Hand Hygiene Before Non-sterile Glove Use

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Kerri A Thom, University of Maryland
ClinicalTrials.gov Identifier:
NCT01571778
First received: March 29, 2012
Last updated: July 2, 2012
Last verified: May 2012
  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 Blind (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 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). ] [ Designated as safety issue: No ]
    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). ] [ Designated as safety issue: No ]
    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
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.


  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01571778

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

No publications provided

Responsible Party: Kerri A Thom, Assistant Professor, University of Maryland
ClinicalTrials.gov Identifier: NCT01571778     History of Changes
Other Study ID Numbers: HP-00051378
Study First Received: March 29, 2012
Last Updated: July 2, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of Maryland:
Hand Hygiene
Non-sterile Glove Use

ClinicalTrials.gov processed this record on October 20, 2014