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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01101789
Recruitment Status : Completed
First Posted : April 12, 2010
Last Update Posted : October 14, 2015
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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.

Condition or disease Intervention/treatment
Surgical Wound Infection Procedure: triclosan coated suture for surgical wound closure Procedure: regular sutures for surgical wound closure

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 276 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Triclosan Coated Suture Wound Closure for Peripheral Vascular Surgery: a Prospective Multicenter Study
Study Start Date : April 2010
Primary Completion Date : January 2011
Study Completion Date : January 2011

Resource links provided by the National Library of Medicine

Drug Information available for: Triclosan
U.S. FDA Resources

Arms and Interventions

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


Outcome Measures

Primary Outcome Measures :
  1. surgical wound infection [ Time Frame: one month after surgical procedure ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • patient undergoing peripheral vascular surgery procedure

Exclusion Criteria:

  • patients refusal
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01101789


Locations
Finland
North Carelia central hospital
Joensuu, Finland, 80210
Sponsors and Collaborators
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
More Information

Responsible Party: Sanna Kouhia, MD, North Karelia Central Hospital
ClinicalTrials.gov Identifier: NCT01101789     History of Changes
Other Study ID Numbers: NKCH-surg-006
First Posted: April 12, 2010    Key Record Dates
Last Update Posted: October 14, 2015
Last Verified: October 2015

Keywords provided by Sanna Kouhia, North Karelia Central Hospital:
surgical wound infection
triclosan-coated suture

Additional relevant MeSH terms:
Wounds and Injuries
Wound Infection
Surgical Wound
Surgical Wound Infection
Infection
Postoperative Complications
Pathologic Processes
Triclosan
Anti-Infective Agents, Local
Anti-Infective Agents
Fatty Acid Synthesis Inhibitors
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents