated suture material
    Intervention: Other: Triclosane
  • Active Comparator: Control
    ordinary suture material
    Intervention: Other: Control
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
1800
December 2015
December 2015   (final data collection date for primary outcome measure)

Inclusion Criteria:

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

Exclusion Criteria:

  • wound infection as a cause for surgery
Both
up to 18 Years
No
Contact: Marjo Renko, MD +35883155132 marjo.renko@oulu.fi
Contact: Leena Okkonen, study nurse +35883155126 leena.okkonen@ppshp.fi
Finland
 
NCT01220700
Triclosan
No
Marjo Renko, University of Oulu
University of Oulu
Not Provided
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
University of Oulu
May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP