Contamination During Removal of Two Different Personal Protective Systems
1 other identifier
interventional
50
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jan 2005
Shorter than P25 for not_applicable
1 active site
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
Study Start
First participant enrolled
January 1, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2005
CompletedFirst Submitted
Initial submission to the registry
September 6, 2005
CompletedFirst Posted
Study publicly available on registry
September 8, 2005
CompletedSeptember 8, 2005
September 1, 2005
September 6, 2005
September 6, 2005
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
The primary endpoint of this study is the presence of any detected
base clothing layer, skin, or hair contamination.
Secondary Outcomes (2)
The secondary endpoints: 1) contamination episodes of any layer, and 2) protective
system donning and removal procedure violations
Interventions
Eligibility Criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Kingston General Hospital
Kingston, Ontario, K7L 2V7, Canada
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jorge E. Zamora, MD
Queen's University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Purpose
- ECT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
September 6, 2005
First Posted
September 8, 2005
Study Start
January 1, 2005
Study Completion
May 1, 2005
Last Updated
September 8, 2005
Record last verified: 2005-09