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

NCT ID: NCT04187040

Last Updated: 2025-01-10

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-12-31
• Study Completion Date: 2026-12-31

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.

Detailed Description

Hand hygiene is one of the most important measures to prevent transmission of pathogens between healthcare workers and patients, and ultimately, healthcare-associated infections. However, compliance with both hand hygiene indications and technique (outlining the steps for applying hand rub to ensure coverage of all surfaces of the hands) remains insufficient at most institutions worldwide. It was previously demonstrated that a hand hygiene technique consisting of three steps is superior to the 6-step technique outlined by the World Health Organization (WHO) in terms of compliance with both indications and technique in a single center study. Furthermore, the 3-step technique was non-inferior regarding microbiological efficacy in two experimental studies and during daily clinical practice. To further investigate the external validity and generalizability of these findings to different settings, this study compares both compliance with hand hygiene indications and technique between the 3-step and the 6-step technique for applying hand rub in an international multicenter cluster randomized trial.

Conditions

Hand Hygiene

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

3-step hand hygiene technique

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

Group Type: ACTIVE_COMPARATOR

Study intervention: 3-step hand hygiene technique

Intervention Type: 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

6-step hand hygiene technique

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

Group Type: ACTIVE_COMPARATOR

Control intervention: 6-step hand hygiene technique

Intervention Type: 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

Interventions

Study intervention: 3-step hand hygiene technique

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

Intervention Type: PROCEDURE

Control intervention: 6-step hand hygiene technique

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

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

Individuals, who are no HCWs

• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University Hospital, Basel, Switzerland

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sarah Tschudin Sutter, Prof.Dr.med.

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Basel, Switzerland

Central Contacts

Sarah Tschudin Sutter, Prof.Dr.med.

Role: CONTACT

sarah.tschudin@usb.ch

+41 61 328 68 10

Other Identifiers

2019-01071;me19Tschudinsutter2

Identifier Type: -

Identifier Source: org_study_id