Postoperative Wound Infection Clinical Trial
Official title:
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.
Status | Completed |
Enrollment | 392 |
Est. completion date | June 2012 |
Est. primary completion date | June 2012 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 85 Years |
Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Sweden | Dep of Cardiovascular Surgery and Anesthesia, Sahlgrenska Univerity Hospital | Gothenburg |
Lead Sponsor | Collaborator |
---|---|
Sahlgrenska University Hospital, Sweden |
Sweden,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | No |
Secondary | Culture-proven and antibiotic-treated wound infection after heart surgery | Within 60 days after heart surgery | No |
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