Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
453 participants
INTERVENTIONAL
2006-09-30
2008-10-31
Brief Summary
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1. To compare the local efficacy (skin colonization) of 2 commercialized antiseptics used for the disinfection of the dressing application for an epicutaneocavous catheter (EPI).
2. To evaluate whether the bacteria responsible for nosocomial infection is comparable to the flora diagnosed at the EPI site.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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2
Biseptine
disinfection efficacy using Biseptine
Detersion and antiseptic application when changing catheter dressing
1
Amukin
disinfection efficacy using Amukin
Detersion and antiseptic application when changing catheter dressing
Interventions
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disinfection efficacy using Biseptine
Detersion and antiseptic application when changing catheter dressing
disinfection efficacy using Amukin
Detersion and antiseptic application when changing catheter dressing
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Epicutaneocavous catheter insertion indication
Exclusion Criteria
3 Months
ALL
No
Sponsors
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Maternite Regionale Universitaire
OTHER
Responsible Party
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Maternite Regionale Universitaire
Principal Investigators
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Jean-Michel HASCOET, MD
Role: STUDY_DIRECTOR
University of NANCY, France
Monique LUX, Pharmacist
Role: PRINCIPAL_INVESTIGATOR
Maternite Regionale Universitaire
Locations
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Maternite Regionale Universitaire
Nancy, , France
Countries
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References
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Mahieu LM, De Dooy JJ, De Muynck AO, Van Melckebeke G, Ieven MM, Van Reempts PJ. Microbiology and risk factors for catheter exit-site and -hub colonization in neonatal intensive care unit patients. Infect Control Hosp Epidemiol. 2001 Jun;22(6):357-62. doi: 10.1086/501913.
Other Identifiers
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MRAP190406
Identifier Type: -
Identifier Source: org_study_id
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