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Alternative Doffing Strategies to Prevent Healthcare Worker Self-Contamination When Using Personal Protective Equipment (PPE)

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ClinicalTrials.gov Identifier: NCT03192553
Recruitment Status : Completed
First Posted : June 20, 2017
Last Update Posted : March 6, 2018
Sponsor:
Information provided by (Responsible Party):
Virginia Commonwealth University

Brief Summary:
Alternative doffing strategies may help prevent self-contamination of staff members when using PPE. The study aims to determine which among the suggested methods in the literature that have been proposed as alternatives to the traditional CDC recommended doffing protocol, would be most beneficial to reduce healthcare worker self-contamination.

Condition or disease Intervention/treatment Phase
Personal Protective Equipment Behavioral: Double Gloving Procedure Behavioral: Intensified Hand Hygiene Procedure Behavioral: One Step Procedure Behavioral: CDC Procedure Not Applicable

Detailed Description:
A randomized controlled trial of doffing procedures will be conducted by healthcare worker volunteers who participate in direct patient care. However, doffing simulations will be conducted outside of patient care areas and will not involve patients. Staff participants PPE techniques will be evaluated in the controlled environment of the simulation center of the Unique Pathogens Unit. The comparison groups will be the Centers for Disease Control (CDC) procedure with the addition of a second layer of gloves (double gloving procedure), the CDC procedure with additional hand hygiene performed on gloves at key steps (intensified hand hygiene procedure), and the one-step roll off of gown and gloves (one-step procedure), with the CDC procedure as the control. Participants will be assigned to a doffing protocol chronologically starting with the double glove and ending with the control until 100 volunteers have participated. Additional PPE such as masks and goggles will be removed as part of each of the four protocols. Healthcare workers will receive a demonstration of the donning/doffing from the study coordinator, and perform a practice donn/doff prior to the observed simulation. Only one volunteer with participate in each simulation session. Glogerm (TM) will be applied to PPE in a thin stripe and smoothed to evenly with gloved hands to cover arms, trunk, and gown hem. S. epidermidis will be applied using colonies diluted in solution and spread over gloves, arms, trunk, hem with a swab.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 51 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Participants will be assigned to a doffing protocol chronologically starting with the double glove and ending with the control until 100 volunteers have participated. Only one volunteer with participate in each simulation session.
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Alternative Doffing Strategies to Prevent Healthcare Worker Self-Contamination When Using Personal Protective Equipment (PPE)
Actual Study Start Date : July 1, 2017
Actual Primary Completion Date : December 29, 2017
Actual Study Completion Date : December 31, 2017

Arm Intervention/treatment
Experimental: Double Gloving Procedure
Participants will doff PPE using a double gloving procedure after coating with Glogerm fluorescent dye +/- staphylococcus epidermidis
Behavioral: Double Gloving Procedure
Participants will doff PPE using a double gloving procedure after coating with Glogerm fluorescent dye +/- staphylococcus epidermidis

Experimental: Intensified Hand Hygiene Procedure
Participants will doff PPE using an intensified hand hygiene procedure after coating with Glogerm fluorescent dye +/- staphylococcus epidermidis
Behavioral: Intensified Hand Hygiene Procedure
Participants will doff PPE using an intensified hand hygiene procedure after coating with Glogerm fluorescent dye +/- staphylococcus epidermidis

Experimental: One-Step Procedure
Participants will doff PPE using a one-step procedure after coating with Glogerm fluorescent dye +/- staphylococcus epidermidis
Behavioral: One Step Procedure
Participants will doff PPE using a one-step procedure after coating with Glogerm fluorescent dye +/- staphylococcus epidermidis

CDC Procedure (Control)
Participants will doff PPE following the CDC procedure after coating with Glogerm fluorescent dye +/- staphylococcus epidermidis
Behavioral: CDC Procedure
Participants will doff PPE using a CDC recommended procedure after coating with Glogerm fluorescent dye +/- staphylococcus epidermidis




Primary Outcome Measures :
  1. Self-contamination rate [ Time Frame: Assessed immediately after each post-doffing simulation - self-contamination will be documented during the simulation appointment, immediately following doffing, by visual assessment ]
    Measure of frequency of contamination by body site for each doffing procedure via visual assessment


Secondary Outcome Measures :
  1. Acceptability of doffing procedure to healthcare workers [ Time Frame: Assessed immediately after each post-doffing simulation - the questionnaire will be administered before the participant leaves the simulation appointment ]
    Aspects of acceptability such as ease, comfort, and efficacy measured by Likert Scale Staff Questionnaire (1=strongly disagree, 5=strongly agree



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Clinical Providers at VCU Medical Center, including medical degree holding trainees who are medical housestaff Adults > or =18 years of age

Exclusion Criteria:

students pregnant or breastfeeding healthcare workers non-clinical providers children/teens <18 years of age open skin lesions or dermatitis presence of prosthetic materials such as prosthetic joints, heart valves


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): NCT03192553


Locations
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United States, Virginia
Virginia Commonwealth University
Richmond, Virginia, United States, 23298
Sponsors and Collaborators
Virginia Commonwealth University
Investigators
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Principal Investigator: Michelle Doll, MD Virginia Commonwealth University

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Responsible Party: Virginia Commonwealth University
ClinicalTrials.gov Identifier: NCT03192553     History of Changes
Other Study ID Numbers: HM20009234
First Posted: June 20, 2017    Key Record Dates
Last Update Posted: March 6, 2018
Last Verified: March 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Virginia Commonwealth University:
donning
doffing
self-contamination
healthcare workers