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Reducing Visitors- and Personnel-associated Infection Risk on Perinatal Care Station

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ClinicalTrials.gov Identifier: NCT03032887
Recruitment Status : Completed
First Posted : January 26, 2017
Last Update Posted : April 17, 2019
Sponsor:
Information provided by (Responsible Party):
Gregor Seliger, Martin-Luther-Universität Halle-Wittenberg

Tracking Information
First Submitted Date  ICMJE January 17, 2017
First Posted Date  ICMJE January 26, 2017
Last Update Posted Date April 17, 2019
Actual Study Start Date  ICMJE March 2016
Actual Primary Completion Date December 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 26, 2017)
Total consumption of disinfectants per visitor [ Time Frame: 9 months ]
Total consumption of disinfectants per visitor (electronically counted)
Original Primary Outcome Measures  ICMJE
 (submitted: January 23, 2017)
Total consumption of disinfectants per visitor [ Time Frame: 3 months ]
Total consumption of disinfectants per visitor (electronically counted)
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 26, 2017)
  • Prevalence of highly positive Impact tests (swab tests) [ Time Frame: 9 months ]
    Prevalence of highly positive Impact tests (swab tests)
  • Total consumption of disinfectants (only children) per visitor [ Time Frame: 9 months ]
    Total consumption of disinfectants (only children) per visitor
  • Infection rate of typical maternal, fetal and newborn infections [ Time Frame: 9 months ]
    Infection rate of typical maternal, fetal and newborn infections
Original Secondary Outcome Measures  ICMJE
 (submitted: January 23, 2017)
  • Prevalence of highly positive Impact tests (swab tests) [ Time Frame: 3 months ]
    Prevalence of highly positive Impact tests (swab tests)
  • Total consumption of disinfectants (only children) per visitor [ Time Frame: 3 months ]
    Total consumption of disinfectants (only children) per visitor
  • Infection rate of typical maternal, fetal and newborn infections [ Time Frame: 3 months ]
    Infection rate of typical maternal, fetal and newborn infections
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Reducing Visitors- and Personnel-associated Infection Risk on Perinatal Care Station
Official Title  ICMJE Reducing Visitors- and Personnel-associated Infection Risk by Special Agitation Incl. Voice Prompts for Hand Disinfection on Perinatal Care Stations
Brief Summary

The rate of infectious diseases (amnioninfection syndrome (AIS), fetal inflammatory response syndrome (FIRS), early-onset neonatal sepsis (EONS)) in perinatal care / neonatology is steadily rising in Germany. The hands of the staff and visitors are the most important transmission vehicle of pathogens. Hence hand hygiene is one of the most important measures for the prevention of hospital infections. The different measures of hand hygiene serve to protect against the spread of contamination of the skin with obligate or potentially pathogenic pathogens. Since the use of antibiotics is generally only possible to a limited extent (especially in pregnant women and neonates in perinatal care centers) the primary prophylactic measures are of great importance.

While the importance of hand disinfection in the staff has been undisputed, there is no data on the rate of hand disinfection for visitors of perinatal care centers. Visitor at these stations are common non-compliant persons (especially children!). On the other hand, pregnant women and young mothers and newborn babies are "exposed" to a large number of visitors compared to other stations.

The investigators examine whether special measures (such as voice prompts) have a positive effect on the rate of performed hand disinfections or consecutively on the infection rate.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Hygiene
Intervention  ICMJE
  • Behavioral: voice prompts
    voice prompts on disinfectant dispenser
  • Behavioral: agitation
    Education, reminders and optimising materials
Study Arms  ICMJE
  • Experimental: voice prompts
    Agitation (education, reminders and optimising materials) plus voice prompts
    Interventions:
    • Behavioral: voice prompts
    • Behavioral: agitation
  • no voice prompts
    only Agitation (education, reminders and optimising materials); no voice prompts
    Intervention: Behavioral: agitation
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 23, 2017)
300
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE April 2019
Actual Primary Completion Date December 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Minimum age: 7 years
  • informed consent
  • Member of target group: Visitor or staff

Exclusion Criteria:

  • Insufficient language skills
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 7 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03032887
Other Study ID Numbers  ICMJE Hygienic voice
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Gregor Seliger, Martin-Luther-Universität Halle-Wittenberg
Study Sponsor  ICMJE Martin-Luther-Universität Halle-Wittenberg
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Martin-Luther-Universität Halle-Wittenberg
Verification Date April 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP