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Effect of Chlorhexidine Skin Cleansing on Skin Flora

Phase 4
Completed
Conditions
Skin Diseases, Infectious
Registration Number
NCT00198679
Lead Sponsor
Johns Hopkins Bloomberg School of Public Health
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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
210
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

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Primary Outcome Measures
NameTimeMethod
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
NameTimeMethod

Trial Locations

Locations (1)

Dhaka Shishu Hospital

🇧🇩

Dhaka, Bangladesh

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