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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

Tracking Information
First Submitted Date  ICMJE May 26, 2017
First Posted Date  ICMJE June 20, 2017
Last Update Posted Date March 6, 2018
Actual Study Start Date  ICMJE July 1, 2017
Actual Primary Completion Date December 29, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 16, 2017)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03192553 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 16, 2017)
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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Alternative Doffing Strategies to Prevent Healthcare Worker Self-Contamination When Using Personal Protective Equipment (PPE)
Official Title  ICMJE Alternative Doffing Strategies to Prevent Healthcare Worker Self-Contamination When Using Personal Protective Equipment (PPE)
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.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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
Condition  ICMJE Personal Protective Equipment
Intervention  ICMJE
  • Behavioral: Double Gloving Procedure
    Participants will doff PPE using a double gloving 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
  • Behavioral: One Step Procedure
    Participants will doff PPE using a one-step 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
Study Arms  ICMJE
  • Experimental: Double Gloving Procedure
    Participants will doff PPE using a double gloving procedure after coating with Glogerm fluorescent dye +/- staphylococcus epidermidis
    Intervention: Behavioral: Double Gloving Procedure
  • Experimental: Intensified Hand Hygiene Procedure
    Participants will doff PPE using an intensified hand hygiene procedure after coating with Glogerm fluorescent dye +/- staphylococcus epidermidis
    Intervention: Behavioral: Intensified Hand Hygiene Procedure
  • Experimental: One-Step Procedure
    Participants will doff PPE using a one-step procedure after coating with Glogerm fluorescent dye +/- staphylococcus epidermidis
    Intervention: Behavioral: One Step Procedure
  • CDC Procedure (Control)
    Participants will doff PPE following the CDC procedure after coating with Glogerm fluorescent dye +/- staphylococcus epidermidis
    Intervention: Behavioral: CDC Procedure
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 5, 2018)
51
Original Estimated Enrollment  ICMJE
 (submitted: June 16, 2017)
100
Actual Study Completion Date  ICMJE December 31, 2017
Actual Primary Completion Date December 29, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03192553
Other Study ID Numbers  ICMJE HM20009234
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Virginia Commonwealth University
Study Sponsor  ICMJE Virginia Commonwealth University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Michelle Doll, MD Virginia Commonwealth University
PRS Account Virginia Commonwealth University
Verification Date March 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP