Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0012175964
Study information
Scientific title
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
Acronym
Study hypothesis
To determine if one skin antiseptic is superior to others in prevention of insertion related central venous device infection.
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Prevention
Patient information sheet
Condition
Surgery
Intervention
10% povidone-iodine with alcohol vs 0.5%chlorhexidine with 70% alcohol
Intervention type
Drug
Phase
Not Applicable
Drug names
0% povidone-iodine with alcohol, and 0.5% chlorhexidine with 70% alcohol
Primary outcome measures
Not provided at time of registration
Secondary outcome measures
Not provided at time of registration
Overall trial start date
31/01/2006
Overall trial end date
30/01/2008
Reason abandoned
Eligibility
Participant inclusion criteria
Children requiring insertion of a central venous access device
Participant type
Patient
Age group
Child
Gender
Both
Target number of participants
500
Participant exclusion criteria
Previous allergy to either skin preparations
Recruitment start date
31/01/2006
Recruitment end date
30/01/2008
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Great Ormond Street Hospital
London
WC1N 3JH
United Kingdom
Sponsor information
Organisation
Record Provided by the NHSTCT Register - 2006 Update - Department of Health
Sponsor details
The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
Great Ormond Street Hospital for Children NHS Trust / Institute of Child Health (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary