Wound InfectionsNCT01220700
Antimicrobial Coated Sutures in Paediatric Surgery
A study testing Triclosane in people with Wound Infections, run by University of Oulu at 1 site in Finland.
Trial 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. Read more about this study
- Who is it for?
- Ages 4 weeks to 18 years
- Conditions the study is for
- Wound Infections
- What is being tested?
- Triclosane
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,635 participants
- Where
- 1 siteFinland
- Study dates
- Sep 2010to Jan 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 weeks to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- any general surgery during childhood where melting sutures will be used
Who cannot join
- wound infection as a cause for surgery
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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).
- Conditions
- Wound Infections
- Being tested
- Triclosane, Control
- Medical subject headings
- Wound Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TriclosaneOther
Also called Vicryl plus
Triclosane coated suture material
ControlOther
Also called Vicryl
Ordinary suture material
| Study group | Role | What they receive |
|---|---|---|
| Triclosane | Experimental | triclosan coated suture material Receives: Other: Triclosane |
| Control | Active comparator | ordinary suture material Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
occurrence of surgical site infections
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2010 (estimated)
- Study startSep 2010
- Primary completionJan 2015
- Study completionJan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Wound InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 1,635 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oulu
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marjo Renko, University of Oulu
- Investigators
- Marjo Renko, MD, PhD, Principal investigator, University of Oulu, Department of PaediatricsTerhi Tapiainen, MD, PhD, Study chair, University of Oulu, Deparment of PaediatricsWilly Serlo, prof, Study chair, University of Oulu, Deparment of Peadiatric SurgeryMatti Uhari, prof, Study director, University of Oulu, Department of PaediatricsJuha-Jaakko Sinikumpu, MD, Study chair, University of Oulu, Department of Paediatric Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01220700
- Sponsor's protocol ID
- Triclosan
- Status last verified
- Feb 2015
- First submitted
- 12 Oct 2010
- Last updated
- 6 Feb 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 27658562
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Antimicrobial Coated Sutures in Paediatric Surgery
- ClinicalTrials.gov ID
- NCT01220700
- Acronym / sponsor ID
- Triclosan
- Conditions
- Wound Infections
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,635 participants (actual)
- Lead sponsor
- University of OuluUniversity, hospital or other
- Study start
- Sep 2010
- Primary completion
- Jan 2015 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 14 Oct 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Triclosane | Experimental | Other: Triclosanetriclosan coated suture material |
| Control | Active comparator | Other: Controlordinary suture material |
Who may qualify
- Ages
- 4 weeks to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- any general surgery during childhood where melting sutures will be used
Key exclusion criteria (1 listed)
- wound infection as a cause for surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TriclosaneAlso: Vicryl plusTriclosane coated suture material | Other | Triclosane |
| ControlAlso: VicrylOrdinary suture material | Other | Control |
Primary outcome
occurrence of surgical site infections
Time frame: 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2015.
- Derived from this study: PubMed 27658562Renko 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marjo Renko, MD, PhD principal investigator
University of Oulu, Department of Paediatrics
Terhi Tapiainen, MD, PhD study chair
University of Oulu, Deparment of Paediatrics
Willy Serlo, prof study chair
University of Oulu, Deparment of Peadiatric Surgery
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Triclosane in people with Wound Infections, run by University of Oulu at 1 site in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
occurrence of surgical site infections (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01220700, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2015.