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

Sponsor
C.R.Darnall Army Medical Center (U.S. Fed)
Overall Status
Completed
CT.gov ID
NCT00297908
Collaborator
(none)
5
1

Study Details

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 Intervention/Treatment Phase

    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
    Time Perspective:
    Prospective
    Official Title:
    Alcohol Based Hand Sanitizer: Can Frequent Use Cause an Elevated Blood Alcohol Level?
    Study Start Date :
    Feb 1, 2006
    Study Completion Date :
    Feb 1, 2006

    Outcome Measures

    Primary Outcome Measures

      Eligibility Criteria

      Criteria

      Ages Eligible for Study:
      18 Years to 50 Years
      Sexes Eligible for Study:
      All
      Accepts Healthy Volunteers:
      Yes
      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

      Locations

      Site City State Country Postal Code
      1 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

      Study Documents (Full-Text)

      None provided.

      More Information

      Publications

      Responsible Party:
      , ,
      ClinicalTrials.gov Identifier:
      NCT00297908
      Other Study ID Numbers:
      • C.2006.041
      First Posted:
      Mar 1, 2006
      Last Update Posted:
      Jun 3, 2015
      Last Verified:
      Feb 1, 2007
      Keywords provided by , ,

      Study Results

      No Results Posted as of Jun 3, 2015