Clinical Trial: Contamination During Removal of Two Different Personal Protective Systems

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Contamination During Removal of Two Different Personal Protective Systems When Working Under Conditions Requiring Enhanced Respiratory and Contact Precautions

Brief Summary:

Highly communicable and virulent diseases, the ongoing threat of emerging infectious diseases, and the prospect of bio-terrorism have become part of the new reality for health care workers. SARS transmission has occurred despite the use of droplet, contact, and airborne precautions. Potential explanations for some of the episodes of “through-precautions” transmission include the possibility of contamination during removal of protective clothing.

The recommended protective systems (PPS) for aerosol generating procedures set out by the US Center for Disease Control and Prevention (CDC) and the Ontario Ministry of Health and Long Term Care (MOHLTC) differ.

The failure of a PPS may be associated with significant consequences in terms of the morbidity and mortality of front-line health care workers. The purpose of this study is to determine if a difference exists between the rate of self-contamination due to deficiencies in contact precautions for individuals wearing either the CDC or MOHLTC recommended PPS.

Study participants will don one of the two recommended PPS, be “contaminated” with an indicator that becomes visible under ultraviolet light, and then assessed for contamination of clothing layers and skin after removal of the PPS. They will then repeat the procedure using the other PPS.


Detailed Summary:

Background: Highly communicable and virulent diseases such as severe acute respiratory syndrome (SARS) and “avian influenza”, the ongoing threat of other emerging infectious diseases, and the prospect of bio-terrorism have become part of the new reality for health care workers (1). Recent experience with SARS has demonstrated that front-line health care professionals who perform or assist with aerosol generating procedures are at particularly increased risk of infection.

At present, no data exists addressing the question of self-contamination during the removal of personal protective systems used in a health care setting. The latest suggested donning and removal procedures have not been validated with respect to the issue of selfcontamination due to deficiencies in contact precautions.

The failure of a personal protective system or the donning and removal procedures for a personal protective system may be associated with significant consequences in terms of the morbidity and mortality of front-line health care workers. It is imperative that the rate of self-contamination for these two personal protective systems be assessed.

The purpose of this study is to determine if a difference exists between the rate of self-contamination due to deficiencies in contact precautions for individuals wearing either Personal Protective Equipment (PPE) or the Powered Air Purifying Respirator (PAPR).

This will be a prospective, randomized, controlled, crossover study.

Institutional Ethics Committee approval will be obtained for this study. Fifty participants will be required for the study. Participants will be recruited from the Department of Anesthesiology attending and resident st
Sponsor: Queen's University

Current Primary Outcome:

  • The primary endpoint of this study is the presence of any detected
  • base clothing layer, skin, or hair contamination.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • The secondary endpoints: 1) contamination episodes of any layer, and 2) protective
  • system donning and removal procedure violations


Original Secondary Outcome: Same as current

Information By: Queen's University

Dates:
Date Received: September 6, 2005
Date Started: January 2005
Date Completion: May 2005
Last Updated: September 6, 2005
Last Verified: September 2005