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

Phase 4

Completed

• Conditions: Bacteremia
• Interventions: Drug: 10%povidone iodine; Drug: 2% chlorhexidine gluconate in 70% alcohol

• Registration Number: NCT01919593
• Lead Sponsor: Thammasat University

Brief Summary

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

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.

Study Timeline

• Study Start: 2012-01
• Primary Completion: 2012-12
• Study Completion: 2013-04
• Status Verified: 2013-08
• Study First Submitted: 2013-08-06
• Study First Submitted QC: 2013-08-06
• Study First Posted: 2013-08-09
• Last Update Submitted: 2013-08-09
• Last Update Posted: 2013-08-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1269

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
10% povidone iodine	10%povidone iodine	apply 10% povidone iodine on the skin before venipuncture
2% Chlorhexidine Gluconate	2% chlorhexidine gluconate in 70% alcohol	apply 2% Chlorhexidine Gluconate in 70% Alcohol on skin before venipuncture

Primary Outcome Measures

Name	Time	Method
efficacy of 2% chlorhexidine gluconate in 70% alcohol compared with 10% povidone iodine	5 days	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.

Secondary Outcome Measures

Name	Time	Method
safety of 2% chlorhexidine gluconate in 70% alcohol compared with 10% povidone iodine	48 hours	direct observe skin reaction after use both antiseptics

Trial Locations

Locations (1)

Thammasat University hospital; 🇹🇭 Klong luang, Pathumthanii, Thailand