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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
Sponsor:
ClinicalTrials.gov Identifier:
NCT01457859
First Posted: October 24, 2011
Last Update Posted: October 24, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Dr. Shani Liran, Rambam Health Care Campus
  Purpose
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

  Eligibility

Information from the National Library of Medicine

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

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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01457859


Contacts
Contact: Liran Shani, MD l_shani@rambam.health.gov.il

Locations
Israel
Rambam Health Care Campus, Depatment of cardiac surgery Not yet recruiting
Haifa, Israel, 31096
Contact: Liran Shani, MD       l_shani@rambam.health.gov.il   
Principal Investigator: Liran Shani, MD         
Sponsors and Collaborators
Rambam Health Care Campus
Investigators
Principal Investigator: Liran Shani, MD Rambam Health Care Campus
  More Information

Responsible Party: Dr. Shani Liran, Cardiac surgery resident, Rambam Health Care Campus
ClinicalTrials.gov Identifier: NCT01457859     History of Changes
Other Study ID Numbers: RMB-0228.CTIL
First Submitted: October 16, 2011
First Posted: October 24, 2011
Last Update Posted: October 24, 2011
Last Verified: October 2011

Additional relevant MeSH terms:
Infection
Communicable Diseases
Wounds and Injuries
Wound Infection
Surgical Wound
Surgical Wound Infection
Postoperative Complications
Pathologic Processes
Triclosan
Anti-Infective Agents, Local
Anti-Infective Agents
Fatty Acid Synthesis Inhibitors
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents