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

Primary Purpose

Complication of Coronary Artery Bypass Graft, Surgical Wound Infection

Status
Unknown status
Phase
Phase 4
Locations
Israel
Study Type
Interventional
Intervention
Triclosan
Conventional non-coated surgical sutures
Sponsored by
Rambam Health Care Campus
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Complication of Coronary Artery Bypass Graft

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Rambam Health Care Campus, Depatment of cardiac surgery

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Conventional sutures

Antiseptic sutures

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Antibiotics administration
Amount of administered antibiotic for leg wound infection after surgery
Hospital Length of stay
Incidence of hospital re-admission due to leg wound infection

Full Information

First Posted
October 16, 2011
Last Updated
October 21, 2011
Sponsor
Rambam Health Care Campus
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1. Study Identification

Unique Protocol Identification Number
NCT01457859
Brief Title
Effectiveness of Triclosan Coated Sutures in Preventing Leg Wound Infection After Coronary Artery Bypass Surgery
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2011
Overall Recruitment Status
Unknown status
Study Start Date
October 2011 (undefined)
Primary Completion Date
October 2013 (Anticipated)
Study Completion Date
October 2013 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rambam Health Care Campus

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Complication of Coronary Artery Bypass Graft, Surgical Wound Infection

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
410 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Conventional sutures
Arm Type
Active Comparator
Arm Title
Antiseptic sutures
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Triclosan
Intervention Description
Triclosan coated surgical sewing threads (VICRYL+ and MONOCRYL+) applied for leg wound closure after CABG
Intervention Type
Other
Intervention Name(s)
Conventional non-coated surgical sutures
Intervention Description
Conventional non-coated surgical sewing threads (POLYSORB and BIOSYN) will be applied after CABG for leg wound closure
Primary Outcome Measure Information:
Title
leg wound infection
Description
Proportion of subjects with leg wound infection in research versus control group within 45 days of surgery according to CDC SSI criteria
Time Frame
Up to 45 days postsurgery
Secondary Outcome Measure Information:
Title
Antibiotics administration
Description
Amount of administered antibiotic for leg wound infection after surgery
Time Frame
Up to 45 days postsurgery
Title
Hospital Length of stay
Time Frame
Average of 7 days postsurgery
Title
Incidence of hospital re-admission due to leg wound infection
Time Frame
Within 45 days postsurgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Liran Shani, MD
Email
l_shani@rambam.health.gov.il
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Liran Shani, MD
Organizational Affiliation
Rambam Health Care Campus
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rambam Health Care Campus, Depatment of cardiac surgery
City
Haifa
ZIP/Postal Code
31096
Country
Israel
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Liran Shani, MD
Email
l_shani@rambam.health.gov.il
First Name & Middle Initial & Last Name & Degree
Liran Shani, MD

12. IPD Sharing Statement

Learn more about this trial

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

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