Effects of Triclosan-coated Sutures in Cardiac Surgery

Phase 4

Completed

• Conditions: Postoperative Wound Infection
• Interventions: Device: Triclosan coated sutures

• Registration Number: NCT01212315
• Lead Sponsor: Sahlgrenska University Hospital, Sweden

Brief 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.

Study Timeline

• Study Start: 2009-03
• Study First Submitted: 2010-09-29
• Study First Submitted QC: 2010-09-29
• Study First Posted: 2010-09-30
• Primary Completion: 2012-06
• Study Completion: 2012-06
• Status Verified: 2012-12
• Last Update Submitted: 2012-12-19
• Last Update Posted: 2012-12-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 392

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group A	Triclosan coated sutures	Triclosan coated sutures (Vicryl Plus / Monocryl Plus) is used for wound closure

Primary Outcome Measures

Name	Time	Method
Proportion of subjects with leg wound infection.	Within 60 days after heartsurgery	Primary endpoint is postoperative leg wound infection within 60 days after surgery according to the definition of Center for Disease Control.

Secondary Outcome Measures

Name	Time	Method
Culture-proven and antibiotic-treated wound infection after heart surgery	Within 60 days after heart surgery

Trial Locations

Locations (1)

Dep of Cardiovascular Surgery and Anesthesia, Sahlgrenska Univerity Hospital; 🇸🇪 Gothenburg, Sweden