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

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

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 Overview

• Status: Unknown
• Conditions: Surgical Wound Infection; Complication of Coronary Artery Bypass Graft
• Intervention / Treatment: Other: Conventional non-coated surgical sutures; Drug: Triclosan

• Study Type: Interventional
• Enrollment (Anticipated): 410
• Phase: Phase 4

Contacts and Locations

Study Locations

• Israel
  • Haifa, Israel, 31096
    • Rambam Health Care Campus, Depatment of cardiac surgery

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Up to 45 days postsurgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Antibiotics administration	Amount of administered antibiotic for leg wound infection after surgery	Up to 45 days postsurgery
Hospital Length of stay		Average of 7 days postsurgery
Incidence of hospital re-admission due to leg wound infection		Within 45 days postsurgery

Collaborators and Investigators

• Sponsor: Rambam Health Care Campus

Study record dates

Study Major Dates

• Study Start: October 1, 2011
• Primary Completion (Anticipated): October 1, 2013
• Study Completion (Anticipated): October 1, 2013

Study Registration Dates

• First Submitted: October 16, 2011
• First Submitted That Met QC Criteria: October 21, 2011
• First Posted (Estimate): October 24, 2011

Study Record Updates

• Last Update Posted (Estimate): October 24, 2011
• Last Update Submitted That Met QC Criteria: October 21, 2011
• Last Verified: October 1, 2011

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Disease Attributes; Infections; Communicable Diseases; Wounds and Injuries; Surgical Wound; Surgical Wound Infection; Wound Infection; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents, Local; Anti-Infective Agents; Antimetabolites; Hypolipidemic Agents; Lipid Regulating Agents; Fatty Acid Synthesis Inhibitors; Triclosan
• Other Study ID Numbers: RMB-0228.CTIL