NCT00150475

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

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2005

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

Study Start

First participant enrolled

January 1, 2005

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2005

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

September 6, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 8, 2005

Completed
Last Updated

September 8, 2005

Status Verified

September 1, 2005

First QC Date

September 6, 2005

Last Update Submit

September 6, 2005

Conditions

Keywords

Severe Acute Respiratory Syndrome

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

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kingston General Hospital

Kingston, Ontario, K7L 2V7, Canada

Location

MeSH Terms

Conditions

Severe Acute Respiratory Syndrome

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsVirus DiseasesRespiratory Tract Diseases

Study Officials

  • Jorge E. Zamora, MD

    Queen's University

    PRINCIPAL INVESTIGATOR

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

Locations