Phase 4
N=112
Evaluation of Two Hand Hygiene Products in ICUs
Hand Hygiene Effectiveness
Bottom Line
View on ClinicalTrials.gov: NCT02258412 ↗Enrolled (actual)
112
Serious AEs
0.0%
Results posted
May 2017
Primary outcome: Primary: Bacterial Colony Forming Units Present on Hand Prints After Time Spent in Common Areas — 2.17; 1.81 log(10) transformed CFU
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- hand antiseptic with CHG and alcohol (Drug); Alcohol hand sanitizer foam (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Solventum US LLC
- Primary completion
- Jan 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Bacterial Colony Forming Units Present on Hand Prints After Time Spent in Common Areas |
2.17; 1.81 | — |
Summary
This study will evaluate the immediate antimicrobial efficacy and persistence of two hand hygiene products on ICU Health Care Worker's skin flora by measuring bacterial organisms on hands using the hand print method. It is hypothesized that the product containing Chlorhexidine gluconate will provide more persistence than the alcohol product, resulting in less bacterial growth on the hand print plates. In addition, environmental monitoring for cleanliness will be captured from high touch surfaces in ICU patient rooms and common areas using Rodac plates and adenosine triphosphate tests.
Eligibility Criteria
Inclusion Criteria
- HCW willing to participate in the study
- HCW willing to use non-Triclosan soap when soap is necessary throughout the study
- HCW who will don gloves prior to ICU patient room entry
Exclusion Criteria
- Use of any CHG -containing products ( liquid hand soap, Sage wipes) on the ICU 72 hours prior to study initiation and throughout study
- HCW with patient bandage or other dressing on palm(s)
- Known sensitivity or allergy to CHG or alcohols in hand hygiene products
- Known sensitivity or allergy to the following components: Lecithin, Polysorbate 80,Trypticase Soy Agar, sodium bisulfate, sodium thioglycollate, sodium thiosulfate
- History of skin allergies
Data sourced from ClinicalTrials.gov (NCT02258412). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.