Skin Sterility After Ethyl-Chloride Spray

This study has been completed.
Sponsor:
Information provided by:
Rutgers, The State University of New Jersey
ClinicalTrials.gov Identifier:
NCT01292850
First received: February 8, 2011
Last updated: February 9, 2011
Last verified: February 2011
  Purpose

The aim of this study is to investigate sterility of ethyl-chloride topical anesthetic spray when used prior to an injection. The hypothesis is that the spray does not change the sterility of the injection site after skin is prepped.


Condition
Skin Sterility After Use of Ethyl-chloride Spray.

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Skin Sterility After Ethyl-Chloride Spray

Resource links provided by NLM:


Further study details as provided by Rutgers, The State University of New Jersey:

Primary Outcome Measures:
  • culture positivity [ Time Frame: 5 days ] [ Designated as safety issue: No ]
    Cultures before and after Ethyl-Chloride spray are compared to see if there is any difference.


Secondary Outcome Measures:
  • Native skin flora [ Time Frame: 5days ] [ Designated as safety issue: No ]
    Cultures of skin prior to skin prep are taken to define to native flora at the shoulder and knee area.


Enrollment: 15
Study Start Date: February 2009
Study Completion Date: October 2010
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
Healthy Volunteers
15 healthy volunteers were recruited

Detailed Description:

This is an IRB-approved, prospective, blinded, controlled study. In the first set of experiments, skin sterility is assessed. Healthy adult subjects are prepared for mock injections of shoulders and knees. No injection is performed. Each site has a set of 3 skin cultures: 1) prior to the alcohol prep (pre-prep), 2) post-alcohol prep (pre-spray), and 3) after ethyl-chloride was sprayed on the site (post-spray). In the second set of experiments, sterility of ethyl chloride is tested directly by culturing the liquid from the spray bottles.

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Healty adult (18-85) volunteers

Criteria

Inclusion Criteria:

  • age -- 18-85
  • healthy skin at shoulder and knee area

Exclusion Criteria:

  • allergy to ethyl-chloride
  • skin lesions at shoulder or knee
  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: NCT01292850

Locations
United States, New Jersey
UMDNJ UH
Newark, New Jersey, United States, 07103
Sponsors and Collaborators
University of Medicine and Dentistry of New Jersey
Investigators
Principal Investigator: Robin M Gehrmann, MD Rutgers, The State University of New Jersey
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Robin Gehrmann, M.D. Assistant Professor Department of Orthopaedics, Chief of Sports Medicine, New Jersey Medical School, UMDNJ
ClinicalTrials.gov Identifier: NCT01292850     History of Changes
Other Study ID Numbers: 0120080090
Study First Received: February 8, 2011
Last Updated: February 9, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Rutgers, The State University of New Jersey:
Topical
Skin
sterility
ethylchloride
ethyl
chloride
spray

Additional relevant MeSH terms:
Infertility
Genital Diseases, Male
Genital Diseases, Female
Ethyl Chloride
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on September 18, 2014