Effect of Chlorhexidine Skin Cleansing on Skin Flora

Sponsor

Johns Hopkins Bloomberg School of Public Health (Other)

Overall Status

Completed

CT.gov ID

NCT00198679

Collaborator

(none)

210

Enrollment

Location

Duration (Months)

17.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Skin Diseases, Infectious	Drug: Chlorhexidine	Phase 4

Detailed Description

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 Design

Study Type:

Interventional

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

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

Study Start Date :

Mar 1, 2004

Actual Primary Completion Date :

Mar 1, 2005

Actual Study Completion Date :

Mar 1, 2005

Outcome Measures

Primary Outcome Measures

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. []

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A to 48 Hours

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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