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Sponsored by: |
Maternite Regionale Universitaire |
Information provided by: | Maternite Regionale Universitaire |
ClinicalTrials.gov Identifier: | NCT00389558 |
The purposes of the study are:
Condition | Intervention | Phase |
Skin Colonization Catheterization Bacterial Infection |
Procedure: disinfection efficacy using Amukin Procedure: disinfection efficacy using Biseptine |
Phase IV |
MedlinePlus related topics: | Bacterial Infections |
ChemIDplus related topics: | Amikacin sulfate Amikacin |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study |
Official Title: | Comparison of Amukin Versus Biseptine Use for Dressing Application of Epicutaneocavous Catheters for Nosocomial Infection Prevention |
Estimated Enrollment: | 372 |
Study Start Date: | September 2006 |
Estimated Study Completion Date: | October 2008 |
Estimated Primary Completion Date: | September 2008 (Final data collection date for primary outcome measure) |
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.
Ages Eligible for Study: | up to 3 Months |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Jean-Michel HASCOET, MD | +33 383 344 377 | jm.hascoet@maternite.chu-nancy.fr |
Contact: Marie-Christine BUCHWEILLER, RN | +33 383 344 331 | mc.buchweiller@maternite.chu-nancy.fr |
France | |||||
Maternite Regionale Universitaire | Recruiting | ||||
Nancy, France, 54042 |
Maternite Regionale Universitaire |
Study Director: | Jean-Michel HASCOET, MD | University of NANCY, France |
Principal Investigator: | Monique LUX, Pharmacist | Maternite Regionale Universitaire |
(home page of the hospital) 
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Responsible Party: | Maternite Regionale Universitaire ( Prof JM HASCOET ) |
Study ID Numbers: | MRAP190406 |
First Received: | October 17, 2006 |
Last Updated: | May 20, 2008 |
ClinicalTrials.gov Identifier: | NCT00389558 |
Health Authority: | France: Afssaps - French Health Products Safety Agency |
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