Trial document





This trial has been registered retrospectively.
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  DRKS00004724

Trial Description

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Title

Multinational prospective analysis of data from poison information centres on the question of corrosive eye lesions due to solid machine dishwashing products and other detergents, maintenance and cleaning products

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Trial Acronym

MAGAM II

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URL of the Trial

[---]*

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Brief Summary in Lay Language

This study is intended to answer the following questions:
Do eye exposures involving solid machine dishwashing products (powders or tabs) or other detergents or cleaning products cause severe eye damage in humans?
Answering the issue with the help of data from the European poisons centres (PCs).
There was an amendment (08.10.2013). Due to this, the number of participating countries has increased.

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Brief Summary in Scientific Language

Many exposures involving chemicals – both in households and also in the wider environs – lead to an exposure of the eyes in the handling and use of detergents, maintenance and cleaning products. There can be product-specific differences in the risk of damage to the eyes. Case data from poison information centres provide valuable information about the outcome of such cases of poisoning.
This study is intended to answer the following issue:
Do eye exposures with detergents or cleaning products – which are placed on the market for private consumers – cause severe eye damage in humans?
Answering the issue with the help of data from the poison information centres (PICs). Gaining epidemiological data on exposure and outcome based on a timely, structured (uniform) follow-up by telephone and, possibly, additional medical/ophthalmologic findings.

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Organizational Data

  •   DRKS00004724
  •   2013/04/04
  •   [---]*
  •   yes
  •   Approved
  •   14/9/12, Ethik-Kommission der Medizinischen Fakultät der Georg-August-Universität Göttingen
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Secondary IDs

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Health Condition or Problem studied

  •   H57.9 -  Disorder of eye and adnexa, unspecified
  •   T55 -  Toxic effect of soaps and detergents
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Interventions/Observational Groups

  •   All callers are contacted again 12 hours after the incident at the earliest, in order to survey them on the outcome of the case.The telephone follow-up is recorded on a standardized documentation form (CRF).
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Characteristics

  •   Non-interventional
  •   Observational study
  •   Single arm study
  •   Open (masking not used)
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  •   Uncontrolled/Single arm
  •   Other
  •   Single (group)
  •   N/A
  •   N/A
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Primary Outcome

All callers are contacted at least 12 hours after the incident in order to perform a survey on symptoms and outcome of the case. The results of telephone follow-up call is recorded on a standardized documentation form (Case Report Form, CRF).

Moderate and severe eye injuries are registered according to the poisoning severity score (PSS) (Persson et. al., J Clinical Toxicology (1998) 36:205-13)

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Secondary Outcome

All callers are contacted at least 12 hours after the incident in order to perform a survey on circumstances of exposure to detergents, maintenance and cleaning products.
The telephone follow-up call is recorded on a standardized documentation form (Case Report Form, CRF).

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Countries of Recruitment

  •   Germany
  •   Austria
  •   Czech Republic
  •   Denmark
  •   Italy
  •   Slovakia
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Locations of Recruitment

  • University Medical Center 
  • Medical Center 
  • University Medical Center 
  • Medical Center 
  • University Medical Center 
  • University Medical Center 
  • University Medical Center 
  • University Medical Center 
  • University Medical Center 
  • University Medical Center 
  • Medical Center 
  • University Medical Center 
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Recruitment

  •   Actual
  •   2013/02/01
  •   1000
  •   Multicenter trial
  •   International
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Inclusion Criteria

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

Species: human exposures only
Route: eye exposure
Age: all age and sex
Given consent
Consent for minors by persons having care and custody or legal representatives
Agents: all products of the category detergents, maintenance and cleaning products The exact allocation of products for inclusion and exclusion, respectively, is governed by the TDI agent category system (https://www.klinitox.de/142.0.html)
Causality
Follow-up: Cases with follow-up, if the observation time after exposure is longer than 12 hours. Cases without follow up.

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Exclusion Criteria

no causality

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Addresses

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    • Gesellschaft für Klinische Toxikologie (GfKT)
    • Mr.  Dr.med   Andreas  Stürer 
    • Langenbeckstr. 1
    • 55131  Mainz
    • Germany
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    • Universitätsmedizin Göttingen Giftinformationszentrum Nord (GIZ-Nord)
    • Mr.  Dr.rer nat  Herbert  Desel 
    • Robert-Koch-Str. 40
    • 37075  Göttingen
    • Germany
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    • Universitätsmedizin Göttingen Giftinformationszentrum Nord (GIZ-Nord)
    • Ms.  Elke  Färber 
    • Robert-Koch-Str. 40
    • 37075  Göttingen
    • Germany
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Sources of Monetary or Material Support

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    • Chemie Wirtschafsförderungs-GmbH (CWFG)
    • Mainzer Landstrasse 55
    • 60329  Frankfurt
    • Germany
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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