Effect of Chlorhexidine Skin Cleansing on Skin Flora | NCT00198679

Studies
Effect of Chlorhexidine Skin Cleansing on Skin Flora

NCT00198679

Sponsor

Johns Hopkins Bloomberg School of Public Health

Status

Completed

Last Update Posted

Apr 20, 2018Actual

Enrollment

210

Phase

Phase 4

Conditions

Skin Diseases, Infectious

Interventions

Chlorhexidine

Countries

Bangladesh

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2006

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2004

Primary Completion Date

Mar 2005Actual

Completion Date

Mar 2005Actual

First Submitted Date

Sep 12, 2005

First Submission Date that Met QC Criteria

Sep 12, 2005

First Posted Date

Sep 20, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 18, 2018

Last Update Posted Date

Apr 20, 2018Actual

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

210

Name	Type	Description	Arm Group Labels	Other Names
Chlorhexidine	Drug

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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 Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

48 Hours

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Gary Darmstadt, MD	Johns Hopkins Bloomberg School of Public Health	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Dhaka Shishu Hospital		Dhaka			Bangladesh

Condition Browse Module

MeSH Terms

ID	Term
D012874	Skin Diseases, Infectious
D003141	Communicable Diseases

Ancestor Terms

ID	Term
D007239	Infections
D012871	Skin Diseases
D017437	Skin and Connective Tissue Diseases
D020969	Disease Attributes

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D002710	Chlorhexidine

Ancestor Terms

ID	Term
D001645	Biguanides
D006146	Guanidines
D000578	Amidines
D009930	Organic Chemicals

Browse Leaves

Not provided

Browse Branches

Not provided