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

T

Thammasat University

Status and phase

Completed
Phase 4

Conditions

Bacteremia

Treatments

Drug: 10%povidone iodine
Drug: 2% chlorhexidine gluconate in 70% alcohol

Study type

Interventional

Funder types

Other

Identifiers

NCT01919593
MTU-PE-3-053/55

Details and patient eligibility

About

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

Full 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.

Enrollment

1,269 patients

Sex

All

Ages

1 day to 15 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

1,269 participants in 2 patient groups

2% Chlorhexidine Gluconate
Experimental group
Description:
apply 2% Chlorhexidine Gluconate in 70% Alcohol on skin before venipuncture
Treatment:
Drug: 2% chlorhexidine gluconate in 70% alcohol
10% povidone iodine
Active Comparator group
Description:
apply 10% povidone iodine on the skin before venipuncture
Treatment:
Drug: 10%povidone iodine

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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