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

Personal Protective Equipment Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03192553
• Other study ID #: HM20009234
• Status: Completed
• Phase: N/A
• First received: May 26, 2017
• Last updated: March 5, 2018
• Start date: July 1, 2017
• Est. completion date: December 31, 2017

Study information

• Verified date: March 2018
• Source: Virginia Commonwealth University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 51
• Est. completion date: December 31, 2017
• Est. primary completion date: December 29, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Personal Protective Equipment

Intervention

Behavioral:
• Double Gloving Procedure
Participants will doff PPE using a double gloving procedure after coating with Glogerm fluorescent dye +/- staphylococcus epidermidis
• Intensified Hand Hygiene Procedure
Participants will doff PPE using an intensified hand hygiene procedure after coating with Glogerm fluorescent dye +/- staphylococcus epidermidis
• One Step Procedure
Participants will doff PPE using a one-step procedure after coating with Glogerm fluorescent dye +/- staphylococcus epidermidis
• CDC Procedure
Participants will doff PPE using a CDC recommended procedure after coating with Glogerm fluorescent dye +/- staphylococcus epidermidis

Locations

Country	Name	City	State
United States	Virginia Commonwealth University	Richmond	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
Virginia Commonwealth University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Self-contamination rate	Measure of frequency of contamination by body site for each doffing procedure via visual assessment	Assessed immediately after each post-doffing simulation - self-contamination will be documented during the simulation appointment, immediately following doffing, by visual assessment
Secondary	Acceptability of doffing procedure to healthcare workers	Aspects of acceptability such as ease, comfort, and efficacy measured by Likert Scale Staff Questionnaire (1=strongly disagree, 5=strongly agree	Assessed immediately after each post-doffing simulation - the questionnaire will be administered before the participant leaves the simulation appointment