• Comparison of Blood Culture Contamination Rates

Comparison of Blood Culture Contamination Rates Between the Use of Povidine Iodine/Alcohol for Skin Antisepsis and the Use of Chlorhexidine/Alcohol (ChloraPrep) for Skin Antisepsis: An Open-label, Randomized Controlled Trial

In this study, blood culture contamination rates will be compared in patients who used povidine/iodine-alcohol and chlorhexidine/alcohol, which were applied before the blood culture was taken by randomized two methods routinely used in this study.

Study Overview

• Status: Not yet recruiting
• Conditions: Blood Culture Contamination
• Intervention / Treatment: Procedure: disinfection of the surface that the blood culture is taken

Detailed Description

Detection of the pathogen in blood cultures as soon as possible reduces mortality significantly by providing timely initiation of treatment1. However, when skin antisepsis is not performed properly, an increase in the rate of contamination is observed. In this study, it was planned to compare the contamination rate of two antiseptics, povidine iodine/alcohol and Chlorhexidine/alcohol used as skin antisepsis, in the blood culture taken.

Full randomization" will be applied in the study. Multiples of 3 of the patients to be included in the study will be included in the "Chloraprep" group, the remaining patients and multiples of 2 will be included in the "povidine/iodine" group. . According to the number of samples determined for each institution, patients who came to the outpatient clinic during data collection and accepted to participate in the study will be randomly selected.

• Study Type: Interventional
• Enrollment (Anticipated): 500
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 16 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• patients who will be hospitalized at SBU Izmir Dr. Patients who are hospitalized in the Pediatric Infection Service of Behçet Uz Pediatrics and Surgery Training and Research Hospital, and who will require blood culture indications will participate in the study If they are willing to

Exclusion Criteria:

• The patents with central lines will be excluded.
• The patient who were transferred from ICU's will be excluded.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 1.The culture taken after disinfection with providing/iodine; 1.Blood cultures routinely performed with alcohol/povidine-iodine	Procedure: disinfection of the surface that the blood culture is taken; lood cultures can be routinely performed with alcohol/povidine-iodine or alcohol/chlorhexidine. The topical disinfectants used in the two applications are the topical disinfectants included in the guidelines and currently applied in our hospital.
Active Comparator: 2.The culture taken after disinfection with chlorhexidine/alcohol; 2. Blood cultures routinely performed with chlorhexidine/alcohol	Procedure: disinfection of the surface that the blood culture is taken; lood cultures can be routinely performed with alcohol/povidine-iodine or alcohol/chlorhexidine. The topical disinfectants used in the two applications are the topical disinfectants included in the guidelines and currently applied in our hospital.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blood Contamination	The primary endpoint of the study was to reduce the rate of contamination in blood cultures.	14 days

Collaborators and Investigators

• Sponsor: Dr. Behcet Uz Children's Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): November 15, 2022
• Primary Completion (Anticipated): November 1, 2024
• Study Completion (Anticipated): December 1, 2024

Study Registration Dates

• First Submitted: October 9, 2022
• First Submitted That Met QC Criteria: October 9, 2022
• First Posted (Actual): October 12, 2022

Study Record Updates

• Last Update Posted (Actual): October 12, 2022
• Last Update Submitted That Met QC Criteria: October 9, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Keywords: Blood culture contamination; Chloraprep ( alcohol/ chlorhexidine); Povidine/iodine; Topical disinfectants
• Other Study ID Numbers: skin antisepsis study

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No