Effect of Chlorhexidine Skin Cleansing on Skin Flora
This trial is active, not recruiting.
|Condition||skin diseases, infectious|
|Sponsor||Johns Hopkins Bloomberg School of Public Health|
|Start date||March 2004|
|End date||March 2005|
|Trial size||210 participants|
|Trial identifier||NCT00198679, H.22.03.10.07.A2|
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.
|Endpoint classification||efficacy study|
|Intervention model||parallel assignment|
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.
Male or female participants up to 48 hours old.
- Infant admitted to Special Care Nursery at Dhaka Shishu Hospital less than 48 hours chronological age
- parental consent must be obtained
- infants being admitted for major surgical procedure which is attended by high rate of infectious complications
- 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
|Official title||Effect of Chlorhexidine Skin Cleansing on Skin Flora of Newborn Infants in Bangladesh|
|Principal investigator||Gary Darmstadt, MD|
|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.|
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