NCT00990392

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Nov 2009

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 5, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 6, 2009

Completed
26 days until next milestone

Study Start

First participant enrolled

November 1, 2009

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2011

Completed
Last Updated

May 29, 2015

Status Verified

May 1, 2015

Enrollment Period

1.2 years

First QC Date

October 5, 2009

Last Update Submit

May 28, 2015

Conditions

Blood Stream InfectionsSkin Diseases, Infectious

Keywords

Blood stream infectionsCatheter related infectionsCentral venous catheter related infectionsLine sepsisTopical antibioticsBacitracinPolymixinGramicidinPolysporin Triple TherapyIntensive care unit

Outcome Measures

Primary Outcomes (1)

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

    6 months

Secondary Outcomes (3)

  • Length of ICU stay

    7 months

  • Length of hospital stay

    7 months

  • Prevalence of methicillin-resistant Staphylococcus Aureus (MRSA)

    12 months

Study Arms (2)

Polysporin Triple Therapy

EXPERIMENTAL

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

Placebo

PLACEBO COMPARATOR

Petroleum jelly

Other: Petroleum Jelly

Interventions

Polysporin Triple Therapy ointmentDRUG

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

Also known as: Polysporin Triple Therapy (gramicidin, polymixin, bacitracin)
Polysporin Triple Therapy
Petroleum JellyOTHER

Petroleum jelly applied to the insertion point at the time of CVC placement and twice within the first week.

Also known as: Vaseline
Placebo

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Royal Columbian Hospital

New Westminster, British Columbia, V3L 1A1, Canada

Location

Related Publications (2)

  • 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.

    PMID: 12506149BACKGROUND

  • 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.

    PMID: 18413621BACKGROUND

MeSH Terms

Conditions

Skin Diseases, InfectiousCatheter-Related Infections

Interventions

GramicidinBacitracinPetrolatum

Condition Hierarchy (Ancestors)

InfectionsSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

TyrothricinPeptides, CyclicMacrocyclic CompoundsPolycyclic CompoundsPeptidesAmino Acids, Peptides, and ProteinsPore Forming Cytotoxic ProteinsMembrane ProteinsProteinsHydrocarbonsOrganic Chemicals

Study Officials

  • Steven Reynolds, MD

    Fraser Health Authority

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Critical care Physician

Study Record Dates

First Submitted

October 5, 2009

First Posted

October 6, 2009

Study Start

November 1, 2009

Primary Completion

January 1, 2011

Study Completion

January 1, 2011

Last Updated

May 29, 2015

Record last verified: 2015-05

Locations

CA(1)