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

This study has been terminated.
(Change of practice to antibiotic impregnated catheters and large study published showing their efficacy. Made topical antibiotics obselete.)
Sponsor:
Information provided by:
Fraser Health
ClinicalTrials.gov Identifier:
NCT00990392
First received: October 5, 2009
Last updated: June 22, 2011
Last verified: June 2011
History of Changes
  Purpose

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.


Condition Intervention
Blood Stream Infections
Skin Diseases, Infectious
 Drug: Polysporin Triple Therapy ointment
Other: Petroleum Jelly

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Pilot Study: Topical Antibiotics for Prevention of ICU Central Line Infections

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Fraser Health:

Primary Outcome Measures:
  • Overall number of line related infections (local and blood borne) [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Length of ICU stay [ Time Frame: 7 months ] [ Designated as safety issue: No ]
  • Length of hospital stay [ Time Frame: 7 months ] [ Designated as safety issue: No ]
  • Prevalence of methicillin-resistant Staphylococcus Aureus (MRSA) [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 140
Study Start Date: November 2009
Study Completion Date: January 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: Vaseline

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00990392

Locations
Canada, British Columbia
Royal Columbian Hospital
New Westminster, British Columbia, Canada, V3L 1A1
Sponsors and Collaborators
Fraser Health
Investigators
Principal Investigator: Steven Reynolds, MD Fraser Health Authority
  More Information

Additional Information:
Canadian Central Venous Catheter Infection Surveillance Data  This link exits the ClinicalTrials.gov site

Publications:

Responsible Party: Dr. Steven Reynolds, Fraser Health
ClinicalTrials.gov Identifier: NCT00990392     History of Changes
Other Study ID Numbers: Kerrie-333333
Study First Received: October 5, 2009
Last Updated: June 22, 2011
Health Authority: Canada: Ethics Review Committee

Keywords provided by Fraser Health:
Blood stream infections
Catheter related infections
Central venous catheter related infections
Line sepsis
Topical antibiotics
 Bacitracin
Polymixin
Gramicidin
Polysporin Triple Therapy
Intensive care unit

Additional relevant MeSH terms:
Communicable Diseases
Infection
Skin Diseases
Skin Diseases, Infectious
Anti-Bacterial Agents
Bacitracin
Gramicidin
Polymyxins
 Polymyxin B
Petrolatum
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Anti-Infective Agents, Local
Emollients
Dermatologic Agents

ClinicalTrials.gov processed this record on May 19, 2013