- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01571778
Hand Hygiene Before Non-sterile Glove Use
The Utility of Hand Hygiene Before Non-sterile Glove Use
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Maryland
-
Baltimore, Maryland, United States, 21201
- University of Maryland Medical Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: RANDOMIZED
- Interventional Model: SINGLE_GROUP
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
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
|
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
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).
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- HP-00051378
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Hand Hygiene
-
Otto-Friedrich-University BambergUniversity of TurkuEnrolling by invitation
-
Swiss Tropical & Public Health InstituteUniversity of Applied Sciences and Arts Northwestern Switzerland; Terre des...CompletedHand Hygiene Effectiveness | Hand Hygiene BehaviorBurkina Faso, Mali
-
The Hong Kong Polytechnic UniversityRecruiting
-
Sundara ReddyMicrodermis CorporationCompleted
-
University Hospital, Basel, SwitzerlandCompleted
-
London School of Hygiene and Tropical MedicineAcademic Centre for Dentistry in Amsterdam; Deutsche Gesellshaft fur Internationale...CompletedHand HygienePhilippines
-
Medline IndustriesNorthShore University HealthSystemCompleted
-
Istanbul Sultanbeyli State HospitalCompleted
-
Molnlycke Health Care ABBioScience Laboratories, Inc.Completed
-
Glasgow Caledonian UniversityTan Tock Seng Hospital; University of East Anglia; University of Strathclyde; NHS...CompletedHand HygieneUnited Kingdom
Clinical Trials on Hand Hygiene before Donning Non-sterile Gloves
-
University of Maryland, BaltimoreAgency for Healthcare Research and Quality (AHRQ)Completed
-
Central Medicare Sdn. Bhd.Consumer Product Testing Company, Inc.Completed
-
VA Office of Research and DevelopmentRecruiting
-
YTY Industry (Manjung) Sdn BhdCompleted