Effect of Chlorhexidine Skin Cleansing on Skin Flora

April 18, 2018 updated by: Johns Hopkins Bloomberg School of Public Health

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment

210

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Bangladesh
      • Dhaka, Bangladesh
        • Dhaka Shishu Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 2 days (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Johns Hopkins Bloomberg School of Public Health

Investigators

  • Principal Investigator: Gary Darmstadt, MD, Johns Hopkins Bloomberg School of Public Health

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2004

Primary Completion (Actual)

March 1, 2005

Study Completion (Actual)

March 1, 2005

Study Registration Dates

First Submitted

September 12, 2005

First Submitted That Met QC Criteria

September 12, 2005

First Posted (Estimate)

September 20, 2005

Study Record Updates

Last Update Posted (Actual)

April 20, 2018

Last Update Submitted That Met QC Criteria

April 18, 2018

Last Verified

May 1, 2006

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H.22.03.10.07.A2

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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