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

Primary Purpose

Infectious Diseases

Status
Completed
Phase
Phase 3
Locations
Mexico
Study Type
Interventional
Intervention
chlorhexidine in isopropyl alcohol
Isopropyl alcohol
Sponsored by
Universidad de Guanajuato
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Infectious Diseases focused on measuring Antiseptics, Hemoculture contamination, Anti-infecting agents, local

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of Guanajuato School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Chlorhexidine in isopropyl alcohol

Isopropyl alcohol

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Determine the rate of contamination of each antiseptic used.
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.
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.

Full Information

First Posted
May 23, 2011
Last Updated
August 17, 2016
Sponsor
Universidad de Guanajuato
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1. Study Identification

Unique Protocol Identification Number
NCT01361997
Brief Title
Isopropyl Alcohol Against Chlorhexidine - Isopropyl Alcohol as Antiseptics to Prevent Hemoculture's Contamination
Official Title
Comparative Study of 70% Isopropyl Alcohol Against 2% Chlorhexidine- 70% Isopropyl Alcohol as Antiseptics to Prevent Hemoculture's Contamination
Study Type
Interventional

2. Study Status

Record Verification Date
August 2012
Overall Recruitment Status
Completed
Study Start Date
June 2011 (undefined)
Primary Completion Date
August 2012 (Actual)
Study Completion Date
August 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad de Guanajuato

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infectious Diseases
Keywords
Antiseptics, Hemoculture contamination, Anti-infecting agents, local

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Factorial Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
1102 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Chlorhexidine in isopropyl alcohol
Arm Type
Experimental
Arm Description
This arm is composed of 545 hospitalized patients with suspected blood stream infection, to test 2% chlorhexidine gluconate in 70% isopropyl alcohol.
Arm Title
Isopropyl alcohol
Arm Type
Experimental
Arm Description
This arm is composed of 572 hospitalized patients with suspected blood stream infection, to test 70% isopropyl alcohol.
Intervention Type
Biological
Intervention Name(s)
chlorhexidine in isopropyl alcohol
Other Intervention Name(s)
Chloraprep, Enturia Inc., Texas., BacT/ALERT FA, Biomérieux Inc., North Carolina.
Intervention Description
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
Intervention Name(s)
Isopropyl alcohol
Other Intervention Name(s)
Alcohol Swabs, BD, Madrid., BacT/ALERT FA, Biomérieux Inc., North Carolina.
Intervention Description
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.
Primary Outcome Measure Information:
Title
Determine if 70% isopropyl alcohol is not inferior preventing contamination of peripheral hemoculture, compared with 2% chlorhexidine in 70% isopropyl alcohol.
Description
It will determine the growth of contaminating germs in hemocultures taken with each antiseptic tested.
Time Frame
120 hours
Secondary Outcome Measure Information:
Title
Determine the rate of contamination of each antiseptic used.
Description
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.
Time Frame
1 year
Title
Description of the most frequent bacterial contaminants.
Description
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.
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alejandro E. Macias, M. D.
Organizational Affiliation
Universidad de Guanajuato
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Guanajuato School of Medicine
City
Leon
State/Province
Guanajuato
ZIP/Postal Code
37000
Country
Mexico

12. IPD Sharing Statement

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

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