Effect of Chlorhexidine Skin Cleansing on Skin Flora

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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Key information

Conditions

Skin Diseases, Infectious Communicable Diseases Disease Attributes Infections Pathologic Processes Pathological Conditions, Signs and Symptoms Skin Diseases Skin and Connective Tissue Diseases

Age range

Up to 48 hour

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Dhaka Shishu Hospital

Dhaka, Bangladesh

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Chlorhexidine

Drug

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.

Sponsors and collaborators

Lead sponsor

Johns Hopkins Bloomberg School of Public Health

Other

Registry information

Official study title

Effect of Chlorhexidine Skin Cleansing on Skin Flora of Newborn Infants in Bangladesh

Important dates

Study start: 2004
Primary completion: 2005
Study completion: 2005
First posted: Sep 20, 2005
Registry last updated: Apr 20, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed