Skin Sterility After Ethyl-Chloride Spray
February 9, 2011 updated by: University of Medicine and Dentistry of New Jersey
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.
Study Overview
Status
Completed
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.
Study Type
Observational
Enrollment (Actual)
15
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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New Jersey
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Newark, New Jersey, United States, 07103
- UMDNJ UH
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 85 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Healty adult (18-85) volunteers
Description
Inclusion Criteria:
- age -- 18-85
- healthy skin at shoulder and knee area
Exclusion Criteria:
- allergy to ethyl-chloride
- skin lesions at shoulder or knee
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Healthy Volunteers
15 healthy volunteers were recruited
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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culture positivity
Time Frame: 5 days
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Cultures before and after Ethyl-Chloride spray are compared to see if there is any difference.
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5 days
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Native skin flora
Time Frame: 5days
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Cultures of skin prior to skin prep are taken to define to native flora at the shoulder and knee area.
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5days
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Robin M Gehrmann, MD, Rutgers, The State University of New Jersey
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Cohen Reis E, Holubkov R. Vapocoolant spray is equally effective as EMLA cream in reducing immunization pain in school-aged children. Pediatrics. 1997 Dec;100(6):E5. doi: 10.1542/peds.100.6.e5.
- Saltzman MD, Nuber GW, Gryzlo SM, Marecek GS, Koh JL. Efficacy of surgical preparation solutions in shoulder surgery. J Bone Joint Surg Am. 2009 Aug;91(8):1949-53. doi: 10.2106/JBJS.H.00768.
- Armstrong P, Young C, McKeown D. Ethyl chloride and venepuncture pain: a comparison with intradermal lidocaine. Can J Anaesth. 1990 Sep;37(6):656-8. doi: 10.1007/BF03006485.
- Soueid A, Richard B. Ethyl chloride as a cryoanalgesic in pediatrics for venipuncture. Pediatr Emerg Care. 2007 Jun;23(6):380-3. doi: 10.1097/01.pec.0000278396.25129.3f.
- Weiss JE, Uribe AG, Malleson PN, Kimura Y. Anesthesia for intra-articular corticosteroid injections in juvenile idiopathic arthritis: A survey of pediatric rheumatologists. Pediatr Rheumatol Online J. 2010 Jan 13;8:3. doi: 10.1186/1546-0096-8-3.
- Burney K, Bowker K, Reynolds R, Bradley M. Topical ethyl chloride fine spray. Does it have any antimicrobial activity? Clin Radiol. 2006 Dec;61(12):1055-7. doi: 10.1016/j.crad.2006.07.009.
- Polishchuk D, Gehrmann R, Tan V. Skin sterility after application of ethyl chloride spray. J Bone Joint Surg Am. 2012 Jan 18;94(2):118-20. doi: 10.2106/JBJS.K.00229.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2009
Primary Completion (Actual)
October 1, 2010
Study Completion (Actual)
October 1, 2010
Study Registration Dates
First Submitted
February 8, 2011
First Submitted That Met QC Criteria
February 9, 2011
First Posted (Estimate)
February 10, 2011
Study Record Updates
Last Update Posted (Estimate)
February 10, 2011
Last Update Submitted That Met QC Criteria
February 9, 2011
Last Verified
February 1, 2011
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 0120080090
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.