NCT03192553

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
51

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 26, 2017

Completed
25 days until next milestone

First Posted

Study publicly available on registry

June 20, 2017

Completed
11 days until next milestone

Study Start

First participant enrolled

July 1, 2017

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 29, 2017

Completed
2 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2017

Completed
Last Updated

March 6, 2018

Status Verified

March 1, 2018

Enrollment Period

6 months

First QC Date

May 26, 2017

Last Update Submit

March 5, 2018

Conditions

Personal Protective Equipment

Keywords

donningdoffingself-contaminationhealthcare workers

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Acceptability of doffing procedure to healthcare workers

    Assessed immediately after each post-doffing simulation - the questionnaire will be administered before the participant leaves the simulation appointment

Study Arms (4)

Double Gloving Procedure

EXPERIMENTAL

Participants will doff PPE using a double gloving procedure after coating with Glogerm fluorescent dye +/- staphylococcus epidermidis

Behavioral: Double Gloving Procedure

Intensified Hand Hygiene Procedure

EXPERIMENTAL

Participants will doff PPE using an intensified hand hygiene procedure after coating with Glogerm fluorescent dye +/- staphylococcus epidermidis

Behavioral: Intensified Hand Hygiene Procedure

One-Step Procedure

EXPERIMENTAL

Participants will doff PPE using a one-step procedure after coating with Glogerm fluorescent dye +/- staphylococcus epidermidis

Behavioral: One Step Procedure

CDC Procedure (Control)

OTHER

Participants will doff PPE following the CDC procedure after coating with Glogerm fluorescent dye +/- staphylococcus epidermidis

Behavioral: CDC Procedure

Interventions

Double Gloving ProcedureBEHAVIORAL

Participants will doff PPE using a double gloving procedure after coating with Glogerm fluorescent dye +/- staphylococcus epidermidis

Double Gloving Procedure
Intensified Hand Hygiene ProcedureBEHAVIORAL

Participants will doff PPE using an intensified hand hygiene procedure after coating with Glogerm fluorescent dye +/- staphylococcus epidermidis

Intensified Hand Hygiene Procedure
One Step ProcedureBEHAVIORAL

Participants will doff PPE using a one-step procedure after coating with Glogerm fluorescent dye +/- staphylococcus epidermidis

One-Step Procedure
CDC ProcedureBEHAVIORAL

Participants will doff PPE using a CDC recommended procedure after coating with Glogerm fluorescent dye +/- staphylococcus epidermidis

CDC Procedure (Control)

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

Location

Study Officials

  • Michelle Doll, MD

    Virginia Commonwealth University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 26, 2017

First Posted

June 20, 2017

Study Start

July 1, 2017

Primary Completion

December 29, 2017

Study Completion

December 31, 2017

Last Updated

March 6, 2018

Record last verified: 2018-03

Locations

US(1)