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CompletedNCT00198679Updated Apr 20, 2018

Effect of Chlorhexidine Skin Cleansing on Skin Flora

A Phase 4 interventional study of Chlorhexidine in Skin Diseases, Infectious, sponsored by Johns Hopkins Bloomberg School of Public Health. Completed at 1 site in Bangladesh. Open to participants aged Up to 48 Hours, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-04-20.

Sponsored by Johns Hopkins Bloomberg School of Public Health · Phase 4, Interventional, and Prevention

Phase
Phase 4
Study type
Interventional
Enrollment
210
Allocation
Randomized
Ages
Up to 48 Hours
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Skin Diseases, Infectious

Keywords

  • skin cleansing
  • Bangladesh
  • Skin Flora
  • Newborn
  • infectious disease
  • chlorhexidine
03

In context

Skin Diseases, Infectious

88 studies on the registry are indexed under Skin Diseases, Infectious; 4 are open to participants now.

This study's enrollment of 210 is above the median of 161 across 76 interventional studies indexed under Skin Diseases, Infectious.

Browse Skin Diseases, Infectious studies →

Lead sponsor

Johns Hopkins Bloomberg School of Public Health is the lead sponsor of 369 studies on the registry; 41 are open to participants now.

Of its 5 completed or terminated interventional studies of FDA-regulated products, 3 (60%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Up to 48 Hours
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Phase
Phase 4
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
210 participants

Interventions

06

What researchers measure

Primary outcomes

  1. 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.

07

Study locations

1 site
  • Dhaka Shishu Hospital
    Dhaka, Bangladesh
08

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Mar 2004, a primary completion of Mar 2005 and a completion of Mar 2005. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 12, 2005
First posted
Sep 20, 2005
Start
Mar 2004
Primary completionActual
Mar 2005
CompletionActual
Mar 2005
Last update
Apr 20, 2018
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 20, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00198679
First posted
Sep 20, 2005
Start date
Mar 2004
Primary completion
Mar 2005
Completion
Mar 2005
Last update
Apr 20, 2018

Study contacts

Gary Darmstadt, MD
principal investigator · Johns Hopkins Bloomberg School of Public Health
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2006. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drug tested here: Chlorhexidine

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