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

Primary Purpose

Blood Stream Infections, Skin Diseases, Infectious

Status
Withdrawn
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Polysporin Triple Therapy ointment
Petroleum Jelly
Sponsored by
Fraser Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Blood Stream Infections focused on measuring Blood stream infections, Catheter related infections, Central venous catheter related infections, Line sepsis, Topical antibiotics, Bacitracin, Polymixin, Gramicidin, Polysporin Triple Therapy, Intensive care unit

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Royal Columbian Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Polysporin Triple Therapy

Placebo

Arm Description

Polysporin Triple Therapy ointment applied to the insertion point at the time of CVC placement and twice within the first week.

Petroleum jelly

Outcomes

Primary Outcome Measures

Overall number of line related infections (local and blood borne)

Secondary Outcome Measures

Length of ICU stay
Length of hospital stay
Prevalence of methicillin-resistant Staphylococcus Aureus (MRSA)

Full Information

First Posted
October 5, 2009
Last Updated
May 28, 2015
Sponsor
Fraser Health
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1. Study Identification

Unique Protocol Identification Number
NCT00990392
Brief Title
Topical Antibiotics for Prevention of Intensive Care Unit (ICU) Central Line Infections
Acronym
ToPICL
Official Title
Pilot Study: Topical Antibiotics for Prevention of ICU Central Line Infections
Study Type
Interventional

2. Study Status

Record Verification Date
May 2015
Overall Recruitment Status
Withdrawn
Why Stopped
Change of practice to antibiotic impregnated catheters and large study published showing their efficacy. Made topical antibiotics obselete.
Study Start Date
November 2009 (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
Fraser Health

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Blood Stream Infections, Skin Diseases, Infectious
Keywords
Blood stream infections, Catheter related infections, Central venous catheter related infections, Line sepsis, Topical antibiotics, Bacitracin, Polymixin, Gramicidin, Polysporin Triple Therapy, Intensive care unit

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Polysporin Triple Therapy
Arm Type
Experimental
Arm Description
Polysporin Triple Therapy ointment applied to the insertion point at the time of CVC placement and twice within the first week.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Petroleum jelly
Intervention Type
Drug
Intervention Name(s)
Polysporin Triple Therapy ointment
Other Intervention Name(s)
Polysporin Triple Therapy (gramicidin, polymixin, bacitracin)
Intervention Description
Polysporin Triple Therapy ointment applied to the insertion point at the time of CVC placement and twice within the first week.
Intervention Type
Other
Intervention Name(s)
Petroleum Jelly
Other Intervention Name(s)
Vaseline
Intervention Description
Petroleum jelly applied to the insertion point at the time of CVC placement and twice within the first week.
Primary Outcome Measure Information:
Title
Overall number of line related infections (local and blood borne)
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Length of ICU stay
Time Frame
7 months
Title
Length of hospital stay
Time Frame
7 months
Title
Prevalence of methicillin-resistant Staphylococcus Aureus (MRSA)
Time Frame
12 months

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Steven Reynolds, MD
Organizational Affiliation
Fraser Health Authority
Official's Role
Principal Investigator
Facility Information:
Facility Name
Royal Columbian Hospital
City
New Westminster
State/Province
British Columbia
ZIP/Postal Code
V3L 1A1
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
12506149
Citation
Lok CE, Stanley KE, Hux JE, Richardson R, Tobe SW, Conly J. Hemodialysis infection prevention with polysporin ointment. J Am Soc Nephrol. 2003 Jan;14(1):169-79. doi: 10.1097/01.asn.0000038688.76195.a4.
Results Reference
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PubMed Identifier
18413621
Citation
James MT, Conley J, Tonelli M, Manns BJ, MacRae J, Hemmelgarn BR; Alberta Kidney Disease Network. Meta-analysis: antibiotics for prophylaxis against hemodialysis catheter-related infections. Ann Intern Med. 2008 Apr 15;148(8):596-605. doi: 10.7326/0003-4819-148-8-200804150-00004.
Results Reference
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Learn more about this trial

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

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