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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

October 5, 2009
June 22, 2011
November 2009
January 2011   (final data collection date for primary outcome measure)
Overall number of line related infections (local and blood borne) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00990392 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Topical Antibiotics for Prevention of Intensive Care Unit (ICU) Central Line Infections
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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
  • Blood Stream Infections
  • Skin Diseases, Infectious
  • 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)
  • 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
  • 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.
    Intervention: Drug: Polysporin Triple Therapy ointment
  • Placebo Comparator: Placebo
    Petroleum jelly
    Intervention: Other: Petroleum Jelly

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
140
January 2011
January 2011   (final data collection date for primary outcome measure)

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
Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT00990392
Kerrie-333333
Yes
Dr. Steven Reynolds, Fraser Health
Fraser Health
Not Provided
Principal Investigator: Steven Reynolds, MD Fraser Health Authority
Fraser Health
June 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP