SIMPLIFY the Hand Hygiene Procedure - Three Steps Versus Six Steps for Performing Hand Hygiene (SIMPLIFY Study)

NCT04187040 | Not Yet Recruiting

• 1 other identifier: 2019-01071;me19Tschudinsutter2
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief Summary

Hand hygiene is one of the most important measures to prevent healthcare associated infections. A hand hygiene technique consisting of three steps may be superior to the 6-step technique outlined by the World Health Organization (WHO) in terms of compliance with both indications and technique. Therefore, the aim of this study is to compare compliance with hand hygiene indications and technique between a 3-step and the 6-step technique for applying hand rub in an international multicenter cluster randomized trial.

Conditions

Hand Hygiene

Keywords

WHO-guideline on hand hygiene in healthcare; 3-step hand hygiene technique; 6-step hand hygiene technique

Outcome Measures

Primary Outcomes (2)

• Compliance with hand hygiene indications

  Compliance with the five hand hygiene indications defined by the WHO: * before touching a patient * before clean/aseptic procedures * after body fluid exposure risk * after touching a patient * after touching patient surroundings

  Up to one year

• Compliance with the assigned hand hygiene technique

  Compliance with the assigned technique, defined as performance of the proposed three steps in the intervention group and of all six steps in the control group.

  Up to one year

Secondary Outcomes (2)

• Compliance with performance of the two steps for applying hand rub to the thumbs and the fingertips

  Up to one year

• Duration of the hand hygiene action

  Up to one year

Study Arms (2)

3-step hand hygiene technique

ACTIVE COMPARATOR

Wards assigned to this study arm will receive instructions, educational materials and tutorials about the 3-step hand hygiene technique.

Procedure: Study intervention: 3-step hand hygiene technique

6-step hand hygiene technique

ACTIVE COMPARATOR

Wards assigned to this study arm will receive instructions, educational materials and tutorials about the 6-step hand hygiene technique.

Procedure: Control intervention: 6-step hand hygiene technique

Interventions

Study intervention: 3-step hand hygiene technique PROCEDURE

3-step hand hygiene technique: 1. Covering all surfaces of the hands (based on own judgement) 2. Rotational rubbing of fingertips in the palm of the alternate hand 3. Rotational rubbing of both thumbs

3-step hand hygiene technique

Control intervention: 6-step hand hygiene technique PROCEDURE

6-step hand hygiene technique (according to the WHO Guidelines on Hand Hygiene in Health Care, First Global Patient Safety Challenge): 1. Rubbing hands palm to palm 2. Palm to palm with fingers interlaced 3. Right palm over left dorsum with interlaced fingers and vice versa 4. Back of fingers to opposing palms with fingers interlocked 5. Rotational rubbing of left thumb clasped in right palm and vice versa 6. Rotational rubbing backwards and forwards with clasped fingers of right hand in left palm and vice versa

6-step hand hygiene technique

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Health Care Workers (HCW) working at the randomized wards during the pre-defined timeframe

You may not qualify if:

• Individuals, who are no HCWs

Sponsors & Collaborators

• University Hospital, Basel, Switzerland: lead

Study Officials

• Sarah Tschudin Sutter, Prof.Dr.med.

  University Hospital, Basel, Switzerland

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sarah Tschudin Sutter, Prof.Dr.med.

CONTACT

+41 61 328 68 10; sarah.tschudin@usb.ch

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: All participating wards will be randomly assigned with a 1:1 allocation to either the intervention (3-step hand hygiene technique) or the control group (6-step hand hygiene technique). Randomization will be stratified by participating institution for balanced allocation. Within each stratum, block randomization will be applied to assign wards to the two study groups. Blocking will be used to ensure close balance of the number of wards assigned to each group at any time during the study. Stratified randomization will be performed to ensure balance of the two groups within each institution.

Study Record Dates

• First Submitted: November 12, 2019
• First Posted: December 5, 2019
• Study Start: December 1, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: January 10, 2025

Record last verified: 2025-01