Triclosan Coated Suture Wound Closure for Peripheral Vascular Surgery: a Prospective Multicenter Study

October 11, 2015 updated by: Sanna Kouhia, North Karelia Central Hospital
This is a prospective randomized multicenter study which purpose is to determine whether triclosan-coated sutures for wound closure after lower limb vascular surgery would reduce the incidence of surgical wound infections.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

276

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Finland
      • Joensuu, Finland, 80210
        • North Carelia Central Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • patient undergoing peripheral vascular surgery procedure

Exclusion Criteria:

  • patients refusal

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: triclosan
triclosan-coated sutures
Procedure: triclosan coated suture for surgical wound closure
triclosan coated suture for surgical wound closure
Placebo Comparator: control
sutures without triclosan-coating
Procedure: regular sutures for surgical wound closure

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
surgical wound infection
Time Frame: one month after surgical procedure
one month after surgical procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

North Karelia Central Hospital

Investigators

  • Study Director: Johanna Turtiainen, MD, North Karelia Central Hospital
  • Principal Investigator: Kimmo Makinen, Kuopio University Hospital
  • Principal Investigator: Maarit Venermo, Helsinki University Central Hospital
  • Principal Investigator: Eija Saimanen, South Carelia Central Hospital
  • Study Director: Ilkka Uurto, Tampere University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2010

Primary Completion (Actual)

January 1, 2011

Study Completion (Actual)

January 1, 2011

Study Registration Dates

First Submitted

April 8, 2010

First Submitted That Met QC Criteria

April 8, 2010

First Posted (Estimate)

April 12, 2010

Study Record Updates

Last Update Posted (Estimate)

October 14, 2015

Last Update Submitted That Met QC Criteria

October 11, 2015

Last Verified

October 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NKCH-surg-006

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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