Condition category
Surgery
Date applied
29/09/2006
Date assigned
29/09/2006
Last edited
28/04/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Mrs PM Kleidon

ORCID ID

Contact details

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

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

http://www.dh.gov.uk/Home/fs/en

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

Publication citations

Additional files

Editorial Notes