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Gown and Glove Use to Prevent the Spread of Infection in VA Community Living Centers

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development
ClinicalTrials.gov Identifier:
NCT01350479
First received: May 6, 2011
Last updated: January 24, 2017
Last verified: November 2016
Results First Received: November 16, 2016  
Study Type: Observational
Study Design: Observational Model: Cohort;   Time Perspective: Prospective
Condition: Methicillin-Resistant Staphylococcus Aureus

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Three participants withdrew from the study prior to cultures being obtained and were not assigned to a study group.

Reporting Groups
  Description
MRSA Colonized Residents colonized with MRSA by culture at study admission
Not MRSA Colonized Residents not colonized with MRSA by culture at study admission

Participant Flow:   Overall Study
    MRSA Colonized   Not MRSA Colonized
STARTED   94   106 
COMPLETED   94   106 
NOT COMPLETED   0   0 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
MRSA Colonized Residents colonized with MRSA by culture at study admission
Not MRSA Colonized Residents not colonized with MRSA by culture at study admission
Total Total of all reporting groups

Baseline Measures
   MRSA Colonized   Not MRSA Colonized   Total 
Overall Participants Analyzed 
[Units: Participants]
 94   106   200 
Age 
[Units: Years]
Mean (Standard Deviation)
 73  (13)   70  (13)   71  (13) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      2   2.1%      6   5.7%      8   4.0% 
Male      92  97.9%      100  94.3%      192  96.0% 
Region of Enrollment 
[Units: Participants]
     
United States   94   106   200 


  Outcome Measures

1.  Primary:   MRSA Transmission   [ Time Frame: Will be measured during 6-25 episodes of care interactions scheduled over the 30 days following resident enrollment ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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