Complication of Coronary Artery Bypass GraftPhase 4NCT01457859
Effectiveness of Triclosan Coated Sutures in Preventing Leg Wound Infection After Coronary Artery Bypass Surgery
A Phase 4 study testing Triclosan and Conventional non-coated surgical sutures in people with Complication of Coronary Artery Bypass Graft and Surgical Wound Infection, run by Rambam Health Care Campus at 1 site in Israel.
Trial summary
The purpose of this study is to assess whether triclosan-coated sutures reduces wound infections compared to regular non-coated sutures, after saphenous vein harvesting in CABG patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Complication of Coronary Artery Bypass Graft, Surgical Wound Infection
- What is being tested?
- Triclosan and Conventional non-coated surgical sutures
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 410 participants
- Where
- 1 siteIsrael
- Study dates
- Oct 2011to Oct 2013
- Phase
- Phase 4
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years of age or older with written informed consent
- Male and female subjects
- Subjects scheduled for an elective and urgent CABG surgery that includes saphenous vein harvesting.
Who cannot join
- Known allergy or intolerance to triclosan
- Different surgical prophylactic antibiotic regimen than common in the department.
- Continuous preoperative and predicted postoperative antibiotic treatment.
Trial locations and contacts
1 site in 1 country.
Liran Shani, MD contact
Israel1 site
Rambam Health Care Campus, Depatment of cardiac surgery
Haifa, 31096
Liran Shani, MD, l_shani@rambam.health.gov.il
Liran Shani, MD
About this study
Official title: Effectiveness of Triclosan Coated VICRYL\MONOCRYL Sutures in Preventing Leg Wound Infection Compared to POLYSORB\ BIOSYN Sutures in Patients After Coronary Bypass Surgery- a Randomized Controlled Trial
The purpose of this study is to assess whether triclosan-coated sutures reduces wound infections compared to regular non-coated sutures, after saphenous vein harvesting in CABG patients.
- Being tested
- Triclosan, Conventional non-coated surgical sutures
- 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.
TriclosanDrug
Triclosan coated surgical sewing threads (VICRYL+ and MONOCRYL+) applied for leg wound closure after CABG
Conventional non-coated surgical suturesOther
Conventional non-coated surgical sewing threads (POLYSORB and BIOSYN) will be applied after CABG for leg wound closure
| Study group | Role | What they receive |
|---|---|---|
| Conventional sutures | Active comparator | Not described Receives: Other: Conventional non-coated surgical sutures |
| Antiseptic sutures | Experimental | Not described Receives: Drug: Triclosan |
What is being measured
The primary outcome is the main question the study is designed to answer.
leg wound infection
Proportion of subjects with leg wound infection in research versus control group within 45 days of surgery according to CDC SSI criteria
Measured: Up to 45 days postsurgery
Secondary outcomes (3)
Antibiotics administration
Amount of administered antibiotic for leg wound infection after surgery
Measured: Up to 45 days postsurgery
Hospital Length of stay
Measured: Average of 7 days postsurgery
Incidence of hospital re-admission due to leg wound infection
Measured: Within 45 days postsurgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2011 (estimated)
- Study startOct 2011
- Primary completionOct 2013 (estimated)
- Study completionOct 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Complication of Coronary Artery Bypass GraftStudies 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 410 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rambam Health Care Campus
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Shani Liran, Rambam Health Care Campus
- Investigators
- Liran Shani, MD, Principal investigator, Rambam Health Care Campus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01457859
- Sponsor's protocol ID
- RMB-0228.CTIL
- Status last verified
- Oct 2011
- First submitted
- 16 Oct 2011
- Last updated
- 24 Oct 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Triclosan Coated VICRYL\MONOCRYL Sutures in Preventing Leg Wound Infection Compared to POLYSORB\ BIOSYN Sutures in Patients After Coronary Bypass Surgery- a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01457859
- Acronym / sponsor ID
- RMB-0228.CTIL
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 410 participants (estimated)
- Lead sponsor
- Rambam Health Care CampusUniversity, hospital or other
- Study start
- Oct 2011
- Primary completion
- Oct 2013 (estimated)
- Study completion
- Oct 2013 (estimated)
- First posted
- 24 Oct 2011 (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 assess whether triclosan-coated sutures reduces wound infections compared to regular non-coated sutures, after saphenous vein harvesting in CABG patients.
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 |
|---|---|---|
| Conventional sutures | Active comparator | Other: Conventional non-coated surgical sutures |
| Antiseptic sutures | Experimental | Drug: Triclosan |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 18 years of age or older with written informed consent
- Male and female subjects
- Subjects scheduled for an elective and urgent CABG surgery that includes saphenous vein harvesting.
Key exclusion criteria (3 listed)
- Known allergy or intolerance to triclosan
- Different surgical prophylactic antibiotic regimen than common in the department.
- Continuous preoperative and predicted postoperative antibiotic treatment.
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 |
|---|---|---|
| TriclosanTriclosan coated surgical sewing threads (VICRYL+ and MONOCRYL+) applied for leg wound closure after CABG | Drug | Antiseptic sutures |
| Conventional non-coated surgical suturesConventional non-coated surgical sewing threads (POLYSORB and BIOSYN) will be applied after CABG for leg wound closure | Other | Conventional sutures |
Primary outcome
leg wound infection
Time frame: Up to 45 days postsurgery
Proportion of subjects with leg wound infection in research versus control group within 45 days of surgery according to CDC SSI criteria
3 secondary outcomes
Antibiotics administration
Time frame: Up to 45 days postsurgery
Hospital Length of stay
Time frame: Average of 7 days postsurgery
Incidence of hospital re-admission due to leg wound infection
Time frame: Within 45 days postsurgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2011.
Related trials for Complication of Coronary Artery Bypass Graft
Not yet recruitingPhase 4
Roxadustat and Myocardial Injury After Off-Pump Coronary Artery Bypass Surgery
Coronary Artery Disease, Coronary Artery Bypass Grafting
Enrolling by invitation
Feasibility of Physical Prehabilitation for High-Risk Patients Undergoing Cardiac Surgery Via Sternotomy
Prehabilitation, Cardiac Surgery
Not yet recruiting
Bilateral Pecto-Intercostal Fascial Plane Block for Prevention of Chronic Poststernotomy Pain After CABG
Chronic Poststernotomy Pain
Not yet recruiting
BrainProtect-guided, Real-time Cerebral Autoregulation Monitoring and Protection of Brain During Cardiac Surgery With Cardiopulmonary Bypass Requiring Heart-lung Machine
Cerebral Autoregulation Impairment, Postoperative Cognitive Dysfunction
Active, not recruiting
Early Outcomes of Spontaneous vs. Negative-pressure Drainage After Coronary Artery Bypass Grafting
Drainage, Complications Due to Coronary Artery Bypass Graft
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.
Liran Shani, MD contact
Liran Shani, MD principal investigator
Rambam Health Care Campus
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Triclosan and Conventional non-coated surgical sutures in people with Complication of Coronary Artery Bypass Graft and Surgical Wound Infection, run by Rambam Health Care Campus at 1 site in Israel.
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 3 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 24 Oct 2011. 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 Israel. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Liran Shani, MD (l_shani@rambam.health.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
leg wound infection (time frame: Up to 45 days postsurgery). 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 24 Oct 2011.