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

R

Rambam Health Care Campus

Status and phase

Unknown
Phase 4

Conditions

Complication of Coronary Artery Bypass Graft
Surgical Wound Infection

Treatments

Drug: Triclosan
Other: Conventional non-coated surgical sutures

Study type

Interventional

Funder types

Other

Identifiers

NCT01457859
RMB-0228.CTIL

Details and patient eligibility

About

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.

Enrollment

410 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

410 participants in 2 patient groups

Conventional sutures
Active Comparator group
Treatment:
Other: Conventional non-coated surgical sutures
Antiseptic sutures
Experimental group
Treatment:
Drug: Triclosan

Trial contacts and locations

1

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Central trial contact

Liran Shani, MD

Data sourced from clinicaltrials.gov

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