Surgical Site InfectionPhase 3NCT02018289
Effect of Triclosan-coated Suture on Superficial SSI
A Phase 3 study testing Triclosan coated suture and No triclosan in people with Surgical Site Infection, run by Hospital General Universitario Elche at 1 site in Spain.
Trial summary
The abdominal closure with triclosan coated suture will reduce superficial surgical site infection. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Surgical Site Infection
- What is being tested?
- Triclosan coated suture and No triclosan
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 106 participants
- Where
- 1 siteSpain
- Study dates
- Oct 2007to Dec 2013
- Phase
- Phase 3
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Fecal peritonitis
Who cannot join
- Perioperative mortality
Trial locations and contacts
1 site in 1 country.
About this study
The abdominal closure with triclosan coated suture will reduce superficial surgical site infection.
- Conditions
- Surgical Site Infection
- Being tested
- Triclosan coated suture, No triclosan
- Keywords
- Triclosan coated suture, Surgical site infection, Fecal peritonitis, Superficial, incisional
- Medical subject headings
- Surgical Wound Infection, Surgical Wound
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Triclosan coated sutureProcedure or surgery
Suture of the abdominal wall with triclosan coated suture
No triclosanProcedure or surgery
Suture of the abdominal wall with suture without triclosan coat
| Study group | Role | What they receive |
|---|---|---|
| Triclosan | Experimental | Suture of the abdominal wall with triclosan coated suture Receives: Procedure: Triclosan coated suture |
| No triclosan | Sham comparator | Suture of the abdominal wall with the same suture, but without triclosan Receives: Procedure: No triclosan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Superficial surgical site infection (SSI)
SSI will be evaluated in the postoperative course and up to 60 days after surgery
Measured: 60 postoperative days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2013 (estimated)
- Study startOct 2007
- Primary completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Surgical Site 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 106 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital General Universitario Elche
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jaime Ruiz-Tovar, MD, PhD, Hospital General Universitario Elche
- Investigators
- Jaime Ruiz-Tovar, MD, PhD, Principal investigator, Hospital General Universitario de Elche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02018289
- Sponsor's protocol ID
- 2013-0010
- Status last verified
- Dec 2013
- First submitted
- 17 Dec 2013
- Last updated
- 23 Dec 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Triclosan-coated Suture on Superficial SSI
- ClinicalTrials.gov ID
- NCT02018289
- Acronym / sponsor ID
- 2013-0010
- Conditions
- Surgical Site Infection
- Keywords
- Triclosan coated suture, Surgical site infection, Fecal peritonitis, Superficial, incisional
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 106 participants (actual)
- Lead sponsor
- Hospital General Universitario ElcheUniversity, hospital or other
- Study start
- Oct 2007
- Primary completion
- Dec 2013 (actual)
- First posted
- 23 Dec 2013 (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 abdominal closure with triclosan coated suture will reduce superficial surgical site infection.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Triclosan | Experimental | Procedure: Triclosan coated sutureSuture of the abdominal wall with triclosan coated suture |
| No triclosan | Sham comparator | Procedure: No triclosanSuture of the abdominal wall with the same suture, but without triclosan |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Fecal peritonitis
Key exclusion criteria (1 listed)
- Perioperative mortality
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 sutureSuture of the abdominal wall with triclosan coated suture | Procedure or surgery | Triclosan |
| No triclosanSuture of the abdominal wall with suture without triclosan coat | Procedure or surgery | No triclosan |
Primary outcome
Superficial surgical site infection (SSI)
Time frame: 60 postoperative days
SSI will be evaluated in the postoperative course and up to 60 days after surgery
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 23 Dec 2013.
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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.
Jaime Ruiz-Tovar, MD, PhD principal investigator
Hospital General Universitario de Elche
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Triclosan coated suture and No triclosan in people with Surgical Site Infection, run by Hospital General Universitario Elche at 1 site in Spain.
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 23 Dec 2013. 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 Spain. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Superficial surgical site infection (SSI) (time frame: 60 postoperative days). 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 23 Dec 2013.