Effects of Triclosan-coated Sutures in Cardiac Surgery

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Postoperative Wound Infection

Intervention / Treatment
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* Device: Triclosan coated sutures


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control group<br>Ordinary sutures (Vicryl / Monocryl) is used for wound closure | |
| Active Comparator: Group A<br>Triclosan coated sutures (Vicryl Plus / Monocryl Plus) is used for wound closure | Device: Triclosan coated sutures<br>* 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.<br>* Other names: Vicryl Plus suture;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of subjects with leg wound infection. | 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 | Measure Description | Time Frame |
| --- | --- | --- |
| Culture-proven and antibiotic-treated wound infection after heart surgery |  | Within 60 days after heart surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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SSI, Wound infection, Suture