Investigation in rates of bacterial contamination of tunnelled lines with and without elimination of presumed static electrical charge

ISRCTN ISRCTN22947085
DOI https://doi.org/10.1186/ISRCTN22947085
Protocol serial number N0012120116
Sponsor Department of Health (UK)
Funder Great Ormond Street Hospital for Children NHS Trust / Institute of Child Health (UK)
Submission date
12/09/2003
Registration date
12/09/2003
Last edited
16/12/2008
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Infections and Infestations
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Mr N Hall
Scientific

Surgery Unit
Institute of Child Health
30 Guilford Street
London
WC1N 1EH
United Kingdom

Phone +44 (0)20 7405 9200

Study information

Primary study designInterventional
Study designRandomised controlled trial
Secondary study designRandomised controlled trial
Scientific title
Study objectivesDoes pre-injection of the line packet with sterile saline prior to opening reduce the bacterial contamination rate?
Ethics approval(s)Not provided at time of registration
Health condition(s) or problem(s) studiedInfections and Infestations: Bacterial contamination
InterventionRandom allocation to (A) Treatment for bacterial contamination (B) Standard treatment.
Intervention typeOther
Primary outcome measure(s)

Rates of bacterial contamination of the lines before and after tunnelling

Key secondary outcome measure(s)

Long term infection rates of the line

Completion date30/04/2003

Eligibility

Participant type(s)Patient
Age groupChild
SexNot Specified
Key inclusion criteriaAll children undergoing placement of a percutaneous, tunnelled silastic venous access line in the interventional radiology suite will be eligible for inclusion.
Key exclusion criteriaNot provided at time of registration
Date of first enrolment01/11/2002
Date of final enrolment30/04/2003

Locations

Countries of recruitment

  • United Kingdom
  • England

Study participating centre

Surgery Unit
London
WC1N 1EH
United Kingdom

Results and Publications

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

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/07/2005 Yes No