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Effectiveness of Triclosan Coated Sutures in Preventing Leg Wound Infection After Coronary Artery Bypass Surgery

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified October 2011 by Dr. Shani Liran, Rambam Health Care Campus.
Recruitment status was:  Not yet recruiting
Information provided by (Responsible Party):
Dr. Shani Liran, Rambam Health Care Campus Identifier:
First received: October 16, 2011
Last updated: October 21, 2011
Last verified: October 2011
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.

Condition Intervention Phase
Complication of Coronary Artery Bypass Graft Surgical Wound Infection Drug: Triclosan Other: Conventional non-coated surgical sutures Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
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

Resource links provided by NLM:

Further study details as provided by Dr. Shani Liran, Rambam Health Care Campus:

Primary Outcome Measures:
  • 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

Secondary Outcome Measures:
  • Antibiotics administration [ Time Frame: Up to 45 days postsurgery ]
    Amount of administered antibiotic for leg wound infection after surgery

  • 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 ]

Estimated Enrollment: 410
Study Start Date: October 2011
Estimated Study Completion Date: October 2013
Estimated Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Conventional sutures Other: Conventional non-coated surgical sutures
Conventional non-coated surgical sewing threads (POLYSORB and BIOSYN) will be applied after CABG for leg wound closure
Experimental: Antiseptic sutures Drug: Triclosan
Triclosan coated surgical sewing threads (VICRYL+ and MONOCRYL+) applied for leg wound closure after CABG


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • Known allergy or intolerance to triclosan
  • Different surgical prophylactic antibiotic regimen than common in the department.
  • Continuous preoperative and predicted postoperative antibiotic treatment.
  Contacts and Locations
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Please refer to this study by its identifier: NCT01457859

Contact: Liran Shani, MD

Rambam Health Care Campus, Depatment of cardiac surgery Not yet recruiting
Haifa, Israel, 31096
Contact: Liran Shani, MD   
Principal Investigator: Liran Shani, MD         
Sponsors and Collaborators
Rambam Health Care Campus
Principal Investigator: Liran Shani, MD Rambam Health Care Campus
  More Information

Responsible Party: Dr. Shani Liran, Cardiac surgery resident, Rambam Health Care Campus Identifier: NCT01457859     History of Changes
Other Study ID Numbers: RMB-0228.CTIL
Study First Received: October 16, 2011
Last Updated: October 21, 2011

Additional relevant MeSH terms:
Communicable Diseases
Wounds and Injuries
Wound Infection
Surgical Wound Infection
Postoperative Complications
Pathologic Processes
Anti-Infective Agents, Local
Anti-Infective Agents
Fatty Acid Synthesis Inhibitors
Hypolipidemic Agents
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents processed this record on September 21, 2017