Antiseptic Use and Dressing Application

Maternite Regionale Universitaire

Status and phase: Completed; Phase 4

Conditions: Skin Colonization; Bacterial Infection; Catheterization

Treatments: Procedure: disinfection efficacy using Amukin; Procedure: disinfection efficacy using Biseptine

Study type: Interventional

Funder types: Other

Identifiers

NCT00389558

MRAP190406

Details and patient eligibility

About

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.

Full 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.

Enrollment: 453 patients

Sex: All

Ages: Under 3 months old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• Epicutaneocavous catheter not inserted within the Unit

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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453 participants in 2 patient groups

2

Active Comparator group

Description:

Biseptine

Treatment:

Procedure: disinfection efficacy using Biseptine

1

Active Comparator group

Description:

Amukin

Treatment:

Procedure: disinfection efficacy using Amukin