Skin Sterility After Ethyl-Chloride Spray
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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 |
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Skin Sterility After Use of Ethyl-chloride Spray. |
| Study Type: | Observational |
| Study Design: | Time Perspective: Prospective |
| Official Title: | Skin Sterility After Ethyl-Chloride Spray |
- 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.
- 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 |
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Healthy Volunteers
15 healthy volunteers were recruited
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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 |
Healty adult (18-85) volunteers
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| United States, New Jersey | |
| UMDNJ UH | |
| Newark, New Jersey, United States, 07103 | |
| Principal Investigator: | Robin M Gehrmann, MD | University of Medicine and Dentistry 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 University of Medicine and Dentistry New Jersey:
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Topical Skin sterility ethylchloride |
ethyl chloride spray |
Additional relevant MeSH terms:
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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 May 19, 2013