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

Surgical Wound Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01457859
• Other study ID #: RMB-0228.CTIL
• Status: Not yet recruiting
• Phase: Phase 4
• First received: October 16, 2011
• Last updated: October 21, 2011
• Start date: October 2011
• Est. completion date: October 2013

Study information

• Verified date: October 2011
• Source: Rambam Health Care Campus
• Contact: Liran Shani, MD
• Email: l_shani[@]rambam.health.gov.il
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 410
• Est. completion date: October 2013
• Est. primary completion date: October 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Complication of Coronary Artery Bypass Graft
• Infection
• Surgical Wound Infection
• Wound Infection

Intervention

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

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

Locations

Country	Name	City	State
Israel	Rambam Health Care Campus, Depatment of cardiac surgery	Haifa

Sponsors (1)

Lead Sponsor	Collaborator
Rambam Health Care Campus

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Antibiotics administration	Amount of administered antibiotic for leg wound infection after surgery	Up to 45 days postsurgery	No
Secondary	Hospital Length of stay		Average of 7 days postsurgery	No
Secondary	Incidence of hospital re-admission due to leg wound infection		Within 45 days postsurgery	No