Skip to main content
. 2023 Jun 6;2023(6):CD013326. doi: 10.1002/14651858.CD013326.pub4

Sharma 2013.

Study characteristics
Methods Randomised cross‐over study
Participants 35 female nursing staff and all babies in NICU (actual number not reported)
Inclusion criteria
  • Setting: level III NICU of a tertiary care institute

  • Country: northern India

  • Health status: working nurses/babies in NICU

  • Number: 35 staff nurses working for 1 year or longer in the NICU and willing to comply with instructions related to hand hygiene

  • Age (mean ± SD): "25 to 48 years"

  • Sex (M/F)

    • Treatment (M/F): female nurses

    • Control (M/F): female nurses


Exclusion criteria: nurses with a history of iodine sensitivity were excluded.
Interventions Alcohol hand rub (45% 2‐propanol, 30% 1‐propanol, and 0.2% ethyl‐hexadecyl‐dimethyl‐ammonium‐ethylsulphate) vs povidone‐iodine hand scrub with 0.5% w/v available iodine vs plain (non‐antimicrobial) soap (head‐to‐head comparison)
Treatment group
  • Soap: hands were washed with a plain (i.e. non‐antimicrobial) bar soap for 15 seconds and rinsed under running tap water. Hands were dried with autoclaved hand wipes after the handwash. Bar soap was placed in a soap tray with a drainage system.


Control group
  • Alcohol: alcohol hand rub, which accounted for 45% 2‐propanol, 30% 1‐propanol, and 0.2% ethyl‐hexadecyl‐dimethyl‐ammonium‐ethylsulphate (Sterilium, Raman and Weil Pvt Ltd., Mumbai, India). 2 mL of solution was dispensed, smeared on the hands, and allowed to dry.

  • Povidone: povidone‐iodine hand scrub with 0.5% w/v available iodine (Povicidal, Cadila Pharmaceuticals Ltd., Dhokla, India). 2 mL of solution was applied, scrubbed for 15 seconds, and rinsed under running tap water. Hands were dried with autoclaved hand wipes after the procedure.

Outcomes  
  • Post‐hygiene colony‐forming unit count (CFU‐C) on nurses' hands

  • Absolute and percentage reduction in CFC‐C on nurses' hands

  • Post‐hygiene low CFU‐C (< 50 CFU‐C) on nurses' hands


 
Notes  
  • Visual Scoring of Skin Condition (VSS) scale is a 6‐point scale using stereo microscopic examination of the hands at 3 times magnification; it correlates well with other physiologic measures of skin condition.


"The scores range from 6 (normal, no observable scale or irritation) to 1 (extensive cracking of skin surface, widespread reddening or occasional bleeding)".
"In previous studies, including validation with dermatologist ratings, an interrater agreement of > 95% within a score ± 1 was consistently obtained over a large spectrum of damaged and undamaged hands of various skin types".
  • "The Hand Skin Assessment Form (HSAF) is a self‐rating scale developed in the 1980s for subjects to assess the condition of their hands".


"Subjects gave themselves a score from 1 to 7 in 4 dimensions: appearance, intactness, moisture content, and sensation. The possible range of scores is 4 to 28, with 28 indicating totally healthy skin. In previous studies, scores correlated significantly with other physiologic measures of skin damage".
  • "These 2 instruments used together (VSS and HSAF) provided both subjective and objective assessment of skin condition, minimising bias and providing an ongoing assessment of reliability".

  • "There were 14‐day neutral periods for each subject prior to each intervention. During the neutral periods, enrolled nurses received detailed instructions regarding the correct use of the hand hygiene measures. Elbow operated taps were used. To allow the natural hand flora to establish, they were asked to use only non‐antimicrobial soaps both in the NICU and at home and elsewhere during the neutral periods".


This study did not declare funding source.
 
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Quote: "The random sequences were generated online".
Randomisation was done at the end of the first neutral period.
 
Allocation concealment (selection bias) Low risk Serially numbered opaque and sealed envelopes were opened as nurses were enrolled.
Blinding of participants and personnel (performance bias)
All outcomes Low risk Participants were not blinded but outcomes were unlikely to be influenced by lack of blinding.
Blinding of outcome assessment (detection bias)
All outcomes Low risk Quote: "the microbiologist was blinded to the hand hygiene method used and the identity of the subjects".
Incomplete outcome data (attrition bias)
All outcomes Low risk There was no attrition.
Selective reporting (reporting bias) High risk Neonatal infection at baseline was reported; however, the result post‐intervention was not available for this important outcome.
Other bias Unclear risk No access to study protocol

ABHR: alcohol based hand rub
ALC: alcohol
CFU: colony‐forming unit
CFU‐C: colony‐forming unit count
CHG: chlorhexidine gluconate
F: female
HAI: Healthcare associated infection
HSAF: Hand Skin Assessment Form
IMCI: Integrated Management of Childhood Illness
IQR: Interquartile range
M: male
MRSA: methicillin‐resistant Staphylococcus aureus
NICU: neonatal intensive care unit
NNIS: National Nosocomial Infections Surveillance System
RCT: randomised controlled trial
SCBU: special baby care unit
SD: standard deviation
VHW: village health workers
vs: versus
VSS: Visual Scoring of Skin Condition
w/v: weight per volume