Effects of Triclosan-coated Sutures in Cardiac Surgery
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 Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Triclosan-coated Sutures in Cardiac Surgery:Effects on Leg Wound Infections and Costs|
- Proportion of subjects with leg wound infection. [ Time Frame: Within 60 days after heartsurgery ] [ Designated as safety issue: No ]Primary endpoint is postoperative leg wound infection within 60 days after surgery according to the definition of Center for Disease Control.
- Culture-proven and antibiotic-treated wound infection after heart surgery [ Time Frame: Within 60 days after heart surgery ] [ Designated as safety issue: No ]
|Study Start Date:||March 2009|
|Study Completion Date:||June 2012|
|Primary Completion Date:||June 2012 (Final data collection date for primary outcome measure)|
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.
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.
|Dep of Cardiovascular Surgery and Anesthesia, Sahlgrenska Univerity Hospital|
|Gothenburg, Sweden, 413 45|
|Principal Investigator:||Anders Jeppsson, MD PhD||Sahlgrenska Univerity Hospital|