Trial document




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  DRKS00016615

Trial Description

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Title

Ambulatory screening and decontamination to prevent STaphylococcus AUreus complications in patients with elective surgery

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Trial Acronym

STAUfrei

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URL of the Trial

http://www.staufrei-hdh.de

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Brief Summary in Lay Language

The STAUfrei Study investigates a possibility to reduce the number of certain harmful pathogens (Staphylococcus Aureus: MRSA and MSSA) in the hospital setting. This project is supported by the federal joint committee’s innovation fund. During a hospital stay there is an elevated risk of complications due to wound infections after surgical interventions. This can result in prolonged hospital stays and increased use of antibiotics as well as additional GP visits.

The aim of the STAUfrei-Study is to prevent the introduction of S Aureus to the hospital setting. Before undergoing elective surgery, all patients will be screened by their GPs. In case of a positive results, patients will be decontaminated in the ambulatory setting. After completed surgery, patients will receive a follow-up treatment by their GP. This will include wound inspection as well as MRSA Screening and if necessary repeated decontamination.

Additional study objectives are i.a. health economic evaluation, prevention of surgical site infections and patient and provider satisfaction with the intervention.

Patients with a scheduled surgery in the Hospital in Heidenheim and aged 18 and above can take part in the study.

The study will be carried out in the district of Heidenheim. All patients with an elective surgery in the municipal hospital (Klinikum Heidenheim) are eligible for inclusion. The study will be carried out over a 3-year period, starting in April 2019.

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Brief Summary in Scientific Language

The primary aim of the STAUfrei-Study is to prevent the introduction of S Aureus (MRSA and MSSA) to the hospital setting through systematic screening and decontamination prior to hospital admission. To reach this aim we will conduct a interventional study with a controlled before and after comparison with patients scheduled for elective surgery in the municipality hospital in Heidenheim. The new treatment model will encompass a ambulatory screeing prior to hospital admission as well as a structured after care in the ambulatory setting. Primary endpoint is the reduction of MRSA and MSSA colonizations upon hosptial admission. Secondary endpoints evaluate post operative complication rates (i.e. surgical site infections) as well as number of recolonizations. In addition acceptance and satisfaction of providers (GPs and their medical team) and patients will be evaluated.
The intervetion phase will be conducted from April 2019 until March 2021.

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Do you plan to share individual participant data with other researchers?

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Description IPD sharing plan:

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Organizational Data

  •   DRKS00016615
  •   2019/04/01
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  •   yes
  •   Approved
  •   F-2018-090, Ethik-Kommission bei der Landesärztekammer Baden-Württemberg
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Secondary IDs

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Health Condition or Problem studied

  •   MRSA and MSSA colonization upon hospital admission
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Interventions/Observational Groups

  •   Patients colonized with S Aureus will be instructed by their GPs to self-administer a comprehensive set of decontamination measures over a 5 day period prior to admission:

    anitbacterial wash lotion (daily)
    nasal mupirocin ointment (3x per day)
    antiseptic mouth rinse (3x per day)
    desinfection of commonly used objects and aids as well as the environment (daily)
  •   Routine care (SOP), usually 1-2 showers with an antiseptic soap prior to surgery
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Characteristics

  •   Interventional
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  •   Non-randomized controlled trial
  •   Open (masking not used)
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  •   Other
  •   Prevention
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

Colonisation with MRSA and MSSA upon hospital admission

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Secondary Outcome

Infection rates, post-operative MRSA colonization, incremental costs (ambulatory and hospital costs), Patient satisfaction (paper based questionnaire), Acceptance by providers (GPs and their teams)

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Medical Center 
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Recruitment

  •   Actual
  •   2019/04/01
  •   13260
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

Patients scheduled for elective surgery as well as risk bearing interventions in the hospital in Heidenheim (Klinikum Heidenheim)

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Exclusion Criteria

Patients below 18 years old and emergency patients

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Addresses

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    • Der Innovationsfonds und der Innovationsausschuss beim Gemeinsamen Bundesausschuss
    • Postfach 120606
    • 10623  Berlin
    • Germany
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    • AOK Baden-Wuerttemberg
    • Ms.  Mareen  Reinhart 
    • Presselstraße 19
    • 70191  Stuttgart
    • Germany
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    • BKK Landesverband Süd
    • Mr.  Stephan  Trabert 
    • Stuttgarterstraße 105
    • 70806  Kornwestheim
    • Germany
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    • Steinbeis-Hochschule Berlin
    • Mr.  Prof. Dr. med.  Bernd  Brüggenjürgen 
    • Gürtelstraße 29A/30
    • 10247  Berlin
    • Germany
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    • Institut für Mikrobiologie und Hygiene, Universitätsklinikum Tübingen
    • Mr.  Dr.  Jan  Liese 
    • Silcherstraße 5
    • 72076  Tübingen
    • Germany
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    • Landratsam Heidenheim, Fachbereich Gesundheit
    • Mr.  Christoph  Bauer 
    • Felsentraße 36
    • 89518  Heidenheim
    • Germany
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    • Institut für Allgemeinmedizin und Interprofessionelle Versorgung (IAIV), Univeristätsklinikum Tübingen
    • Ms.  Prof. Dr. med.  Stefanie  Joos 
    • Osianderstraße 5
    • 72076  Tübingen
    • Germany
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    • Pathways Public Health GmbH
    • Ms.  Rieke  Schulz 
    • Neustädtische Kirchstraße 8
    • 10117  Berlin
    • Germany
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    • Institut für Klinische Epidemiologie und Angewandte Biometrie (IkEaB)
    • Mr.  Prof. Dr.   Peter  Martus 
    • Silcherstraße 5
    • 72076  Tübingen
    • Germany
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    • Kassenärztliche Vereinigung Baden-Württemberg (KVBW)
    • Mr.  Rüdiger  Kucher 
    • Albstadtweg 11
    • 70567  Stuttgart
    • Germany
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    • Institut für Allgemeinmedizin und Interprofessionelle Versorgung (IAIV), Universitätsklinikum Tübingen
    • Ms.  Dr. med.  Heidrun  Sturm (MPH, Ph.D.) 
    • Osianderstraße 5
    • 72076  Tübingen
    • Germany
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    • STAUfrei-Zentrale Klinikum Heidenheim
    • Ms.  Elfriede   Zeck 
    • Schloßhaustraße 100
    • 89522  Heidenheim an der Brenz
    • Germany
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Sources of Monetary or Material Support

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    • Innovationsausschuss beim Gemeinsamen Bundesausschuss
    • Postfch 120606
    • 10623  Berlin
    • Germany
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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