Efficacy of 2% Chlorhexidine Gluconate in 70% Alcohol Compare 10% Povidone Iodine in Blood Culture in Children
Information source: Thammasat University
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Bacteremia
Intervention: 2% chlorhexidine gluconate in 70% alcohol (Drug); 10%povidone iodine (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Thammasat University Official(s) and/or principal investigator(s):
Auchara Tangsathapornponng, MD, Principal Investigator, Affiliation: Faculty of Medicine, Thammasat University
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.
Clinical Details
Official title: The Efficacy of 2% Chlorhexidine Gluconate in 70% Alcohol Compared With 10% Povidone Iodine in Reducing Blood Culture Contamination in Pediatric Patients
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
Primary outcome: efficacy of 2% chlorhexidine gluconate in 70% alcohol compared with 10% povidone iodine
Secondary outcome: safety of 2% chlorhexidine gluconate in 70% alcohol compared with 10% povidone iodine
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.
Eligibility
Minimum age: N/A.
Maximum age: 15 Years.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Thammasat University hospital, Klong luang, Pathumthanii 10900, Thailand
Additional Information
Starting date: January 2012
Last updated: August 9, 2013
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