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

Purpose

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	Intervention	Phase
Infectious Diseases	Biological: chlorhexidine in isopropyl alcohol Biological: Isopropyl alcohol	Phase 3


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Factorial Assignment Masking: Single Blind (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

Resource links provided by NLM:

Drug Information available for: Chlorhexidine Chlorhexidine acetate Isopropyl alcohol Chlorhexidine hydrochloride Chlorhexidine gluconate Hibiclens

U.S. FDA Resources

Further study details as provided by Universidad de Guanajuato:

Primary Outcome Measures:

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 ] [ Designated as safety issue: Yes ]
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. [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
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. [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
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.


Enrollment:	1102
Study Start Date:	June 2011
Study Completion Date:	August 2012
Primary Completion Date:	August 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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.

Arms

Assigned Interventions

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.

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.

Eligibility


Ages Eligible for Study:	18 Years to 70 Years (Adult, Senior)
Genders Eligible for Study:	Both
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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.	University of Guanajuato

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
Study First Received:	May 23, 2011
Last Updated:	August 17, 2016
Health Authority:	Mexico: Secretaria de Salud

Keywords provided by 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

ClinicalTrials.gov processed this record on September 23, 2016