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Antiseptic Use and Dressing Application

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00389558
Recruitment Status : Completed
First Posted : October 19, 2006
Last Update Posted : September 21, 2009
Information provided by:
Maternite Regionale Universitaire

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.

Condition or disease Intervention/treatment Phase
Skin Colonization Catheterization Bacterial Infection Procedure: disinfection efficacy using Biseptine Procedure: disinfection efficacy using Amukin Phase 4

Detailed 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 453 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Comparison of Amukin Versus Biseptine Use for Dressing Application of Epicutaneocavous Catheters for Nosocomial Infection Prevention
Study Start Date : September 2006
Actual Primary Completion Date : September 2008
Actual Study Completion Date : October 2008

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: 2
Procedure: disinfection efficacy using Biseptine
Detersion and antiseptic application when changing catheter dressing
Other Name: Biseptine

Active Comparator: 1
Procedure: disinfection efficacy using Amukin
Detersion and antiseptic application when changing catheter dressing
Other Name: Amukin

Primary Outcome Measures :
  1. Efficacy on skin colonization of two commercially available antiseptics [ Time Frame: 2 weeks ]

Secondary Outcome Measures :
  1. In case of nosocomial infection, relationship with skin bacteria [ Time Frame: 2 weeks ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   up to 3 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • All infants admitted to the Neonatal Intensive Care Unit
  • Epicutaneocavous catheter insertion indication

Exclusion Criteria:

  • Epicutaneocavous catheter not inserted within the Unit

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00389558

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Maternite Regionale Universitaire
Nancy, France, 54042
Sponsors and Collaborators
Maternite Regionale Universitaire
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Study Director: Jean-Michel HASCOET, MD University of NANCY, France
Principal Investigator: Monique LUX, Pharmacist Maternite Regionale Universitaire
Additional Information:
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Responsible Party: Prof JM HASCOET, Maternite Regionale Universitaire Identifier: NCT00389558    
Other Study ID Numbers: MRAP190406
First Posted: October 19, 2006    Key Record Dates
Last Update Posted: September 21, 2009
Last Verified: September 2009
Keywords provided by Maternite Regionale Universitaire:
Skin colonization
Epicutaneocavous catheter dressing
Additional relevant MeSH terms:
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Bacterial Infections
Anti-Bacterial Agents
Anti-Infective Agents