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

Study Overview
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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.

Official Title
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The Efficacy of 2% Chlorhexidine Gluconate in 70% Alcohol Compared With 10% Povidone Iodine in Reducing Blood Culture Contamination in Pediatric Patients

Conditions
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Bacteremia

Intervention / Treatment
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* Drug: 2% chlorhexidine gluconate in 70% alcohol
* Drug: 10%povidone iodine


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 1 Day
Maximum Age: 15 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 2% Chlorhexidine Gluconate<br>apply 2% Chlorhexidine Gluconate in 70% Alcohol on skin before venipuncture | Drug: 2% chlorhexidine gluconate in 70% alcohol<br>* skin preparation before venipuncture for blood culture in even month<br>* Other names: Chloraprep;|
| Active Comparator: 10% povidone iodine<br>apply 10% povidone iodine on the skin before venipuncture | Drug: 10%povidone iodine<br>* skin preparation before venipuncture for blood culture in odd month<br>* Other names: Betadine;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| efficacy of 2% chlorhexidine gluconate in 70% alcohol compared with 10% povidone iodine | Pediatric patients who needed percutaneous blood cultures were recruited and were assigned 10% povidone iodine in odd months and 2% chlorhexidine gluconate in 70% alcohol in even months as an antiseptic for blood cultures. Blood culture isolates were categorized into two groups including a true pathogen and a contaminant by clinical criteria combined with laboratory data. | 5 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| safety of 2% chlorhexidine gluconate in 70% alcohol compared with 10% povidone iodine | direct observe skin reaction after use both antiseptics | 48 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Blood culture, Contamination, Chlorhexidine gluconate, Povidone iodine