Antimicrobial Coated Sutures in Paediatric Surgery
This study is currently recruiting participants.
Verified January 2013 by University of Oulu
Sponsor:
University of Oulu
Information provided by (Responsible Party):
Marjo Renko, University of Oulu
ClinicalTrials.gov Identifier:
NCT01220700
First received: October 12, 2010
Last updated: January 15, 2013
Last verified: January 2013
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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 |
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: | 1500 |
| Study Start Date: | October 2010 |
| Estimated Study Completion Date: | December 2013 |
| Estimated Primary Completion Date: | December 2013 (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
|
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
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: | January 15, 2013 |
| 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 June 17, 2013