Isopropyl Alcohol Against Chlorhexidine - Isopropyl Alcohol as Antiseptics to Prevent Hemoculture's Contamination
This study has been completed.
Sponsor:
Universidad de Guanajuato
Information provided by (Responsible Party):
Alejandro E. Macias, Universidad de Guanajuato
ClinicalTrials.gov Identifier:
NCT01361997
First received: May 23, 2011
Last updated: August 11, 2012
Last verified: August 2012
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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: Skin antisepsis |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-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:
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.
| Estimated Enrollment: | 966 |
| 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 483 hospitalized patients with suspected blood stream infection, to test 2% chlorhexidine gluconate in 70% isopropyl alcohol.
|
Biological: Skin antisepsis
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:
|
|
Experimental: Isopropyl alcohol
This arm is composed of 483 hospitalized patients with suspected blood stream infection, to test 70% isopropyl alcohol.
|
Biological: Skin antisepsis
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:
|
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 |
| 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
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
No publications provided
| 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 11, 2012 |
| 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 Anti-Infective Agents, Local Chlorhexidine Chlorhexidine gluconate Anti-Infective Agents |
Therapeutic Uses Pharmacologic Actions Central Nervous System Depressants Physiological Effects of Drugs Central Nervous System Agents Disinfectants Dermatologic Agents |
ClinicalTrials.gov processed this record on May 21, 2013