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Alcohol Based Hand Sanitizer: Can Frequent Use Cause an Elevated Blood Alcohol Level?

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ClinicalTrials.gov Identifier: NCT00297908
Recruitment Status : Completed
First Posted : March 1, 2006
Last Update Posted : June 3, 2015
Sponsor:
Information provided by:

Study Description
Brief Summary:
Ethanol based hand sanitizers do not raise blood alcohol levels to a measurable amount. This study will determine to what extent, if any, heavy use of ABHS changes blood alcohol levels.

Condition or disease
Healthy

Detailed Description:

Ethanol continues to be the most frequently abused intoxicant in the United States.4 Drug testing in various work environments has become commonplace during the past two decades and will at times include blood, breath, or urine alcohol testing.5 While valid reasons for false positive drug tests do occur, a plethora of unusual and dubious explanations have been likewise tendered. Medical Review Officers (MRO) involved in evaluating such reports rely on past case reports, knowledge of laboratory analytical techniques, and other scientific evidence to validate or negate claims of drug use in the workplace. ABHS are now found in most hospitals and health-care facilities.1,3 Only one human report of serum ethanol levels following frequent clinical use of the ABHS has been reported.7 This finding of a negative serum ethanol level in this case is likely to be reproducible in all clinical settings as the physician attempted to simulate the most extreme use of the product that would be consistent with labeling instructions. Since alcohol breathalyzer testing is based upon exhaled portions of ethanol found within the blood stream, this method of testing would likely be negative as well.

Participants will be the investigators and associate investigators of the study, who are all employees in the emergency department at Darnall Army Community Hospital. There will be no financial reward offered. Consent will be obtained on all participants. The study will be performed in the Darnall Emergency Department outside of regular duty hours. Enrolled subjects will apply 5 ml of the product (62% denatured ethanol alcohol manufactured by Kimberley-Clark) to both hands and rub until dry. This will be repeated 50 times over approximately 4 hours. Participants will have their blood drawn prior to, as well as, after completing the study. No other laboratory tests will be performed other than the alcohol level. Pre study blood alcohol levels will be ordered to assure a pre-study level of 0 mg/dl.


Study Design

Study Type : Observational
Estimated Enrollment : 5 participants
Time Perspective: Prospective
Official Title: Alcohol Based Hand Sanitizer: Can Frequent Use Cause an Elevated Blood Alcohol Level?
Study Start Date : February 2006
Estimated Study Completion Date : February 2006

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts


Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Adults between the ages of 18 and 50 years without liver or renal disease working in the emergency department to include residents and staff physicians.

Exclusion Criteria:

  • Alcohol intake or exposure in the past 12 hours to include ABHS.
  • Allergy to ABHS or any of its ingredients.
  • Any rash on the extremities.
  • Currently taking disulfiram , metronidazole, chloramphenicol, nitrofurantoin, tolbutamide, chlorpropamide, glyburide, glipizide, tolazamide, griseofulvin, chloral hydrate, acetohexamide, and third-generation cephalosporins.
  • Liver or kidney disease.
Contacts and Locations

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): NCT00297908


Locations
United States, Texas
Darnall Army Community Hospital
Ft. Hood, Texas, United States, 76544
Sponsors and Collaborators
C.R.Darnall Army Medical Center
Investigators
Study Chair: Michael Luszczak, DO C.R.Darnall Army Medical Center
More Information

Publications:
ClinicalTrials.gov Identifier: NCT00297908     History of Changes
Other Study ID Numbers: C.2006.041
First Posted: March 1, 2006    Key Record Dates
Last Update Posted: June 3, 2015
Last Verified: February 2007

Keywords provided by C.R.Darnall Army Medical Center:
Ethanol levels
Dermal absorbtion

Additional relevant MeSH terms:
Hand Sanitizers
Anti-Infective Agents, Local
Anti-Infective Agents
Disinfectants