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

NCT ID: NCT01457859

Last Updated: 2011-10-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

410 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-10-31

Study Completion Date

2013-10-31

Brief Summary

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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.

Detailed Description

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Conditions

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Complication of Coronary Artery Bypass Graft Surgical Wound Infection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Conventional sutures

Group Type ACTIVE_COMPARATOR

Conventional non-coated surgical sutures

Intervention Type OTHER

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

Antiseptic sutures

Group Type EXPERIMENTAL

Triclosan

Intervention Type DRUG

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

Interventions

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Triclosan

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

Intervention Type DRUG

Conventional non-coated surgical sutures

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

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Rambam Health Care Campus

OTHER

Sponsor Role lead

Responsible Party

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Dr. Shani Liran

Cardiac surgery resident

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Liran Shani, MD

Role: PRINCIPAL_INVESTIGATOR

Rambam Health Care Campus

Locations

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Rambam Health Care Campus, Depatment of cardiac surgery

Haifa, , Israel

Site Status

Countries

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Israel

Central Contacts

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Liran Shani, MD

Role: CONTACT

[email protected]

Facility Contacts

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Liran Shani, MD

Role: primary

[email protected]

Other Identifiers

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RMB-0228.CTIL

Identifier Type: -

Identifier Source: org_study_id