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

NCT07593417 | Completed

• 1 other identifier: DIB-25-29
• Study Type: interventional
• Target: 1,027
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Healthcare-Associated Infections (HAIs); Nosocomial Infection

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Time to First Healthcare-Associated Infection

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

  During hospitalization, up to 30 days

Secondary Outcomes (3)

• Incidence Density of Healthcare-Associated Infections

  During hospitalization, up to 30 days

• Cumulative Incidence of Healthcare-Associated Infections

  During hospitalization, up to 30 days

• Hand Hygiene Compliance

  During hospitalization, up to 30 days

Study Arms (2)

3-Step Hand Hygiene Technique

EXPERIMENTAL

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

Behavioral: 3-Step Hand Hygiene Technique

WHO 6-Step Hand Hygiene Technique

ACTIVE COMPARATOR

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

Behavioral: WHO 6-Step Hand Hygiene Technique

Interventions

3-Step Hand Hygiene Technique BEHAVIORAL

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

3-Step Hand Hygiene Technique

WHO 6-Step Hand Hygiene Technique BEHAVIORAL

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

WHO 6-Step Hand Hygiene Technique

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Fundación Clínica Shaio: lead

Study Sites (1)

Fundación Clínica Shaio

Bogotá, Bogota D.C., 110121, Colombia

Location

MeSH Terms

Conditions

Cross Infection

Condition Hierarchy (Ancestors)

Infections; Iatrogenic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Julia Alejandra Ortiz Aroca, M.Sc

  Fundación Clínica Shaio

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: None (Open Label)
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The Easy Hands study was conducted in inpatient clinical units, including intensive care and hospitalization wards. Participating units (clusters) were randomly assigned to one of two intervention sequences: Sequence AB: 3-step technique followed by 6-step technique Sequence BA: 6-step technique followed by 3-step technique Each intervention period lasted according to the predefined implementation schedule, after which clusters crossed over to the alternate technique. Patients admitted to participating units during active study periods were included consecutively and followed until first HAI, discharge, death, or administrative censoring. The study uses time-to-event methods, accounting for cluster effects, crossover design, period effects, and time-varying clinical exposures. The study hypothesis is that the simplified 3-step technique does not increase the hazard of HAI compared with the WHO 6-step standard technique.

Study Record Dates

• First Submitted: April 21, 2026
• First Posted: May 18, 2026
• Study Start: September 1, 2025
• Primary Completion: October 31, 2025
• Study Completion: October 31, 2025
• Last Updated: May 18, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

CO (1)