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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01212315
Other study ID # 001
Secondary ID
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


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
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