Antiseptic Use and Dressing Application
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.
Description
Epicutaneocavous catheter is a significant risk factor for nosocomial infection in newborn infants. These infections have been related to local bacterial colonisation. Therefore thorough disinfection should lower the risk of nosocomial infection. However, the local efficacy of antiseptic use has not yet been clearly evaluated in this situation.
Study Design
Allocation: Randomized, Control: Active Control, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
Conditions
Skin Colonization
Intervention
disinfection efficacy using Biseptine, disinfection efficacy using Amukin
Location
Maternite Regionale Universitaire
Nancy
France
54042
Status
Completed
Source
Maternite Regionale Universitaire
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT00389558
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
Disinfection
Rendering pathogens harmless through the use of heat, antiseptics, antibacterial agents, etc.
Therapeutic Equivalency
The relative equivalency in the efficacy of different modes of treatment of a disease, most often used to compare the efficacy of different pharmaceuticals to treat a given disease.
Dichloroacetate
An acetic acid derivative that is a metabolite of TRICHLOROETHYLENE and is formed during chlorine disinfection of drinking water. It has effects on GLUCOSE metabolism, lowers LACTATE, and activates the PYRUVATE DEHYDROGENASE COMPLEX.
Buspirone
An anxiolytic agent and a serotonin receptor agonist belonging to the azaspirodecanedione class of compounds. Its structure is unrelated to those of the benzodiazepines, but it has an efficacy comparable to DIAZEPAM.
Product Surveillance, Postmarketing
Surveillance of drugs, devices, appliances, etc., for efficacy or adverse effects, after they have been released for general sale.
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