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Hand Hygiene Before Non-sterile Glove Use

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01571778
First Posted: April 5, 2012
Last Update Posted: December 2, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Kerri A Thom, University of Maryland
  Purpose
The importance of healthcare worker hand hygiene in decreasing bacterial transmission between patients is well documented. Healthcare workers may don non-sterile gloves in routine care of patients, particularly for those patients known or suspected to harbor epidemiologically important microorganisms. Governing bodies currently recommend performing hand hygiene prior to donning gloves and after glove removal. The importance of hand hygiene post glove removal is well shown, however few studies exist to show utility of hand hygiene prior to donning gloves. In fact, data suggests that glove use is an impediment to hand hygiene and may reduce compliance with hand washing. In light of this and the fact that no evidence exists that washing hands BEFORE glove use is important, the aim of the study is to asses the utility of routine hand hygiene prior to donning non-sterile gloves before a patient contact.

Condition Intervention
Hand Hygiene Behavioral: Hand Hygiene before Donning Non-sterile Gloves

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: The Utility of Hand Hygiene Before Non-sterile Glove Use

Resource links provided by NLM:


Further study details as provided by Kerri A Thom, University of Maryland:

Primary Outcome Measures:
  • Difference in Total Aerobic Colony Counts [ Time Frame: The total time of participation from the healthcare worker will be approximately 2-3 minutes, the time needed to perform hand hygiene and don gloves (group 1) or don gloves (group 2). ]
    The Difference in Total Aerobic Colony Counts from hands at baseline (Group 1, prior to Hand Hygiene; Group 2, prior to donning gloves) to gloves after donning


Secondary Outcome Measures:
  • Pathogen Identification [ Time Frame: The total time of participation from the healthcare worker will be approximately 2-3 minutes, the time needed to perform hand hygiene and don gloves (group 1) or don gloves (group 2). ]
    Gloves will be sampled from both groups after donning and evaluation for important hospital pathogens will be performed


Enrollment: 230
Study Start Date: April 2012
Study Completion Date: June 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Donning Gloves without Hand Hygiene
In this arm, healthcare workers will be assigned to don non-sterile gloves prior to patient contact WITHOUT first performing hand hygiene. Samples will be obtained from hands prior to donning gloves and from the gloves after donning to determine total aerobic colony counts and to identify important hospital pathogens
Behavioral: Hand Hygiene before Donning Non-sterile Gloves

In the "No Intervention" arm, healthcare workers will be assigned to first perform hand hygiene before donning non-sterile gloves prior to patient contact (usual practice). Samples will be obtained from hands prior to donning gloves and from the gloves after donning to determine total aerobic colony counts and to identify important hospital pathogens

In the Experimental arm, they will be instructed to don gloves without washing their hands as described.

No Intervention: Hand Hygiene before donning Non-Sterile Gloves
In this arm, healthcare workers will be assigned to first perform hand hygiene before donning non-sterile gloves prior to patient contact (This is usual,expected practice). Samples will be obtained from hands prior to donning gloves and from the gloves after donning to determine total aerobic colony counts and to identify important hospital pathogens

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthcare worker engaging in direct patient contact on Contact Precautions (e.g. expected glove use)
  • >= 18 years of age

Exclusion Criteria:

  • Visibly soiled hands requiring hand washing (cannot randomize)
  • Non-compliance with glove use as indicated for care of patient on Contact Precautions
  Contacts and Locations
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): NCT01571778


Locations
United States, Maryland
University of Maryland Medical Center
Baltimore, Maryland, United States, 21201
Sponsors and Collaborators
University of Maryland
  More Information

Responsible Party: Kerri A Thom, Assistant Professor, University of Maryland
ClinicalTrials.gov Identifier: NCT01571778     History of Changes
Other Study ID Numbers: HP-00051378
First Submitted: March 29, 2012
First Posted: April 5, 2012
Last Update Posted: December 2, 2015
Last Verified: November 2015

Keywords provided by Kerri A Thom, University of Maryland:
Hand Hygiene
Non-sterile Glove Use