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Effects of Triclosan-coated Sutures in Cardiac Surgery

NCT01212315 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 392

Last updated 2012-12-20

No results posted yet for this study

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.

Conditions

  • Postoperative Wound Infection

Interventions

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.

Sponsors & Collaborators

  • Sahlgrenska University Hospital

    lead OTHER

Principal Investigators

  • Anders Jeppsson, MD PhD · Sahlgrenska Univerity Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-03-31
Primary Completion
2012-06-30
Completion
2012-06-30

Countries

  • Sweden

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01212315 on ClinicalTrials.gov