Effects of Triclosan-coated Sutures in Cardiac Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01212315
Recruitment Status : Completed
First Posted : September 30, 2010
Last Update Posted : December 20, 2012
Information provided by (Responsible Party):
Anders Jeppssons, Sahlgrenska University Hospital, Sweden

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Postoperative Wound Infection Device: Triclosan coated sutures Phase 4

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  (Clinical Trial)
Actual Enrollment : 392 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Triclosan-coated Sutures in Cardiac Surgery:Effects on Leg Wound Infections and Costs
Study Start Date : March 2009
Actual Primary Completion Date : June 2012
Actual Study Completion Date : June 2012

Resource links provided by the National Library of Medicine

Drug Information available for: Triclosan

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

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. Culture-proven and antibiotic-treated wound infection after heart surgery [ Time Frame: Within 60 days after heart surgery ]

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01212315

Dep of Cardiovascular Surgery and Anesthesia, Sahlgrenska Univerity Hospital
Gothenburg, Sweden, 413 45
Sponsors and Collaborators
Sahlgrenska University Hospital, Sweden
Principal Investigator: Anders Jeppsson, MD PhD Sahlgrenska Univerity Hospital

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Anders Jeppssons, Professor, Cardiothoracic surgery, Sahlgrenska University Hospital, Sweden Identifier: NCT01212315     History of Changes
Other Study ID Numbers: 001
First Posted: September 30, 2010    Key Record Dates
Last Update Posted: December 20, 2012
Last Verified: December 2012

Keywords provided by Anders Jeppssons, Sahlgrenska University Hospital, Sweden:
Wound infection

Additional relevant MeSH terms:
Wound Infection
Surgical Wound Infection
Postoperative Complications
Pathologic Processes
Anti-Infective Agents, Local
Anti-Infective Agents
Fatty Acid Synthesis Inhibitors
Hypolipidemic Agents
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents