Evaluation of Two Hand Hygiene Products in ICUs

NCT02258412 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 51

Last updated 2024-10-23

Study results available
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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.

Conditions

  • Hand Hygiene Effectiveness

Interventions

DRUG

hand antiseptic with CHG and alcohol

HCWs will be randomized to use one product on one day and the other product on another day at least 3 days apart. Each product will be applied using 1 pump from its dispenser and rubbed over the hands until dry. Gloves will be worn while the HCW is in the patient room. Upon exit from the room, HCW will washoout with that same product. One imprint will be made of the non-dominant hand onto media containing neutralizers. That hand will be gloved with a white cotton glove. The HCW will work in the common areas with timing recorded. Upon leaving the common area, the dominant ungloved hand will be imprinted onto a fresh media plate containing neutralizers.

DRUG

Alcohol hand sanitizer foam

Alcohol foam hand sanitizer applied with 1 pump into hands, spread over hands up to the wrist and rubbed until dry. Foam will be applied twice approximately 15-30 minutes apart on one day

Sponsors & Collaborators

  • 3M

    collaborator INDUSTRY
  • Solventum US LLC

    lead INDUSTRY

Principal Investigators

  • Abhishek Deshpande, MD, PhD · The Cleveland Clinic

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-10-31
Primary Completion
2015-01-31
Completion
2015-02-28
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02258412 on ClinicalTrials.gov