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

This study has been completed.
Sponsor:
Information provided by:
C.R.Darnall Army Medical Center
ClinicalTrials.gov Identifier:
NCT00297908
First received: February 27, 2006
Last updated: February 28, 2007
Last verified: February 2007
  Purpose

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
Healthy

Study Type: Observational
Study Design: Observational Model: Defined Population
Primary Purpose: Screening
Time Perspective: Longitudinal
Official Title: Alcohol Based Hand Sanitizer: Can Frequent Use Cause an Elevated Blood Alcohol Level?

Resource links provided by NLM:


Further study details as provided by C.R.Darnall Army Medical Center:

Estimated Enrollment: 5
Study Start Date: February 2006
Estimated Study Completion Date: February 2006
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.

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
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
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: 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

No publications provided

ClinicalTrials.gov Identifier: NCT00297908     History of Changes
Other Study ID Numbers: C.2006.041
Study First Received: February 27, 2006
Last Updated: February 28, 2007
Health Authority: United States: Federal Government

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

Additional relevant MeSH terms:
Hand Sanitizers
Anti-Infective Agents
Anti-Infective Agents, Local
Disinfectants
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014