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CompletedNCT07593417EASY HANDSUpdated May 18, 2026

Easy Hands: Impact of a 3-Step Versus WHO 6-Step Hand Hygiene Technique on Healthcare-Associated Infections in Intensive Care and Hospitalization Units.

An interventional study of 3-Step Hand Hygiene Technique and WHO 6-Step Hand Hygiene Technique in Healthcare-Associated Infections (HAIs) and Nosocomial Infection, sponsored by Fundación Clínica Shaio. Completed at 1 site in Colombia. Per ClinicalTrials.gov, last updated 2026-05-18.

Sponsored by Fundación Clínica Shaio · Not applicable, Interventional, and Prevention

From the registry’s dates

  • Registered 7 months after the study started (first participant enrolled Sep 2025, registered Apr 2026).
Phase
Not applicable
Study type
Interventional
Enrollment
1,027
Allocation
Randomized
Sex
All
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Study summary

Healthcare-associated infections (HAIs) remain a major cause of morbidity, mortality, and healthcare costs worldwide. Hand hygiene is the cornerstone of infection prevention; however, adherence to the full WHO 6-step hand hygiene technique may be limited in routine clinical practice due to time constraints and workflow barriers. Simplified hand hygiene approaches may improve compliance while preserving clinical effectiveness.

The Easy Hands study is a pragmatic cluster randomized cross-over trial designed to compare a simplified 3-step hand hygiene technique with the standard WHO 6-step technique in clinical care units. Hospital services were randomized to one of two sequences of intervention and crossed over after the first study period. The primary objective is to evaluate whether the simplified 3-step technique is associated with differences in time to first healthcare-associated infection among hospitalized patients.

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Conditions studied

  • Healthcare-Associated Infections (HAIs)
  • Nosocomial Infection

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Keywords

  • Hand hygiene
  • Healthcare-associated infection
  • Nosocomial infection
  • Cluster randomized trial
  • Cross-over trial
  • Infection prevention
  • Patient safety
  • Intensive Care Units
  • Hospitalization
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In context

Cross Infection

239 studies on the registry are indexed under Cross Infection; 48 are open to participants now.

This study's enrollment of 1,027 is above the median of 210 across 142 interventional studies indexed under Cross Infection.

Browse Cross Infection studies →

Lead sponsor

Fundación Clínica Shaio is the lead sponsor of 2 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Admission to a participating cluster during an active intervention period.
  • Adult or pediatric hospitalized patient.
  • Availability of admission and discharge dates.
  • Eligibility for institutional infection surveillance.

Exclusion criteria

Exclusion Criteria:

  • Admission to Emergency Department or Operating Rooms.
  • HAI present at baseline (t0).
  • HAI occurring during the first two hospital days.
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Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
1,027 participants (actual)

Study arms

  • Experimental
    3-Step Hand Hygiene Technique

    Simplified 3-step hand hygiene protocol implemented in assigned clusters during the intervention period

    Behavioral: 3-Step Hand Hygiene Technique

  • Active comparator
    WHO 6-Step Hand Hygiene Technique

    Standard WHO 6-step hand hygiene protocol implemented in assigned clusters during the comparator period.

    Behavioral: WHO 6-Step Hand Hygiene Technique

Interventions

  • Behavioral3-Step Hand Hygiene Technique

    Simplified 3-step hand hygiene protocol implemented in assigned clusters during the intervention period.

  • BehavioralWHO 6-Step Hand Hygiene Technique

    Standard WHO 6-step hand hygiene protocol implemented in assigned clusters during the comparator period.

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What researchers measure

Primary outcomes

  1. Time to First Healthcare-Associated Infection

    Time from hospital admission to first documented healthcare-associated infection according to institutional surveillance criteria.

    Time frame: During hospitalization, up to 30 days

Secondary outcomes

  1. Incidence Density of Healthcare-Associated Infections

    Cases per 1,000 patient-days.

    Time frame: During hospitalization, up to 30 days

  2. Cumulative Incidence of Healthcare-Associated Infections

    Proportion of patients developing at least one HAI during follow-up.

    Time frame: During hospitalization, up to 30 days

  3. Hand Hygiene Compliance

    Percentage adherence to the assigned hand hygiene technique measured through direct observational audits using institutional hand hygiene monitoring procedures.

    Time frame: During hospitalization, up to 30 days

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Study locations

1 site
  • Fundación Clínica Shaio
    Bogotá, Bogota D.C. 110121, Colombia
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References and documents

Study documents

  • Protocol and statistical analysis plan · May 8, 2026

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No — There is no current plan to make individual participant data available outside the study team.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 18, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07593417
Lead sponsor
Fundación Clínica Shaio
Responsible party
Sponsor
First posted
May 18, 2026
Start date
Sep 1, 2025
Primary completion
Oct 31, 2025
Completion
Oct 31, 2025
Last update
May 18, 2026

Study contacts

Julia Alejandra Ortiz Aroca, M.Sc
principal investigator · Fundación Clínica Shaio

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2026. You cannot join it, but the record below documents what was studied.

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