Isopropyl Alcohol Against Chlorhexidine - Isopropyl Alcohol as Antiseptics to Prevent Hemoculture's Contamination

Phase 3

Completed

• Conditions: Infectious Diseases
• Interventions: Biological: chlorhexidine in isopropyl alcohol; Biological: Isopropyl alcohol

• Registration Number: NCT01361997
• Lead Sponsor: Universidad de Guanajuato

Brief Summary

The purpose of this study is to determinate if 70% isopropyl alcohol is not inferior preventing contamination of peripheral hemocultures, compared with 2% chlorhexidine in 70% isopropyl alcohol.

Detailed Description

The develop of contaminants in blood cultures is a problem of great impact to health institutions and patients, as they represent a waste of resources, and additionally increases the patient's hospital stay. The principal source of contaminant is the bacteria in the skin flora, so the greatest way to improve the sensibility of this test is to do an optimal skin antisepsis. It has been reported that 2% chlorhexidine gluconate in 70% isopropyl alcohol is superior that other skin disinfectants, and that 70% isopropyl alcohol has a high efficacy reducing the presence of bacteria on the skin, so both antiseptics are good options for skin antisepsis.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2011-05-23
• Study First Submitted QC: 2011-05-26
• Study First Posted: 2011-05-27
• Study Start: 2011-06
• Status Verified: 2012-08
• Primary Completion: 2012-08
• Study Completion: 2012-08
• Last Update Submitted: 2016-08-17
• Last Update Posted: 2016-08-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1102

Inclusion Criteria

• Patients with suspected blood stream infection.
• Patients allocated in admission, hospitalization and intensive care units.

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Exclusion Criteria

• Patients with a single peripheral hemoculture.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Chlorhexidine in isopropyl alcohol	chlorhexidine in isopropyl alcohol	This arm is composed of 545 hospitalized patients with suspected blood stream infection, to test 2% chlorhexidine gluconate in 70% isopropyl alcohol.
Isopropyl alcohol	Isopropyl alcohol	This arm is composed of 572 hospitalized patients with suspected blood stream infection, to test 70% isopropyl alcohol.

Primary Outcome Measures

Name	Time	Method
Determine if 70% isopropyl alcohol is not inferior preventing contamination of peripheral hemoculture, compared with 2% chlorhexidine in 70% isopropyl alcohol.	120 hours	It will determine the growth of contaminating germs in hemocultures taken with each antiseptic tested.

Secondary Outcome Measures

Name	Time	Method
Determine the rate of contamination of each antiseptic used.	1 year	It will determine the rate of contamination at the date of primary completion and the date of study completion. We will consider contaminants the development of Staphylococcus coagulase negative and gram positive bacilli.
Description of the most frequent bacterial contaminants.	1 year	It will determine the rate of contamination at the date of primary completion and the date of study completion. We will consider contaminants the development of Staphylococcus coagulase negative and gram positive bacilli.

Trial Locations

Locations (1)

University of Guanajuato School of Medicine; 🇲🇽 Leon, Guanajuato, Mexico