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Effect of Chlorhexidine Skin Cleansing on Skin Flora

Primary Purpose

Skin Diseases, Infectious

Status
Completed
Phase
Phase 4
Locations
Bangladesh
Study Type
Interventional
Intervention
Chlorhexidine
Sponsored by
Johns Hopkins Bloomberg School of Public Health
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for Skin Diseases, Infectious focused on measuring skin cleansing, Bangladesh, Skin Flora, Newborn, infectious disease, chlorhexidine

Eligibility Criteria

undefined - 48 Hours (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Dhaka Shishu Hospital

Outcomes

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.

Secondary Outcome Measures

Full Information

First Posted
September 12, 2005
Last Updated
April 18, 2018
Sponsor
Johns Hopkins Bloomberg School of Public Health
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1. Study Identification

Unique Protocol Identification Number
NCT00198679
Brief Title
Effect of Chlorhexidine Skin Cleansing on Skin Flora
Official Title
Effect of Chlorhexidine Skin Cleansing on Skin Flora of Newborn Infants in Bangladesh
Study Type
Interventional

2. Study Status

Record Verification Date
May 2006
Overall Recruitment Status
Completed
Study Start Date
March 2004 (undefined)
Primary Completion Date
March 2005 (Actual)
Study Completion Date
March 2005 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Johns Hopkins Bloomberg School of Public Health

4. Oversight

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Skin Diseases, Infectious
Keywords
skin cleansing, Bangladesh, Skin Flora, Newborn, infectious disease, chlorhexidine

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
210 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Chlorhexidine
Primary Outcome Measure Information:
Title
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.

10. Eligibility

Sex
All
Maximum Age & Unit of Time
48 Hours
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gary Darmstadt, MD
Organizational Affiliation
Johns Hopkins Bloomberg School of Public Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dhaka Shishu Hospital
City
Dhaka
Country
Bangladesh

12. IPD Sharing Statement

Learn more about this trial

Effect of Chlorhexidine Skin Cleansing on Skin Flora

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