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

This study is not yet open for participant recruitment.
Verified October 2011 by Rambam Health Care Campus
Sponsor:
Information provided by (Responsible Party):
Dr. Shani Liran, Rambam Health Care Campus
ClinicalTrials.gov Identifier:
NCT01457859
First received: October 16, 2011
Last updated: October 21, 2011
Last verified: October 2011
History of Changes
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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:

U.S. FDA Resources

Further study details as provided by Rambam Health Care Campus:

Primary Outcome Measures:
  • leg wound infection [ Time Frame: Up to 45 days postsurgery ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Amount of administered antibiotic for leg wound infection after surgery

  • Hospital Length of stay [ Time Frame: Average of 7 days postsurgery ] [ Designated as safety issue: No ]
  • Incidence of hospital re-admission due to leg wound infection [ Time Frame: Within 45 days postsurgery ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: October 16, 2011
Last Updated: October 21, 2011
Health Authority: Israel: Ministry of Health

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

ClinicalTrials.gov processed this record on June 17, 2013