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OpenTrials
Completed

NCT Number: NCT07593417

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

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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Key information

Conditions

Healthcare-Associated Infections (HAIs) Cross Infection Disease Attributes Iatrogenic Disease Infections Nosocomial Infection Pathologic Processes Pathological Conditions, Signs and Symptoms

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Fundación Clínica Shaio

Bogotá, Bogota D.C., 110121, Colombia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

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

Treatment and study plan

3-Step Hand Hygiene Technique

Behavioral

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

WHO 6-Step Hand Hygiene Technique

Behavioral

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

Primary outcomes

  1. Time to First Healthcare-Associated Infection

    Time frame: During hospitalization, up to 30 days

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

Secondary outcomes

  1. Incidence Density of Healthcare-Associated Infections

    Time frame: During hospitalization, up to 30 days

    Cases per 1,000 patient-days.

  2. Cumulative Incidence of Healthcare-Associated Infections

    Time frame: During hospitalization, up to 30 days

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

  3. Hand Hygiene Compliance

    Time frame: During hospitalization, up to 30 days

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

Sponsors and collaborators

Lead sponsor

Fundación Clínica Shaio

Other

Registry information

Official study title

Easy Hands: A Cluster Randomized Cross-Over Trial Evaluating a Simplified 3-Step Hand Hygiene Technique Versus the WHO 6-Step Technique on the Incidence of Healthcare-Associated Infections.

Acronym: EASY HANDS

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
May 18, 2026
Registry last updated
May 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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