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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Triclosane | Experimental | triclosan coated suture material |
|
| Control | Active Comparator | ordinary suture material |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Triclosane | Other | Triclosane coated suture material |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| occurrence of surgical site infections | 30 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Marjo Renko, MD, PhD | University of Oulu, Department of Paediatrics | Principal Investigator |
| Terhi Tapiainen, MD, PhD | University of Oulu, Deparment of Paediatrics | Study Chair |
| Willy Serlo, prof | University of Oulu, Deparment of Peadiatric Surgery | Study Chair |
| Matti Uhari, prof | University of Oulu, Department of Paediatrics | Study Director |
| Juha-Jaakko Sinikumpu, MD | University of Oulu, Department of Paediatric Surgery | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Oulu University Hospital/ Paediatric Surgery | Oulu | 90230 | Finland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27658562 | Derived | Renko M, Paalanne N, Tapiainen T, Hinkkainen M, Pokka T, Kinnula S, Sinikumpu JJ, Uhari M, Serlo W. Triclosan-containing sutures versus ordinary sutures for reducing surgical site infections in children: a double-blind, randomised controlled trial. Lancet Infect Dis. 2017 Jan;17(1):50-57. doi: 10.1016/S1473-3099(16)30373-5. Epub 2016 Sep 19. |
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| ID | Term |
|---|---|
| D014946 | Wound Infection |
| ID | Term |
|---|---|
| D007239 | Infections |
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| ID | Term |
|---|---|
| D011098 | Polyglactin 910 |
| ID | Term |
|---|---|
| D011091 | Polyesters |
| D011108 | Polymers |
| D046911 | Macromolecular Substances |
| D001697 | Biomedical and Dental Materials |
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| Control | Other | Ordinary suture material |
|
|
| D008420 |
| Manufactured Materials |
| D013676 | Technology, Industry, and Agriculture |