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Evaluation of Two Hand Hygiene Products in ICUs

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ClinicalTrials.gov Identifier: NCT02258412
Recruitment Status : Completed
First Posted : October 7, 2014
Results First Posted : May 16, 2017
Last Update Posted : May 16, 2017
Sponsor:
Information provided by (Responsible Party):
3M

Brief 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.

Condition or disease Intervention/treatment Phase
Hand Hygiene Effectiveness Drug: hand antiseptic with CHG and alcohol Drug: Alcohol hand sanitizer foam Phase 4

Detailed Description:
Crossover study with 50 Health care workers using each product with a minimum of 3 days in between. Products will be applied twice as per manufacturer's instructions for a Healthcare Personnel Handwash followed by immediate hand print. Persistent hand prints will be collected after exposure to environmental contaminants in the common areas. Hand prints will also be collected from one hand of 60 patients cared for by a participating Health Care Worker and gloved hand of Health Care Worker. All media contain neutralizers to inactivate active ingredients in each product and on surfaces. Each hand print plate's area of growth will be measured for Colony Forming Units using computerized software.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 51 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Evaluation of Antimicrobial Efficacy of Two Hand Hygiene Products in ICUs Using Hand Prints
Study Start Date : October 2014
Actual Primary Completion Date : January 2015
Actual Study Completion Date : February 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: 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.
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
Other Name: Purell Instant Sanitizer Foam

Active Comparator: hand antiseptic with CHG and alcohol
Hand antiseptic is applied by dispensing 1 pump into hands, spreading over the hands up to the wrist, and rubbing until dry. Hand antiseptic will be used twice approximately 15-30 minutes apart on one day.
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.
Other Names:
  • Avagard CHG Hand Antiseptic with Moisturizers
  • Purell Advanced Instant Hand Sanitizer Foam




Primary Outcome Measures :
  1. Bacterial Colony Forming Units Present on Hand Prints After Time Spent in Common Areas [ Time Frame: On each of 2 days, Hand print plates collected from one hand immediately after product use (T0) and from other hand after time spent in MICU common areas ]
    Hand print plates will be collected from HCWs immediately after use of hand hygiene product and after time spent in common areas. Each HCW will use both products at least 3 days apart. Hand print plates from each product for each HCW will be compared.



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02258412


Locations
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United States, Ohio
Cleveland Clinic
Cleveland, Ohio, United States, 44195
Sponsors and Collaborators
3M
Investigators
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Principal Investigator: Abhishek Deshpande, MD, PhD The Cleveland Clinic

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: 3M
ClinicalTrials.gov Identifier: NCT02258412     History of Changes
Other Study ID Numbers: EM-05-013218
First Posted: October 7, 2014    Key Record Dates
Results First Posted: May 16, 2017
Last Update Posted: May 16, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by 3M:
antimicrobial
efficacy
hand
hygiene
bacteria
Additional relevant MeSH terms:
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Ethanol
Anti-Infective Agents, Local
Hand Sanitizers
Anti-Infective Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Disinfectants