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
  Purpose

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 Intervention
Wound Infections
Other: Triclosane
Other: Control

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Antimicrobial Coated Sutures in Paediatric Surgery

Resource links provided by NLM:


Further study details as provided by University of Oulu:

Primary Outcome Measures:
  • occurrence of surgical site infections [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 1800
Study Start Date: October 2010
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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).

  Eligibility

Ages Eligible for Study:   up to 18 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01220700

Contacts
Contact: Marjo Renko, MD +35883155132 marjo.renko@oulu.fi
Contact: Leena Okkonen, study nurse +35883155126 leena.okkonen@ppshp.fi

Locations
Finland
Oulu University Hospital/ Paediatric Surgery Recruiting
Oulu, Finland, 90230
Contact: Marjo Renko       marjo.renko@oulu.fi   
Principal Investigator: Marjo Renko, MD, PhD         
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

No publications provided

Responsible Party: Marjo Renko, docent, University of Oulu
ClinicalTrials.gov Identifier: NCT01220700     History of Changes
Other Study ID Numbers: Triclosan
Study First Received: October 12, 2010
Last Updated: May 8, 2014
Health Authority: Finland: Ethics Committee

Additional relevant MeSH terms:
Wound Infection
Infection
Wounds and Injuries
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 19, 2014