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

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ClinicalTrials.gov Identifier: NCT01361997
Recruitment Status : Completed
First Posted : May 27, 2011
Last Update Posted : August 19, 2016
Sponsor:
Information provided by (Responsible Party):
Alejandro E. Macias, Universidad de Guanajuato

Study Description
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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.

Condition or disease Intervention/treatment Phase
Infectious Diseases Biological: chlorhexidine in isopropyl alcohol Biological: Isopropyl alcohol Phase 3

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1102 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Comparative Study of 70% Isopropyl Alcohol Against 2% Chlorhexidine- 70% Isopropyl Alcohol as Antiseptics to Prevent Hemoculture's Contamination
Study Start Date : June 2011
Actual Primary Completion Date : August 2012
Actual Study Completion Date : August 2012

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U.S. FDA Resources

Arms and Interventions
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: 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.
 Biological: 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.
Other Names:
  • Chloraprep, Enturia Inc., Texas.
  • BacT/ALERT FA, Biomérieux Inc., North Carolina.
Experimental: Isopropyl alcohol
This arm is composed of 572 hospitalized patients with suspected blood stream infection, to test 70% isopropyl alcohol.
 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.
Other Names:
  • Alcohol Swabs, BD, Madrid.
  • BacT/ALERT FA, Biomérieux Inc., North Carolina.


Outcome Measures
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Primary Outcome Measures :
  1. Determine if 70% isopropyl alcohol is not inferior preventing contamination of peripheral hemoculture, compared with 2% chlorhexidine in 70% isopropyl alcohol. [ Time Frame: 120 hours ]
    It will determine the growth of contaminating germs in hemocultures taken with each antiseptic tested.


Secondary Outcome Measures :
  1. Determine the rate of contamination of each antiseptic used. [ Time Frame: 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.

  2. Description of the most frequent bacterial contaminants. [ Time Frame: 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01361997


Locations
Mexico
University of Guanajuato School of Medicine
Leon, Guanajuato, Mexico, 37000
Sponsors and Collaborators
Universidad de Guanajuato
Investigators
Principal Investigator: Alejandro E. Macias, M. D. Universidad de Guanajuato
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: Alejandro E. Macias, Full-time professor, Universidad de Guanajuato
ClinicalTrials.gov Identifier: NCT01361997     History of Changes
Other Study ID Numbers: 2011HRAEB001
First Posted: May 27, 2011    Key Record Dates
Last Update Posted: August 19, 2016
Last Verified: August 2012

Keywords provided by Alejandro E. Macias, Universidad de Guanajuato:
Antiseptics
Hemoculture contamination
Anti-infecting agents, local

Additional relevant MeSH terms:
Communicable Diseases
Infection
Ethanol
Chlorhexidine
Chlorhexidine gluconate
Anti-Infective Agents, Local
 Anti-Infective Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Disinfectants
Dermatologic Agents