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

NCT01457859 | Unknown Phase 4

• 1 other identifier: RMB-0228.CTIL
• Study Type: interventional
• Target: 410
• Locations: 1 country
• Sites: 1

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.

Conditions

Complication of Coronary Artery Bypass Graft; Surgical Wound Infection

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Antibiotics administration

  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

Study Arms (2)

Conventional sutures

ACTIVE COMPARATOR

Other: Conventional non-coated surgical sutures

Antiseptic sutures

EXPERIMENTAL

Drug: Triclosan

Interventions

Triclosan DRUG

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

Antiseptic sutures

Conventional non-coated surgical sutures OTHER

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

Conventional sutures

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Known allergy or intolerance to triclosan
• Different surgical prophylactic antibiotic regimen than common in the department.
• Continuous preoperative and predicted postoperative antibiotic treatment.

Sponsors & Collaborators

• Rambam Health Care Campus: lead

Study Sites (1)

Rambam Health Care Campus, Depatment of cardiac surgery

Haifa, 31096, Israel

Location

MeSH Terms

Conditions

Surgical Wound Infection

Interventions

Triclosan

Condition Hierarchy (Ancestors)

Wound Infection; Infections; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Phenyl Ethers; Ethers; Organic Chemicals; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Study Officials

• Liran Shani, MD

  Rambam Health Care Campus

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Liran Shani, MD

CONTACT

l_shani@rambam.health.gov.il

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Cardiac surgery resident

Study Record Dates

• First Submitted: October 16, 2011
• First Posted: October 24, 2011
• Study Start: October 1, 2011
• Primary Completion: October 1, 2013
• Study Completion: October 1, 2013
• Last Updated: October 24, 2011

Record last verified: 2011-10

Locations

IL (1)