Effects of Triclosan-coated Sutures in Cardiac Surgery

Sahlgrenska University Hospital392 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

392

Conditions

Postoperative Wound Infection

Interventions

Triclosan coated suturesDEVICE

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 85 Years

Medical Language ↔ Plain English

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.

Locations (1)

Dep of Cardiovascular Surgery and Anesthesia, Sahlgrenska Univerity Hospital

Gothenburg, Sweden

Outcomes

Primary Outcomes

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.

Time frame: Within 60 days after heartsurgery

Secondary Outcomes

Culture-proven and antibiotic-treated wound infection after heart surgery

Time frame: Within 60 days after heart surgery

Data from ClinicalTrials.gov

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