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

Amortegui 1978.

Study characteristics
Methods Cross‐over clinical trial
Participants Numbers of nurses and neonates were unclear ( "A total of 1,806 cultures were evaluated. The study was single‐blind to nurses. Nurses involved fluctuated between four and six in
each nursery, according to the baby census"
Inclusion criteria

  • Setting: 2 well‐baby nurseries were selected, at Magee Women's Hospital, Pittsburgh, Pennsylvania, USA, between October 1974 and March 1975

  • Country: USA

  • Health status:

    • "Two well‐baby nurseries"

  • Numbers: treatment (unclear); control (unclear) [Numbers: treatment (unclear); control (unclear)] ["The number of nurses involved fluctuated between four and six in each nursery, according to the baby census"]

  • 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

  • Betadine surgical scrub


Control group

  • Prepodyne scrub
Outcomes

  • Nursing personnel hand colonisation

  • Infants umbilical colonisation
Notes A total of 1806 cultures were evaluated. The study was single‐blind to the nurses
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) High risk No randomisation is applied
Quote: "both products were used alternatively for hand wash in each of the two study nurseries in an effort to minimise nursery variation"
Allocation concealment (selection bias) High risk Not reported, probably not done
Blinding of participants and personnel (performance bias)
All outcomes Unclear risk It is unclear what study authors meant by (quote) "The study was single blinded to the nurses"
Blinding of outcome assessment (detection bias)
All outcomes Unclear risk Quote: "the cultures were interpreted by one of the technologists in the microbiology laboratory. This person was also involved in culture collection"
It was not stated whether this person was blinded to the intervention
Incomplete outcome data (attrition bias)
All outcomes Low risk There was no report of attrition
Selective reporting (reporting bias) Unclear risk We did not have access to the study protocol; it is unclear
Other bias High risk The numbers of nurses and neonates involved in the study were not clearly stated. Also the study did not report if there was a washout period before participants crossed to a new intervention group