Antiseptic Use and Dressing Application
Comparison of Amukin Versus Biseptine Use for Dressing Application of Epicutaneocavous Catheters for Nosocomial Infection Prevention
1 other identifier
interventional
453
1 country
1
Brief Summary
The purposes of the study are:
- 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Sep 2006
Typical duration for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2006
CompletedFirst Submitted
Initial submission to the registry
October 17, 2006
CompletedFirst Posted
Study publicly available on registry
October 19, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2008
CompletedSeptember 21, 2009
September 1, 2009
2 years
October 17, 2006
September 18, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Efficacy on skin colonization of two commercially available antiseptics
2 weeks
Secondary Outcomes (1)
In case of nosocomial infection, relationship with skin bacteria
2 weeks
Study Arms (2)
2
ACTIVE COMPARATORBiseptine
1
ACTIVE COMPARATORAmukin
Interventions
Detersion and antiseptic application when changing catheter dressing
Detersion and antiseptic application when changing catheter dressing
Eligibility Criteria
You may qualify if:
- All infants admitted to the Neonatal Intensive Care Unit
- Epicutaneocavous catheter insertion indication
You may not qualify if:
- Epicutaneocavous catheter not inserted within the Unit
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Maternite Regionale Universitaire
Nancy, 54042, France
Related Publications (1)
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.
PMID: 11519913BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Jean-Michel HASCOET, MD
University of NANCY, France
- PRINCIPAL INVESTIGATOR
Monique LUX, Pharmacist
Maternite Regionale Universitaire
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
October 17, 2006
First Posted
October 19, 2006
Study Start
September 1, 2006
Primary Completion
September 1, 2008
Study Completion
October 1, 2008
Last Updated
September 21, 2009
Record last verified: 2009-09