Effects of Triclosan-coated Sutures in Cardiac Surgery

December 19, 2012 updated by: Anders Jeppssons, Sahlgrenska University Hospital, Sweden

Triclosan-coated Sutures in Cardiac Surgery:Effects on Leg Wound Infections and Costs

The purpose of this study is to assess if triclosan-coated sutures reduces wound infections after saphenous vein harvesting in CABG patients. Secondary objectives are the effect triclosan-coated sutures on sternal wound infections and a cost analysis.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The role of the suture material for the development of postoperative wound infection has been debated for many years. It has been reported that fewer bacteria adhere to monofilament polypropylene than braided polyester sutures in vitro but the results are opposed by a non-randomized clinical study where the use of monofilament sutures was identified as an independent risk factor for leg wound infections after CABG.

Study Type

Interventional

Enrollment (Actual)

392

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Gothenburg, Sweden, 413 45
        • Dep of Cardiovascular Surgery and Anesthesia, Sahlgrenska Univerity Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients undergoing elective CABG at Sahlgrenska University Hospital with intended use of saphenous vein graft are included.

Exclusion Criteria:

  • Patients with on-going sepsis or septicaemia, bacterial infections or known allergy to triclosan are excluded.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
NO_INTERVENTION: Control group
Ordinary sutures (Vicryl / Monocryl) is used for wound closure
ACTIVE_COMPARATOR: Group A
Triclosan coated sutures (Vicryl Plus / Monocryl Plus) is used for wound closure
Device: Triclosan coated sutures
Subcutaneous and cutaneous sutures coated with triclosan (Vicryl Plus / Monocryl Plus) are used to close the incisions after vein harvesting and sternotomy. All wounds are inspected before discharge from hospital and the patients are instructed to contact the study coordinator if any suspected infection occurs. In addition, all patients are controlled after thirty days by a nurse and contacted by telephone sixty days after surgery to assess postoperative infections by a predefined questionnaire. Infection symptoms are graded according to the Asepsis score and the CDC classification. Patient records including bacterial cultures and antibiotic treatment are collected for all patients with suspected infections.
Other Names:
  • Monocryl Plus suture
  • Vicryl Plus suture

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of subjects with leg wound infection.
Time Frame: Within 60 days after heartsurgery
Primary endpoint is postoperative leg wound infection within 60 days after surgery according to the definition of Center for Disease Control.
Within 60 days after heartsurgery

Secondary Outcome Measures

Outcome Measure
Time Frame
Culture-proven and antibiotic-treated wound infection after heart surgery
Time Frame: Within 60 days after heart surgery
Within 60 days after heart surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sahlgrenska University Hospital, Sweden

Investigators

  • Principal Investigator: Anders Jeppsson, MD PhD, Sahlgrenska Univerity Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2009

Primary Completion (ACTUAL)

June 1, 2012

Study Completion (ACTUAL)

June 1, 2012

Study Registration Dates

First Submitted

September 29, 2010

First Submitted That Met QC Criteria

September 29, 2010

First Posted (ESTIMATE)

September 30, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

December 20, 2012

Last Update Submitted That Met QC Criteria

December 19, 2012

Last Verified

December 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 001 (NavyGHB)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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