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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01571778
Other study ID # HP-00051378
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date April 2012
Est. completion date June 2012

Study information

Verified date March 2022
Source University of Maryland, Baltimore
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 230
Est. completion date June 2012
Est. primary completion date June 2012
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
United States University of Maryland Medical Center Baltimore Maryland

Sponsors (1)

Lead Sponsor Collaborator
University of Maryland, Baltimore

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Difference in Total Aerobic Colony Counts 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 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).
Secondary Pathogen Identification Gloves will be sampled from both groups after donning and evaluation for important hospital pathogens will be performed 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).
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