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
Secondary identifying numbers N0012175964
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

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typePrevention
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
Pharmaceutical study type(s)
PhaseNot Applicable
Drug / device / biological / vaccine name(s)0% povidone-iodine with alcohol, and 0.5% chlorhexidine with 70% alcohol
Primary outcome measureNot provided at time of registration
Secondary outcome measuresNot provided at time of registration
Overall study start date31/01/2006
Completion date30/01/2008

Eligibility

Participant type(s)Patient
Age groupChild
SexBoth
Target number of participants500
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

  • England
  • United Kingdom

Study participating centre

Great Ormond Street Hospital
London
WC1N 3JH
United Kingdom

Sponsor information

Record Provided by the NHSTCT Register - 2006 Update - Department of Health
Government

The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Phone +44 (0)20 7307 2622
Email dhmail@doh.gsi.org.uk
Website http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Government

Great Ormond Street Hospital for Children NHS Trust / Institute of Child Health (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan