Surgical Wound InfectionNCT01101789
Triclosan Coated Suture Wound Closure for Peripheral Vascular Surgery: a Prospective Multicenter Study
A study testing triclosan coated suture for surgical wound closure and regular sutures for surgical wound closure in people with Surgical Wound Infection, run by North Karelia Central Hospital at 1 site in Finland.
Trial summary
This is a prospective randomized multicenter study which purpose is to determine whether triclosan-coated sutures for wound closure after lower limb vascular surgery would reduce the incidence of surgical wound infections. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Surgical Wound Infection
- What is being tested?
- triclosan coated suture for surgical wound closure and regular sutures for surgical wound closure
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 276 participants
- Where
- 1 siteFinland
- Study dates
- Apr 2010to Jan 2011
- 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 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patient undergoing peripheral vascular surgery procedure
Who cannot join
- patients refusal
Trial locations and contacts
1 site in 1 country.
About this study
This is a prospective randomized multicenter study which purpose is to determine whether triclosan-coated sutures for wound closure after lower limb vascular surgery would reduce the incidence of surgical wound infections.
- Conditions
- Surgical Wound Infection
- Being tested
- triclosan coated suture for surgical wound closure, regular sutures for surgical wound closure
- Keywords
- surgical wound infection, triclosan-coated suture
- Medical subject headings
- Surgical Wound Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
triclosan coated suture for surgical wound closureProcedure or surgery
triclosan coated suture for surgical wound closure
regular sutures for surgical wound closureProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| triclosan | Active comparator | triclosan-coated sutures Receives: Procedure: triclosan coated suture for surgical wound closure |
| control | Placebo comparator | sutures without triclosan-coating Receives: Procedure: regular sutures for surgical wound closure |
What is being measured
The primary outcome is the main question the study is designed to answer.
surgical wound infection
Measured: one month after surgical procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2010 (estimated)
- Study startApr 2010
- Primary completionJan 2011
- Study completionJan 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Surgical Wound InfectionStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 276 participants (actual)
Sponsor and investigators
- Lead sponsor
- North Karelia Central Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sanna Kouhia, North Karelia Central Hospital
- Investigators
- Johanna Turtiainen, MD, Study director, North Karelia Central HospitalKimmo Makinen, Principal investigator, Kuopio University HospitalMaarit Venermo, Principal investigator, Helsinki University Central HospitalEija Saimanen, Principal investigator, South Carelia Central HospitalIlkka Uurto, Study director, Tampere University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01101789
- Sponsor's protocol ID
- NKCH-surg-006
- Status last verified
- Oct 2015
- First submitted
- 8 Apr 2010
- Last updated
- 14 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Triclosan Coated Suture Wound Closure for Peripheral Vascular Surgery: a Prospective Multicenter Study
- ClinicalTrials.gov ID
- NCT01101789
- Acronym / sponsor ID
- NKCH-surg-006
- Conditions
- Surgical Wound Infection
- Keywords
- surgical wound infection, triclosan-coated suture
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 276 participants (actual)
- Lead sponsor
- North Karelia Central HospitalUniversity, hospital or other
- Study start
- Apr 2010
- Primary completion
- Jan 2011 (actual)
- Study completion
- Jan 2011 (actual)
- First posted
- 12 Apr 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.
This is a prospective randomized multicenter study which purpose is to determine whether triclosan-coated sutures for wound closure after lower limb vascular surgery would reduce the incidence of surgical wound infections.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| triclosan | Active comparator | Procedure: triclosan coated suture for surgical wound closuretriclosan-coated sutures |
| control | Placebo comparator | Procedure: regular sutures for surgical wound closuresutures without triclosan-coating |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patient undergoing peripheral vascular surgery procedure
Key exclusion criteria (1 listed)
- patients refusal
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 |
|---|---|---|
| triclosan coated suture for surgical wound closuretriclosan coated suture for surgical wound closure | Procedure or surgery | triclosan |
| regular sutures for surgical wound closure | Procedure or surgery | control |
Primary outcome
surgical wound infection
Time frame: one month after surgical procedure
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 14 Oct 2015.
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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.
Johanna Turtiainen, MD study director
North Karelia Central Hospital
Kimmo Makinen principal investigator
Kuopio University Hospital
Maarit Venermo principal investigator
Helsinki University Central Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing triclosan coated suture for surgical wound closure and regular sutures for surgical wound closure in people with Surgical Wound Infection, run by North Karelia Central Hospital 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 14 Oct 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. Some participants in this study may receive a placebo. 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?
surgical wound infection (time frame: one month after surgical procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Oct 2015.