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

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

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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