Trial document




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  DRKS00000421

Trial Description

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Title

Tolerance of virucidal alcohol-based hand rubs - healthy volunteer trial

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Trial Acronym

VIRUZID

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URL of the Trial

http://nicht zutreffend

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Brief Summary in Lay Language

Uncoated viruses such as adenovirus or norovirus are a challenge for infection control strategies since these
pathogens are highly resistant to disinfectants. Hand hygiene is accepted to be an essential measure to prevent
infections caused by adeno- or norovirus. In case of an adeno- or norovirus infection within the clinical setting
it is strongly recommended to use a virucidal hand rub and to exchange conventional hand disinfectants by
virucidal ones (German recommendation by the Robert Koch-Institute; www.rki.de). Disadvantage of virucidal
hand rubs, however, might be limited skin-tolerability compared to conventional products. This in turn may
impair hand hygiene compliance. The aim of this trial is to compare the tolerability of three different virucidal
hand rubs and a reference conventional product.

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Brief Summary in Scientific Language

Some viruses such as adenovirus or norovirus are a challenge for infection control strategies since these
pathogens are highly resistant to disinfectants. Hand hygiene is accepted to be an essential measure to prevent
infections caused by adeno- or norovirus. In case of an adeno- or norovirus infection within the clinical setting
it is strongly recommended to use a hand rub that is effective against viruses (virucidal) and to exchange conventional hand disinfectants by
virucidal ones (German recommendation by the Robert Koch-Institute; www.rki.de). Disadvantage of virucidal
hand rubs, however, might be limited skin-tolerability compared to conventional products. This in turn may
impair hand hygiene reliability. The aim of this trial is to compare the tolerability of three different virucidal
hand rubs and a reference conventional product.

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Organizational Data

  •   DRKS00000421
  •   2010/06/14
  •   [---]*
  •   yes
  •   Approved
  •   92/10, Ethik-Kommission der Albert-Ludwig-Universität Freiburg
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Secondary IDs

  •   2010-018624-20 
  •   4036231 
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Health Condition or Problem studied

  •   Healthy volunteers
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Interventions/Observational Groups

  •   IMP-Nr. PR01: Softa-Man(R) acute, B. Braun Medical AG, Sempach, CH; Zul.-Nr. 61000.00.00
  •   IMP-Nr. PR02: Sterillium(R) virugard, Bode Chemie GmbH, Hamburg, Deutschland; Zul.-Nr.: 13814.00.00
  •   IMP-Nr. PR03: Manorapid(R) Synergy, Antiseptica GmbH, Deutschland; Zul.-Nr.: 57801.00.00
  •   IMP-Nr. PR04: Softa-Man(R) pure, B. Braun Medical AG, Sempach, CH; Zul.-Nr.: 60998.00.00
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Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Double or multiple blind
  •   [---]*
  •   Other
  •   Other
  •   Crossover
  •   IV
  •   [---]*
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Primary Outcome

Transepidermal water loss (TEWL) before and after each 4-day intervention phase.

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Secondary Outcome

- Moisture within Stratum corneum (corneometry) before and after each 4-day intervention phase. - Clinical assessment before and after each 4-day intervention phase. - Subjective evaluation by use of a structured questionaire after each 4-day intervention phase.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • [---]*
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Recruitment

  •   Planned
  •   2010/06/21
  •   20
  •   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

General inclusion criteria:
1. Signed informed consent of the volunteer.
2. Person aged > 18 years.
3. Person who are legally competent and able to sign.
Specific inclusion criteria:
4. Healthy volunteer (i. e. person who is not under medical care at the time of inclusion).

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Exclusion Criteria

General exclusion criteria:
1. Person who is not legally competent and able to sign or who do not understand the nature, intent and
importance of the trial
2. Person who is participating in other interventional trial
3. Person who has participated in other interventional trial within the last 30 days before the start of this trial
4. Known alcohol- or nicotine abuse in history
5. Person who is dependent or employed by the sponsor or principal investigator
For women:
6. Established or planned pregnancy, lactation
Specific exclusion criteria:
7. Dermatosis of any origin, especially:
8. Hand eczema
9. Sunburn on the hands
10. Atopic dermatitis
11. Known sensitisation or allergy against one of the ingredients of the IMPs
12. Continuous contact to detergents or disinfectants or continuous moist work (occupation as health care worker,
in gastronomy or as a cleaner).

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Addresses

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    • Universitätsklinikum Freiburg, vertreten durch den Leitenden Ärztlichen Direktor
    • Hugstetter Str. 55
    • 79106  Freiburg
    • Germany
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    • Institut für Umweltmedizin und Krankenhaushygiene Universitätsklinikum Freiburg
    • Mr.  Dr. med.  Andreas  Conrad 
    • Breisacher Str. 115b
    • 79106  Freiburg
    • Germany
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    • Institut für Umweltmedizin und Krankenhaushygiene Universitätsklinikum Freiburg
    • Mr.  Dr. med.  Andreas  Conrad 
    • Breisacher Str. 115b
    • 79106  Freiburg
    • Germany
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Sources of Monetary or Material Support

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    • B. Braun Medical AG
    • Seesatz
    • 6204  Sempach
    • Switzerland
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    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
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    • B. Braun-Stiftung
    • Stadtwaldpark 10
    • 34212  Melsungen
    • Germany
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Status

  •   Recruiting ongoing
  •   [---]*
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Trial Publications, Results and other Documents

  • [---]*
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* This entry means the parameter is not applicable or has not been set.