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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

Status
UNKNOWN
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01457859
Enrollment
410
Registered
2011-10-24
Start date
2011-10-31
Completion date
2013-10-31
Last updated
2011-10-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Complication of Coronary Artery Bypass Graft, Surgical Wound Infection

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.

Interventions

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

OTHERConventional non-coated surgical sutures

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

Sponsors

Rambam Health Care Campus
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

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

Secondary

MeasureTime frameDescription
Antibiotics administrationUp to 45 days postsurgeryAmount of administered antibiotic for leg wound infection after surgery
Hospital Length of stayAverage of 7 days postsurgery
Incidence of hospital re-admission due to leg wound infectionWithin 45 days postsurgery

Countries

Israel

Contacts

Primary ContactLiran Shani, MD
l_shani@rambam.health.gov.il

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026