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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00990392
Recruitment Status : Withdrawn (Change of practice to antibiotic impregnated catheters and large study published showing their efficacy. Made topical antibiotics obselete.)
First Posted : October 6, 2009
Last Update Posted : May 29, 2015
Sponsor:
Information provided by (Responsible Party):
Steve Reynolds, Fraser Health

Brief Summary:
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 or disease Intervention/treatment
Blood Stream Infections Skin Diseases, Infectious Drug: Polysporin Triple Therapy ointment Other: Petroleum Jelly

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  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Pilot Study: Topical Antibiotics for Prevention of ICU Central Line Infections
Study Start Date : November 2009
Primary Completion Date : January 2011
Study Completion Date : January 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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 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



Primary Outcome Measures :
  1. Overall number of line related infections (local and blood borne) [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Length of ICU stay [ Time Frame: 7 months ]
  2. Length of hospital stay [ Time Frame: 7 months ]
  3. Prevalence of methicillin-resistant Staphylococcus Aureus (MRSA) [ Time Frame: 12 months ]


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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Publications:
Responsible Party: Steve Reynolds, Critical care Physician, Fraser Health
ClinicalTrials.gov Identifier: NCT00990392     History of Changes
Other Study ID Numbers: Kerrie-333333
First Posted: October 6, 2009    Key Record Dates
Last Update Posted: May 29, 2015
Last Verified: May 2015

Keywords provided by Steve Reynolds, 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:
Infection
Communicable Diseases
Skin Diseases
Skin Diseases, Infectious
Anti-Bacterial Agents
Polymyxins
Bacitracin
Polymyxin B
Gramicidin
Antibiotics, Antitubercular
Petrolatum
Anti-Infective Agents
Antitubercular Agents
Anti-Infective Agents, Local
Emollients
Dermatologic Agents