Topical Antibiotics for Prevention of Intensive Care Unit (ICU) Central Line Infections (ToPICL)

May 28, 2015 updated by: Steve Reynolds, Fraser Health

Pilot Study: Topical Antibiotics for Prevention of ICU Central Line Infections

The purpose of the study is to determine if the overall central venous catheter related infection rate can be reduced by the application of Polysporin Triple Therapy ointment to the insertion site.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

Previous studies in the dialysis population have found a reduction in local and system central venous catheter related infections with the application of topical antibiotics to the insertion point. One such study found a mortality benefit with Polysporin Triple Therapy ointment. We intend to determine if this preparation can reduce overall line infection rates in the ICU environment through its application at the time of line insertion and twice more the following week.

Study Type

Interventional

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

  • Canada
    • British Columbia
      • New Westminster, British Columbia, Canada, V3L 1A1
        • Royal Columbian 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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • all patients admitted to the ICU requiring a central venous catheter

Exclusion Criteria:

  • previous line infection during same ICU stay
  • CVC for hemodialysis

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: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Polysporin Triple Therapy
Polysporin Triple Therapy ointment applied to the insertion point at the time of CVC placement and twice within the first week.
Drug: Polysporin Triple Therapy ointment
Polysporin Triple Therapy ointment applied to the insertion point at the time of CVC placement and twice within the first week.
Other Names:
  • Polysporin Triple Therapy (gramicidin, polymixin, bacitracin)
Placebo Comparator: Placebo
Petroleum jelly
Other: Petroleum Jelly
Petroleum jelly applied to the insertion point at the time of CVC placement and twice within the first week.
Other Names:
  • Vaseline

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Overall number of line related infections (local and blood borne)
Time Frame: 6 months
6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Length of ICU stay
Time Frame: 7 months
7 months
Length of hospital stay
Time Frame: 7 months
7 months
Prevalence of methicillin-resistant Staphylococcus Aureus (MRSA)
Time Frame: 12 months
12 months

Collaborators and Investigators

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

Sponsor

Fraser Health

Investigators

  • Principal Investigator: Steven Reynolds, MD, Fraser Health Authority

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

November 1, 2009

Primary Completion (Actual)

January 1, 2011

Study Completion (Actual)

January 1, 2011

Study Registration Dates

First Submitted

October 5, 2009

First Submitted That Met QC Criteria

October 5, 2009

First Posted (Estimate)

October 6, 2009

Study Record Updates

Last Update Posted (Estimate)

May 29, 2015

Last Update Submitted That Met QC Criteria

May 28, 2015

Last Verified

May 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Kerrie-333333

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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