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

Rambam Health Care Campus410 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Enrollment

410

Conditions

Complication of Coronary Artery Bypass Graft Surgical Wound Infection

Interventions

TriclosanDRUG

Triclosan coated surgical sewing threads (VICRYL+ and MONOCRYL+) applied for leg wound closure after CABG

Conventional non-coated surgical suturesOTHER

Conventional non-coated surgical sewing threads (POLYSORB and BIOSYN) will be applied after CABG for leg wound closure

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Rambam Health Care Campus, Depatment of cardiac surgery

Haifa, Israel

Outcomes

Primary Outcomes

leg wound infection

Proportion of subjects with leg wound infection in research versus control group within 45 days of surgery according to CDC SSI criteria

Time frame: Up to 45 days postsurgery

Secondary Outcomes

Antibiotics administration

Amount of administered antibiotic for leg wound infection after surgery

Time frame: Up to 45 days postsurgery

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

Central Contacts

Liran Shani, MD

CONTACT

l_shani@rambam.health.gov.il

Data from ClinicalTrials.gov

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