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Efficacy of 2% Chlorhexidine Gluconate in 70% Alcohol Compare 10% Povidone Iodine in Blood Culture in Children

NCT ID: NCT01919593

Last Updated: 2013-08-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

1269 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-01-31

Study Completion Date

2013-04-30

Brief Summary

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To evaluate the efficacy of 2% chlorhexidine gluconate in 70% alcohol compared with 10% povidone iodine in reducing blood culture contamination in pediatric patients.

Detailed Description

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This is a prospective study of pediatric patients between 0-15 years of age who were admitted in three pediatric wards: general pediatric ward aged \<5 years, general pediatric ward aged \>5 years, and pediatric intensive care unit at a tertiary-care teaching hospital. Patients who needed percutaneous blood cultures were eligible for enrollment and were classified into two groups according to antiseptic used: 10% povidone iodine in odd months and 2% chlorhexidine gluconate in 70% alcohol in even months. Blood cultures were taken primarily by ward nurses using standard technique. The blood cultures were analysed and monitored for 5 days. Isolated organisms and their antimicrobial susceptibilities were determined using standard microbiologic techniques.

Blood culture isolates were categorized into two groups including a true pathogen and a contaminant by clinical criteria combined with laboratory data. A blood culture was classified as contaminated if common skin flora such as Coagulase negative staphylococci, Corynebacterium spp., Micrococcus spp., or Bacillus spp. were isolated from one of the blood culture samples without isolation of the same organism from another potential infection site (for example, intravenous catheter), or a common skin flora was isolated in a patient with incompatible clinical features and improved without specific treatment for that organism.

Conditions

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Bacteremia

Keywords

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Blood culture Contamination Chlorhexidine gluconate Povidone iodine

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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2% Chlorhexidine Gluconate

apply 2% Chlorhexidine Gluconate in 70% Alcohol on skin before venipuncture

Group Type EXPERIMENTAL

2% chlorhexidine gluconate in 70% alcohol

Intervention Type DRUG

skin preparation before venipuncture for blood culture in even month

10% povidone iodine

apply 10% povidone iodine on the skin before venipuncture

Group Type ACTIVE_COMPARATOR

10%povidone iodine

Intervention Type DRUG

skin preparation before venipuncture for blood culture in odd month

Interventions

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2% chlorhexidine gluconate in 70% alcohol

skin preparation before venipuncture for blood culture in even month

Intervention Type DRUG

10%povidone iodine

skin preparation before venipuncture for blood culture in odd month

Intervention Type DRUG

Other Intervention Names

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Chloraprep Betadine

Eligibility Criteria

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Inclusion Criteria

* Pediatric patients between 0-15 years of age who were admitted in three pediatric wards: general pediatric ward aged \<5 years, general pediatric ward aged \>5 years, and pediatric intensive care unit. Patients who needed percutaneous blood cultures were eligible for enrollment.

Exclusion Criteria

* Preterm infant
* Patient who had skin infection at site of venepuncture
* Patient who had history allergy to 2% Chlorhexidine gluconate in 70% alcohol or 10% povidone-iodine
Minimum Eligible Age

1 Day

Maximum Eligible Age

15 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Thammasat University

OTHER

Sponsor Role lead

Responsible Party

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Auchara Tangsathapornpong

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Auchara Tangsathapornponng, MD

Role: PRINCIPAL_INVESTIGATOR

Faculty of Medicine, Thammasat University

Locations

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Thammasat University hospital

Klong Luang, Pathumthanii, Thailand

Site Status

Countries

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Thailand

Other Identifiers

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MTU-PE-3-053/55

Identifier Type: -

Identifier Source: org_study_id