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Randomized Control Trial to Study the Efficacy of the Surgical Mask Versus the N95 Respirator to Prevent Influenza

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00756574
Recruitment Status : Completed
First Posted : September 22, 2008
Results First Posted : August 21, 2009
Last Update Posted : October 29, 2018
Health Canada
Information provided by (Responsible Party):
McMaster University

Brief Summary:
The goal of this study is to compare the efficacy of the surgical mask to the N95 respirator in protecting nurses from influenza in the hospital setting. The investigators propose a non-inferiority randomized controlled trial whereby nurses are randomized to either a surgical mask or an N95 respirator when caring for patients with febrile respiratory illness during the influenza season. The hypothesis is that the surgical mask offers similar protection against influenza to that of the N95. The specific objective of the study is to assess whether the rates of influenza (laboratory-confirmed by PCR and HAI assay), as well as secondary outcomes (influenza-like illness, work-related absenteeism, physician visits for respiratory illness, and lower respiratory infection), are similar among nurses using a surgical mask compared to those using an N95 respirator.

Condition or disease Intervention/treatment Phase
Influenza Device: Surgical mask Device: N95 mask Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 447 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: A Randomized Control Trial of Surgical Masks vs N95 Respirators to Prevent Influenza in Health Care Workers
Study Start Date : October 2008
Actual Primary Completion Date : April 2009
Actual Study Completion Date : May 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu Flu Shot

Arm Intervention/treatment
Active Comparator: 1. Surgical
surgical mask
Device: Surgical mask
Surgical mask worn for patients with febrile respiratory illness

Active Comparator: 2. N95 Respirator
N95 respirator
Device: N95 mask
N95 mask worn for patients with febrile respiratory illness

Primary Outcome Measures :
  1. Laboratory-confirmed Influenza Infection [ Time Frame: one year ]
    Laboratory confirmed influenza

Secondary Outcome Measures :
  1. Physician Visits for Respiratory Illness [ Time Frame: one year ]
    visit to primary care MD

  2. Influenza-like Illness [ Time Frame: Over entire study period ]
    Cough and fever

  3. Absenteeism [ Time Frame: over study period ]
    Absent from work because of flu-like illness

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Nurses who work in emergency departments and medical units
  • Nurses expected to work full time (defined as > 37 hours per week)

Exclusion Criteria:

  • Nurses who were not fit tested
  • Nurses who could not pass a fit test

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00756574

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Canada, Ontario
Hamilton Health Science
Hamilton, Ontario, Canada
Sponsors and Collaborators
McMaster University
Health Canada
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Principal Investigator: Mark Loeb, MD, MSc Hamilton Health Sciences - McMaster University
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: McMaster University Identifier: NCT00756574    
Other Study ID Numbers: 6273-15-2008
First Posted: September 22, 2008    Key Record Dates
Results First Posted: August 21, 2009
Last Update Posted: October 29, 2018
Last Verified: October 2018
Keywords provided by McMaster University:
Additional relevant MeSH terms:
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Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases