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

NCT ID: NCT01101789

Last Updated: 2015-10-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

276 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-04-30

Study Completion Date

2011-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Surgical Wound Infection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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triclosan

triclosan-coated sutures

Group Type ACTIVE_COMPARATOR

triclosan coated suture for surgical wound closure

Intervention Type PROCEDURE

triclosan coated suture for surgical wound closure

control

sutures without triclosan-coating

Group Type PLACEBO_COMPARATOR

regular sutures for surgical wound closure

Intervention Type PROCEDURE

Interventions

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triclosan coated suture for surgical wound closure

triclosan coated suture for surgical wound closure

Intervention Type PROCEDURE

regular sutures for surgical wound closure

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* patient undergoing peripheral vascular surgery procedure

Exclusion Criteria

* patients refusal
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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North Karelia Central Hospital

OTHER

Sponsor Role lead

Responsible Party

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Sanna Kouhia

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Johanna Turtiainen, MD

Role: STUDY_DIRECTOR

North Karelia Central Hospital

Kimmo Makinen

Role: PRINCIPAL_INVESTIGATOR

Kuopio University Hospital

Maarit Venermo

Role: PRINCIPAL_INVESTIGATOR

Helsinki University Central Hospital

Eija Saimanen

Role: PRINCIPAL_INVESTIGATOR

South Carelia Central Hospital

Ilkka Uurto

Role: STUDY_DIRECTOR

Tampere University Hospital

Locations

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North Carelia central hospital

Joensuu, Joensuu, Finland

Site Status

Countries

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Finland

Other Identifiers

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NKCH-surg-006

Identifier Type: -

Identifier Source: org_study_id

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