Bacterial Infection Clinical Trial
Official title:
Comparison of Amukin Versus Biseptine Use for Dressing Application of Epicutaneocavous Catheters for Nosocomial Infection Prevention
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.
Status | Completed |
Enrollment | 453 |
Est. completion date | October 2008 |
Est. primary completion date | September 2008 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | N/A to 3 Months |
Eligibility |
Inclusion Criteria: - All infants admitted to the Neonatal Intensive Care Unit - Epicutaneocavous catheter insertion indication Exclusion Criteria: - Epicutaneocavous catheter not inserted within the Unit |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
France | Maternite Regionale Universitaire | Nancy |
Lead Sponsor | Collaborator |
---|---|
Maternite Regionale Universitaire |
France,
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Efficacy on skin colonization of two commercially available antiseptics | 2 weeks | No | |
Secondary | In case of nosocomial infection, relationship with skin bacteria | 2 weeks | No |
Status | Clinical Trial | Phase | |
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