Randomised trial comparing 10% povidone-iodine with alcohol and 0.5% chlorhexidine with 70% alcohol for prevention of early infection associated with central venous catheter insertion

ISRCTN ISRCTN51113796
DOI https://doi.org/10.1186/ISRCTN51113796
Protocol serial number N0012175964
Sponsor Record Provided by the NHSTCT Register - 2006 Update - Department of Health
Funder Great Ormond Street Hospital for Children NHS Trust / Institute of Child Health (UK)
Submission date
29/09/2006
Registration date
29/09/2006
Last edited
28/04/2015
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Surgery
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Mrs PM Kleidon
Scientific

MRI 1 & 2
Great Ormond Street Hospital
Great Ormond Street
London
WC1N 3JH
United Kingdom

Study information

Primary study designInterventional
Study designRandomised controlled trial
Secondary study designRandomised controlled trial
Scientific titleRandomised trial comparing 10% povidone-iodine with alcohol and 0.5% chlorhexidine with 70% alcohol for prevention of early infection associated with central venous catheter insertion
Study objectivesTo determine if one skin antiseptic is superior to others in prevention of insertion related central venous device infection.
Ethics approval(s)Not provided at time of registration
Health condition(s) or problem(s) studiedSurgery
Intervention10% povidone-iodine with alcohol vs 0.5%chlorhexidine with 70% alcohol
Intervention typeDrug
PhaseNot Applicable
Drug / device / biological / vaccine name(s)0% povidone-iodine with alcohol, and 0.5% chlorhexidine with 70% alcohol
Primary outcome measure(s)

Not provided at time of registration

Key secondary outcome measure(s)

Not provided at time of registration

Completion date30/01/2008

Eligibility

Participant type(s)Patient
Age groupChild
SexAll
Target sample size at registration500
Key inclusion criteriaChildren requiring insertion of a central venous access device
Key exclusion criteriaPrevious allergy to either skin preparations
Date of first enrolment31/01/2006
Date of final enrolment30/01/2008

Locations

Countries of recruitment

  • United Kingdom
  • England

Study participating centre

Great Ormond Street Hospital
London
WC1N 3JH
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
IPD sharing plan