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

Phase 4

• Conditions: Complication of Coronary Artery Bypass Graft; Surgical Wound Infection
• Interventions: Other: Conventional non-coated surgical sutures; Drug: Triclosan

• Registration Number: NCT01457859
• Lead Sponsor: Rambam Health Care Campus

Brief Summary

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

Not available

Study Timeline

• Status Verified: 2011-10
• Study Start: 2011-10
• Study First Submitted: 2011-10-16
• Study First Submitted QC: 2011-10-21
• Last Update Submitted: 2011-10-21
• Study First Posted: 2011-10-24
• Last Update Posted: 2011-10-24
• Primary Completion: 2013-10
• Study Completion: 2013-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 410

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Conventional sutures	Conventional non-coated surgical sutures	-
Antiseptic sutures	Triclosan	-

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Rambam Health Care Campus, Depatment of cardiac surgery; 🇮🇱 Haifa, Israel