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

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

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.

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

• 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

Arms and Interventions

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

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

• Ages Eligible for Study: 18 Years to 70 Years (Adult, Older Adult)
• 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

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

• Responsible Party: Alejandro E. Macias, Full-time professor, Universidad de Guanajuato
• ClinicalTrials.gov Identifier: NCT01361997
• Other Study ID Numbers: 2011HRAEB001
• First Posted: May 27, 2011
• 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; Infections; Disease Attributes; Pathologic Processes; Ethanol; Chlorhexidine; Anti-Infective Agents, Local; Anti-Infective Agents; Central Nervous System Depressants; Physiological Effects of Drugs; Disinfectants