Effect of Chlorhexidine Skin Cleansing on Skin Flora

Phase 4CompletedNCT00198679

Johns Hopkins Bloomberg School of Public Health210 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

210

Conditions

Skin Diseases, Infectious

Interventions

ChlorhexidineDRUG

Eligibility

Sex: ALLMax age: 48 HoursHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Dhaka Shishu Hospital

Dhaka, Bangladesh

Outcomes

Primary Outcomes

Wiping of newborn skin will be done immediatly upon enrollment in study, with follow up during hosptial stay and up to two weeks to determine skin condition and presence of any kind of skin infection.

Data from ClinicalTrials.gov

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