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

Primary Purpose

Surgical Wound Infection

Status

Completed

Phase

Not Applicable

Locations

Finland

Study Type

Interventional

Intervention

triclosan coated suture for surgical wound closure

regular sutures for surgical wound closure

About this trial

This is an interventional treatment trial for Surgical Wound Infection focused on measuring surgical wound infection, triclosan-coated suture

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

patient undergoing peripheral vascular surgery procedure

Exclusion Criteria:

patients refusal

Sites / Locations

North Carelia central hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

triclosan

control

Arm Description

triclosan-coated sutures

sutures without triclosan-coating

Outcomes

Primary Outcome Measures

surgical wound infection

Secondary Outcome Measures

Full Information

NCT ID

NCT01101789

First Posted

April 8, 2010

Last Updated

October 11, 2015

Sponsor

North Karelia Central Hospital

1. Study Identification

Unique Protocol Identification Number

NCT01101789

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2015

Overall Recruitment Status

Completed

Study Start Date

April 2010 (undefined)

Primary Completion Date

January 2011 (Actual)

Study Completion Date

January 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

North Karelia Central Hospital

4. Oversight

Data Monitoring Committee

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Surgical Wound Infection

Keywords

surgical wound infection, triclosan-coated suture

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Investigator

Allocation

Randomized

Enrollment

276 (Actual)

8. Arms, Groups, and Interventions

Arm Title

triclosan

Arm Type

Active Comparator

Arm Description

triclosan-coated sutures

Arm Title

control

Arm Type

Placebo Comparator

Arm Description

sutures without triclosan-coating

Intervention Type

Procedure

Intervention Name(s)

triclosan coated suture for surgical wound closure

Intervention Description

triclosan coated suture for surgical wound closure

Intervention Type

Procedure

Intervention Name(s)

regular sutures for surgical wound closure

Primary Outcome Measure Information:

Title

surgical wound infection

Time Frame

one month after surgical procedure

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

100 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: patient undergoing peripheral vascular surgery procedure Exclusion Criteria: patients refusal

Overall Study Officials: