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Antimicrobial Coated Sutures in Paediatric Surgery

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ClinicalTrials.gov Identifier: NCT01220700
Recruitment Status : Completed
First Posted : October 14, 2010
Last Update Posted : February 6, 2015
Sponsor:
Information provided by (Responsible Party):

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
Wound Infections Other: Triclosane Other: Control

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  (Clinical Trial)
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 : September 2010
Primary Completion Date : January 2015
Study Completion Date : January 2015

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Triclosane
triclosan coated suture material
Other: Triclosane
Triclosane coated suture material
Other Name: Vicryl plus
Active Comparator: Control
ordinary suture material
Other: Control
Ordinary suture material
Other Name: Vicryl


Outcome Measures

Primary Outcome Measures :
  1. occurrence of surgical site infections [ Time Frame: 30 days ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01220700


Locations
Finland
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
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Marjo Renko, docent, University of Oulu
ClinicalTrials.gov Identifier: NCT01220700     History of Changes
Other Study ID Numbers: Triclosan
First Posted: October 14, 2010    Key Record Dates
Last Update Posted: February 6, 2015
Last Verified: February 2015

Additional relevant MeSH terms:
Wound Infection
Infection
Anti-Infective Agents
Anti-Bacterial Agents