Effect of Chlorhexidine Skin Cleansing on Skin Flora

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

210 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-03-31

Study Completion Date

2005-03-31

Brief Summary

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Given the potential of skin cleansing with chlorhexidine as a safe, feasible, and cost-effective intervention for reducing neonatal death in developing country settings, this study follows a trial already underway in Nepal to test the impact of a single cleansing of the skin with baby wipes cotaining chlorahexidine.

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Detailed Description

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This study is designed to test the impact of a single cleansing of the skin with 0.25% or 4.0% Chlorhexidine wipes on qualitative and quantitative skin flora and skin condition in newborn infants. The study takes place in the Special Care Nursery at Dhaka Shishu Hospital in Dhaka, Bangladesh.

Conditions

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Skin Diseases, Infectious

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Interventions

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Chlorhexidine

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Infant admitted to Special Care Nursery at Dhaka Shishu Hospital less than 48 hours chronological age
* parental consent must be obtained

Exclusion Criteria

* infants being admitted for major surgical procedure which is attended by high rate of infectious complications
* sepsis
* clinically-evident skin infection
* generalized skin disease
* structural defect of the skin involving greater than 5% of the body surface
* with a major congenital anomaly
* with a known immunodeficiency

Maximum Eligible Age

48 Hours

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes