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

NCT01919593 | Completed Phase 4

• 1 other identifier: MTU-PE-3-053/55
• Study Type: interventional
• Target: 1,269
• Locations: 1 country
• Sites: 1

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.

Conditions

Bacteremia

Keywords

Blood culture; Contamination; Chlorhexidine gluconate; Povidone iodine

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• safety of 2% chlorhexidine gluconate in 70% alcohol compared with 10% povidone iodine

  48 hours

Study Arms (2)

2% Chlorhexidine Gluconate

EXPERIMENTAL

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

Drug: 2% chlorhexidine gluconate in 70% alcohol

10% povidone iodine

ACTIVE COMPARATOR

apply 10% povidone iodine on the skin before venipuncture

Drug: 10%povidone iodine

Interventions

2% chlorhexidine gluconate in 70% alcohol DRUG

skin preparation before venipuncture for blood culture in even month

Also known as: Chloraprep

2% Chlorhexidine Gluconate

10%povidone iodine DRUG

skin preparation before venipuncture for blood culture in odd month

Also known as: Betadine

10% povidone iodine

Eligibility Criteria

• Age: 1 Day - 15 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Thammasat University: lead

Study Sites (1)

Thammasat University hospital

Klong Luang, Pathumthanii, 10900, Thailand

Location

MeSH Terms

Conditions

Bacteremia

Interventions

chlorhexidine gluconate; Ethanol; Povidone-Iodine

Condition Hierarchy (Ancestors)

Bacterial Infections; Bacterial Infections and Mycoses; Infections; Sepsis; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Alcohols; Organic Chemicals; Iodophors; Iodine Compounds; Inorganic Chemicals; Polyvinyls; Vinyl Compounds; Alkenes; Hydrocarbons, Acyclic; Hydrocarbons; Povidone; Pyrrolidinones; Pyrrolidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Plastics; Polymers; Macromolecular Substances; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture

Study Officials

• Auchara Tangsathapornponng, MD

  Faculty of Medicine, Thammasat University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: August 6, 2013
• First Posted: August 9, 2013
• Study Start: January 1, 2012
• Primary Completion: December 1, 2012
• Study Completion: April 1, 2013
• Last Updated: August 13, 2013

Record last verified: 2013-08

Locations

TH (1)