--- title: SIMPLIFY the Hand Hygiene Procedure - Three Steps Versus Six Steps for Performing Hand Hygiene (SIMPLIFY Study) nct_id: NCT04187040 overall_status: NOT_YET_RECRUITING phase: NA sponsor: University Hospital, Basel, Switzerland study_type: INTERVENTIONAL primary_condition: Hand Hygiene canonical_url: "https://parkinsonspathways.com/agent/trials/NCT04187040.md" clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT04187040" ct_last_update_post_date: 2025-01-10 last_seen_at: "2026-05-12T06:02:45.385Z" source: ClinicalTrials.gov (mirrored, no enrichment) --- # SIMPLIFY the Hand Hygiene Procedure - Three Steps Versus Six Steps for Performing Hand Hygiene (SIMPLIFY Study) **Official Title:** SIMPLIFY the Hand Hygiene Procedure - Three Steps Versus Six Steps for Performing Hand Hygiene - an International Multicenter Cluster Randomized Trial (SIMPLIFY Study) **NCT ID:** [NCT04187040](https://clinicaltrials.gov/study/NCT04187040) ## Key Facts - **Status:** NOT_YET_RECRUITING - **Phase:** NA - **Study Type:** INTERVENTIONAL - **Target Enrollment:** 40 - **Lead Sponsor:** University Hospital, Basel, Switzerland - **Conditions:** Hand Hygiene - **Start Date:** 2025-12 - **Completion Date:** 2026-12 - **CT.gov Last Update:** 2025-01-10 ## 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. ## Eligibility - **Sex:** ALL - **Healthy Volunteers:** Yes ``` Inclusion Criteria: Health Care Workers (HCW) working at the randomized wards during the pre-defined timeframe Exclusion Criteria: Individuals, who are no HCWs ``` ## Arms - **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. - **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. ## 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 - **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 ## Primary Outcomes - **Compliance with hand hygiene indications** _(time frame: Up to one year)_ — 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 - **Compliance with the assigned hand hygiene technique** _(time frame: Up to one year)_ — 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. ## Secondary Outcomes - **Compliance with performance of the two steps for applying hand rub to the thumbs and the fingertips** _(time frame: Up to one year)_ - **Duration of the hand hygiene action** _(time frame: Up to one year)_ ## Recent Field Changes (last 30 days) - `status.overallStatus` — added _(2026-05-12)_ - `status.primaryCompletionDate` — added _(2026-05-12)_ - `status.completionDate` — added _(2026-05-12)_ - `status.lastUpdatePostDate` — added _(2026-05-12)_ - `design.phases` — added _(2026-05-12)_ - `design.enrollmentCount` — added _(2026-05-12)_ - `eligibility.criteria` — added _(2026-05-12)_ - `eligibility.sex` — added _(2026-05-12)_ - `outcomes.primary` — added _(2026-05-12)_ - `outcomes.secondary` — added _(2026-05-12)_ - `armsInterventions.arms` — added _(2026-05-12)_ - `armsInterventions.interventions` — added _(2026-05-12)_ - `sponsor.lead` — added _(2026-05-12)_ - `results.hasResults` — added _(2026-05-12)_ --- *Canonical: https://parkinsonspathways.com/agent/trials/NCT04187040.md* *Source data (authoritative): https://clinicaltrials.gov/study/NCT04187040* *This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*