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

Primary Purpose

Bacteremia

Status
Completed
Phase
Phase 4
Locations
Thailand
Study Type
Interventional
Intervention
2% chlorhexidine gluconate in 70% alcohol
10%povidone iodine
Sponsored by
Thammasat University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Bacteremia focused on measuring Blood culture, Contamination, Chlorhexidine gluconate, Povidone iodine

Eligibility Criteria

1 Day - 15 Years (Child)All SexesDoes not accept 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

Sites / Locations

  • Thammasat University hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

2% Chlorhexidine Gluconate

10% povidone iodine

Arm Description

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

apply 10% povidone iodine on the skin before venipuncture

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
August 6, 2013
Last Updated
August 9, 2013
Sponsor
Thammasat University
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1. Study Identification

Unique Protocol Identification Number
NCT01919593
Brief Title
Efficacy of 2% Chlorhexidine Gluconate in 70% Alcohol Compare 10% Povidone Iodine in Blood Culture in Children
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 Type
Interventional

2. Study Status

Record Verification Date
August 2013
Overall Recruitment Status
Completed
Study Start Date
January 2012 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
April 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Thammasat University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bacteremia
Keywords
Blood culture, Contamination, Chlorhexidine gluconate, Povidone iodine

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1269 (Actual)

8. Arms, Groups, and Interventions

Arm Title
2% Chlorhexidine Gluconate
Arm Type
Experimental
Arm Description
apply 2% Chlorhexidine Gluconate in 70% Alcohol on skin before venipuncture
Arm Title
10% povidone iodine
Arm Type
Active Comparator
Arm Description
apply 10% povidone iodine on the skin before venipuncture
Intervention Type
Drug
Intervention Name(s)
2% chlorhexidine gluconate in 70% alcohol
Other Intervention Name(s)
Chloraprep
Intervention Description
skin preparation before venipuncture for blood culture in even month
Intervention Type
Drug
Intervention Name(s)
10%povidone iodine
Other Intervention Name(s)
Betadine
Intervention Description
skin preparation before venipuncture for blood culture in odd month
Primary Outcome Measure Information:
Title
efficacy of 2% chlorhexidine gluconate in 70% alcohol compared with 10% povidone iodine
Description
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.
Time Frame
5 days
Secondary Outcome Measure Information:
Title
safety of 2% chlorhexidine gluconate in 70% alcohol compared with 10% povidone iodine
Description
direct observe skin reaction after use both antiseptics
Time Frame
48 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Day
Maximum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Auchara Tangsathapornponng, MD
Organizational Affiliation
Faculty of Medicine, Thammasat University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Thammasat University hospital
City
Klong luang
State/Province
Pathumthanii
ZIP/Postal Code
10900
Country
Thailand

12. IPD Sharing Statement

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

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