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Effect of Chlorhexidine Skin Cleansing on Skin Flora

Johns Hopkins Bloomberg School of Public Health logo

Johns Hopkins Bloomberg School of Public Health

Status and phase

Completed
Phase 4

Conditions

Skin Diseases, Infectious

Treatments

Drug: Chlorhexidine

Study type

Interventional

Funder types

Other

Identifiers

NCT00198679
H.22.03.10.07.A2

Details and patient eligibility

About

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.

Full 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.

Sex

All

Ages

Under 48 hours old

Volunteers

Accepts 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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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