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

NCT ID: NCT01361997

Last Updated: 2016-08-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

1102 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-06-30

Study Completion Date

2012-08-31

Brief Summary

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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

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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.

Conditions

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Infectious Diseases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

chlorhexidine in isopropyl alcohol

Intervention Type BIOLOGICAL

When a hemoculture is ordered, the laboratory technician will prepare the necessary materials for venipuncture. Previously the technician must take randomly a sealed envelope, where will be writing the antiseptic to be used for antisepsis. The technician will select a site for venipuncture, preferably in the forearm, and will do the antisepsis in the site selected, letting act the substance for 45 seconds. After this procedure, the venipuncture shall be done. The sample will be cultured for 120 hours at 35 +/- 2°C.

Isopropyl alcohol

This arm is composed of 572 hospitalized patients with suspected blood stream infection, to test 70% isopropyl alcohol.

Group Type EXPERIMENTAL

Isopropyl alcohol

Intervention Type BIOLOGICAL

When a hemoculture is ordered, the laboratory technician will prepare the necessary materials for venipuncture. Previously the technician must take randomly a sealed envelope, where will be writing the antiseptic to be used for antisepsis. The technician will select a site for venipuncture, preferably in the forearm, and will do the antisepsis in the site selected, letting act the substance for 45 seconds. After this procedure, the venipuncture shall be done. The sample will be cultured for 120 hours at 35 +/- 2°C.

Interventions

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chlorhexidine in isopropyl alcohol

When a hemoculture is ordered, the laboratory technician will prepare the necessary materials for venipuncture. Previously the technician must take randomly a sealed envelope, where will be writing the antiseptic to be used for antisepsis. The technician will select a site for venipuncture, preferably in the forearm, and will do the antisepsis in the site selected, letting act the substance for 45 seconds. After this procedure, the venipuncture shall be done. The sample will be cultured for 120 hours at 35 +/- 2°C.

Intervention Type BIOLOGICAL

Isopropyl alcohol

When a hemoculture is ordered, the laboratory technician will prepare the necessary materials for venipuncture. Previously the technician must take randomly a sealed envelope, where will be writing the antiseptic to be used for antisepsis. The technician will select a site for venipuncture, preferably in the forearm, and will do the antisepsis in the site selected, letting act the substance for 45 seconds. After this procedure, the venipuncture shall be done. The sample will be cultured for 120 hours at 35 +/- 2°C.

Intervention Type BIOLOGICAL

Other Intervention Names

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Chloraprep, Enturia Inc., Texas. BacT/ALERT FA, Biomérieux Inc., North Carolina. Alcohol Swabs, BD, Madrid. BacT/ALERT FA, Biomérieux Inc., North Carolina.

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Patients with a single peripheral hemoculture.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Universidad de Guanajuato

OTHER

Sponsor Role lead

Responsible Party

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Alejandro E. Macias

Full-time professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Alejandro E. Macias, M. D.

Role: PRINCIPAL_INVESTIGATOR

Universidad de Guanajuato

Locations

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University of Guanajuato School of Medicine

León, Guanajuato, Mexico

Site Status

Countries

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Mexico

Other Identifiers

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2011HRAEB001

Identifier Type: -

Identifier Source: org_study_id

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