• Comparison of Blood Culture Contamination Rates

October 9, 2022 updated by: ilker devrim, Dr. Behcet Uz Children's Hospital

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

Intervention / Treatment

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 years to 14 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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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
Time Frame: 14 days
The primary endpoint of the study was to reduce the rate of contamination in blood cultures.
14 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dr. Behcet Uz Children's Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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