Effects of Triclosan-coated Sutures in Cardiac Surgery

Postoperative Wound Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01212315
• Other study ID #: 001
• Status: Completed
• Phase: Phase 4
• First received: September 29, 2010
• Last updated: December 19, 2012
• Start date: March 2009
• Est. completion date: June 2012

Study information

• Verified date: December 2012
• Source: Sahlgrenska University Hospital, Sweden
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Swedish National Council on Medical Ethics
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• 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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Infection
• Postoperative Wound Infection
• Surgical Wound Infection
• Wound Infection

Intervention

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.

Locations

Country	Name	City	State
Sweden	Dep of Cardiovascular Surgery and Anesthesia, Sahlgrenska Univerity Hospital	Gothenburg

Sponsors (1)

Lead Sponsor	Collaborator
Sahlgrenska University Hospital, Sweden

Country where clinical trial is conducted

Sweden, 

Outcome

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