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Antiseptic Use and Dressing Application

This study has been completed.
Sponsor:
Information provided by:
Maternite Regionale Universitaire
ClinicalTrials.gov Identifier:
NCT00389558
First received: October 17, 2006
Last updated: September 18, 2009
Last verified: September 2009
History of Changes
  Purpose

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 Intervention Phase
Skin Colonization
Catheterization
Bacterial Infection
 Procedure: disinfection efficacy using Biseptine
Procedure: disinfection efficacy using Amukin
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Comparison of Amukin Versus Biseptine Use for Dressing Application of Epicutaneocavous Catheters for Nosocomial Infection Prevention

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Maternite Regionale Universitaire:

Primary Outcome Measures:
  • Efficacy on skin colonization of two commercially available antiseptics [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • In case of nosocomial infection, relationship with skin bacteria [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]

Enrollment: 453
Study Start Date: September 2006
Study Completion Date: October 2008
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 2
Biseptine
 Procedure: disinfection efficacy using Biseptine
Detersion and antiseptic application when changing catheter dressing
Other Name: Biseptine
Active Comparator: 1
Amukin
 Procedure: disinfection efficacy using Amukin
Detersion and antiseptic application when changing catheter dressing
Other Name: Amukin

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.

  Eligibility

Ages Eligible for Study:   up to 3 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Epicutaneocavous catheter not inserted within the Unit
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00389558

Locations
France
Maternite Regionale Universitaire
Nancy, France, 54042
Sponsors and Collaborators
Maternite Regionale Universitaire
Investigators
Study Director: Jean-Michel HASCOET, MD University of NANCY, France
Principal Investigator: Monique LUX, Pharmacist Maternite Regionale Universitaire
  More Information

Additional Information:
(home page of the hospital)  This link exits the ClinicalTrials.gov site

Publications:

Responsible Party: Prof JM HASCOET, Maternite Regionale Universitaire
ClinicalTrials.gov Identifier: NCT00389558     History of Changes
Other Study ID Numbers: MRAP190406
Study First Received: October 17, 2006
Last Updated: September 18, 2009
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Maternite Regionale Universitaire:
Skin colonization
Antiseptic
Epicutaneocavous catheter dressing
Infant

Additional relevant MeSH terms:
Bacterial Infections
Cross Infection
Infection
Amikacin
Anti-Infective Agents, Local
 Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 21, 2013