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NCT00198679 Clinical Trial

Effect of Chlorhexidine Skin Cleansing on Skin Flora

Skin Diseases, Infectious Clinical Trial

Official title:
Effect of Chlorhexidine Skin Cleansing on Skin Flora of Newborn Infants in Bangladesh

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00198679
Other study ID # H.22.03.10.07.A2
Secondary ID
Status Completed
Phase Phase 4
First received September 12, 2005
Last updated April 18, 2018
Start date March 2004
Est. completion date March 2005

Study information
Verified date May 2006
Source Johns Hopkins Bloomberg School of Public Health
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 210
Est. completion date March 2005
Est. primary completion date March 2005
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A to 48 Hours
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Chlorhexidine

Locations
Country Name City State
Bangladesh Dhaka Shishu Hospital Dhaka

Sponsors (1)
Lead Sponsor Collaborator
Johns Hopkins Bloomberg School of Public Health

Country where clinical trial is conducted

Bangladesh, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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.
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