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. 2021 Jan 20;2021(1):CD013326. doi: 10.1002/14651858.CD013326.pub2

Webster 1991.

Study characteristics
Methods Controlled before and after trial
Participants 109 nursing staff and all 1916 neonates in intensive care and special care nurseries
Inclusion criteria
  • Setting: neonatal unit at the Royal Women's Hospital

  • Country: Australia

  • Health status: neonates in intensive care and special care nurseries

  • Numbers: treatment (896); control (1023) 

  • Age (mean ± SD)

    • Treatment: not reported

    • Control: not reported

  • Sex (M/F)

    • Treatment (M/F): not reported

    • Control (M/F): not reported


Exclusion criteria: not reported
Interventions Treatment group: 4% w/v chlorhexidine gluconate (Hibiciens)
Control group: 1% w/v triclosan (Novaderm) (head‐to‐head comparison)
Outcomes
  • incidence of methicillin‐resistant Staphylococcus aureus (MRSA) infection of neonates

  • Condition of nurses' skin (presence or absence of skin effects – dryness, redness, soreness, chaffed, peeling, cracked, or bleeding hands) 

Notes
  • "All babies negative for MRSA in our SCBU have a nose and umbilical swabs taken weekly for MRSA carriage. 4 weekly MRSA colonization rate is calculated by dividing the number of positive and previously positive babies by the total number of babies in the nursery (we assume that a baby remains positive for MRSA even if subsequent swabs are negative). The weekly MRSA rate was used as a crude marker to measure the effects of various hand‐wash products on the prevalence of MRSA"

  • In addition, information from the neonatal database was examined for nosocomial septicaemia, meningitis, viral infections, and necrotising enterocolitis ‐ the only infections known to be recorded reliably

  • "The questionnaire, piloted in earlier evaluations of hand wash products, was divided into three parts. The first part, an eight‐item scale, graded the severity of skin damage. Each day subjects recorded if their hands were ‘problem free’ (scored as 0); ‘dry/rough’, ‘red’, or ‘sore’ (each scored as 1); ‘chaffed’, ‘peeling’, or ‘cracked’ (each scored as 2); or ‘bleeding’"

  • The tool used assessed higher scores as better than lower scores

Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) High risk This is a controlled before and after clinical trial
(Quote: ‘Hibiclens’ was replaced by ‘Novaderm’ at each liquid soap dispenser in ICN whilst the use of ‘Hibiclens’ continued in SCN"
Allocation concealment (selection bias) High risk Not described. Probably not done
"Hand‐washing with ‘Novaderm’ was the only change to routine practice"
Blinding of participants and personnel (performance bias)
All outcomes High risk Not described. Probably not done
Blinding of outcome assessment (detection bias)
All outcomes High risk Not described. Probably not done
Incomplete outcome data (attrition bias)
All outcomes Unclear risk No information
Selective reporting (reporting bias) Unclear risk No information
Other bias High risk We suspect for publication bias. The study author published data from the study in 3 publications

ALC: alcohol.

CFU: colony‐forming unit.

CFU‐C: colony‐forming unit count.

CHG: chlorhexidine gluconate.

MRSA: methicillin‐resistant Staphylococcus aureus.

NICU: neonatal intensive care unit.

RCT: randomised controlled trial.

SCBU: special baby care unit.

SD: standard deviation.