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

April 16, 2019 updated by: Gregor Seliger, Martin-Luther-Universität Halle-Wittenberg

Reducing Visitors- and Personnel-associated Infection Risk by Special Agitation Incl. Voice Prompts for Hand Disinfection on Perinatal Care Stations

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

300

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • Sachsen-Anhalt
      • Halle (Saale), Sachsen-Anhalt, Germany, 06120
        • Maternity Clinic/Perinatal Treatment Center, university hospital, Martin-Luther-Universität Halle-Wittenberg

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

7 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • Insufficient language skills

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: voice prompts
Agitation (education, reminders and optimising materials) plus voice prompts
Behavioral: voice prompts
voice prompts on disinfectant dispenser
Behavioral: agitation
Education, reminders and optimising materials
Other: no voice prompts
only Agitation (education, reminders and optimising materials); no voice prompts
Behavioral: agitation
Education, reminders and optimising materials

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total consumption of disinfectants per visitor
Time Frame: 9 months
Total consumption of disinfectants per visitor (electronically counted)
9 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Prevalence of highly positive Impact tests (swab tests)
Time Frame: 9 months
Prevalence of highly positive Impact tests (swab tests)
9 months
Total consumption of disinfectants (only children) per visitor
Time Frame: 9 months
Total consumption of disinfectants (only children) per visitor
9 months
Infection rate of typical maternal, fetal and newborn infections
Time Frame: 9 months
Infection rate of typical maternal, fetal and newborn infections
9 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Martin-Luther-Universität Halle-Wittenberg

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2016

Primary Completion (Actual)

December 1, 2017

Study Completion (Actual)

April 1, 2019

Study Registration Dates

First Submitted

January 17, 2017

First Submitted That Met QC Criteria

January 23, 2017

First Posted (Estimate)

January 26, 2017

Study Record Updates

Last Update Posted (Actual)

April 17, 2019

Last Update Submitted That Met QC Criteria

April 16, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Hygienic voice

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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