NCT01212315

Effects of Triclosan-coated Sutures in Cardiac Surgery

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 392 (actual)
• Sponsor: Sahlgrenska University Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Postoperative Wound Infection

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2009-03-01
• Primary completion: 2012-06-01
• Completion: 2012-06-01
• First posted: 2010-09-30
• Last updated: 2012-12-20

Locations

1 site across 1 country: Sweden