NCT01101789

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
276

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2010

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2010

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

April 8, 2010

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 12, 2010

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2011

Completed
Last Updated

October 14, 2015

Status Verified

October 1, 2015

Enrollment Period

9 months

First QC Date

April 8, 2010

Last Update Submit

October 11, 2015

Conditions

Surgical Wound Infection

Keywords

surgical wound infectiontriclosan-coated suture

Outcome Measures

Primary Outcomes (1)

  • surgical wound infection

    one month after surgical procedure

Study Arms (2)

triclosan

ACTIVE COMPARATOR

triclosan-coated sutures

Procedure: triclosan coated suture for surgical wound closure

control

PLACEBO COMPARATOR

sutures without triclosan-coating

Procedure: regular sutures for surgical wound closure

Interventions

triclosan coated suture for surgical wound closurePROCEDURE

triclosan coated suture for surgical wound closure

triclosan
regular sutures for surgical wound closurePROCEDURE
control

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patient undergoing peripheral vascular surgery procedure

You may not qualify if:

  • patients refusal

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

North Carelia central hospital

Joensuu, Joensuu, 80210, Finland

Location

MeSH Terms

Conditions

Surgical Wound Infection

Condition Hierarchy (Ancestors)

Wound InfectionInfectionsPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Johanna Turtiainen, MD

    North Karelia Central Hospital

    STUDY DIRECTOR

  • Kimmo Makinen

    Kuopio University Hospital

    PRINCIPAL INVESTIGATOR

  • Maarit Venermo

    Helsinki University Central Hospital

    PRINCIPAL INVESTIGATOR

  • Eija Saimanen

    South Carelia Central Hospital

    PRINCIPAL INVESTIGATOR

  • Ilkka Uurto

    Tampere University Hospital

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

April 8, 2010

First Posted

April 12, 2010

Study Start

April 1, 2010

Primary Completion

January 1, 2011

Study Completion

January 1, 2011

Last Updated

October 14, 2015

Record last verified: 2015-10

Locations

FI(1)