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

Arm | Intervention/treatment |
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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.
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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:
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Experimental: Isopropyl alcohol
This arm is composed of 572 hospitalized patients with suspected blood stream infection, to test 70% isopropyl alcohol.
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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:
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- 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.
- 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.
- 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.

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Ages Eligible for Study: | 18 Years to 70 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

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
Mexico | |
University of Guanajuato School of Medicine | |
Leon, Guanajuato, Mexico, 37000 |
Principal Investigator: | Alejandro E. Macias, M. D. | Universidad de Guanajuato |
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 Key Record Dates |
Last Update Posted: | August 19, 2016 |
Last Verified: | August 2012 |
Antiseptics Hemoculture contamination Anti-infecting agents, local |
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 |