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. 2016 Jul 13;2016(7):CD010140. doi: 10.1002/14651858.CD010140.pub2

Tuominen 1981.

Methods Single‐centre RCT (Finland)
Study period:not reported.
Setting: ICU
Participants Adult inpatients admitted to ICU who required a CVC. No exclusion criteria stated
Number of participants:136
Number of catheters; 136 (124 analysed)
Age: not reported
Sex: not reported
Interventions Skin antisepsis applied prior to CVC insertion and regularly thereafter.
  1. Intervention A: chlorhexidine 0.05% added to the sterile gauze and applied at the CVC insertion site twice daily

  2. Intervention B: sterile gauze application without chlorhexidine

Outcomes
  • Septicaemia

  • Catheter colonisation

  • Adverse effects

  • Number of patients on antibiotics during the in‐dwelling time of the catheters


Outcomes assessed at various points during in‐patient stay.
Notes No adverse effects were recorded in either group, so we do not include the data in our analysis.
Funding source: not stated.
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk 'Patients and methods': The patients were "randomly allocated to one of two groups".
Allocation concealment (selection bias) Unclear risk Not adequately described
Blinding of participants and personnel (performance bias) 
 All outcomes High risk Not stated in the paper, but blinding appears unlikely as the trial involved a comparison between the application of chlorhexidine‐soaked gauze versus a dry sterile gauze.
Blinding of outcome assessment (detection bias) 
 All outcomes Unclear risk Blinding of microbiological outcome assessor not reported
Incomplete outcome data (attrition bias) 
 All outcomes Unclear risk The authors did not provide information on the initial number of patients and catheters recruited or the eventual number analysed.
Selective reporting (reporting bias) Low risk The outcomes were not defined in the 'Methods'. However, authors reported all major outcomes, including septicaemia, catheter colonisation and adverse effects, in sufficient detail.
Other bias Low risk None identified