Clinical trial NCT01292850: Skin Sterility After Ethyl-Chloride Spray
Official title: Skin Sterility After Ethyl-Chloride Spray
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Skin Sterility After Use of Ethyl-chloride Spray.
Keywords: Topical
Skin
sterility
ethylchloride
ethyl
chloride
spray
Lead sponsor: Rutgers, The State University of New Jersey
Sponsor class: OTHER
First posted: 2011-02-10
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healty adult (18-85) volunteers

Brief summary: 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.

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 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

Primary outcomes:
measure: culture positivity
timeFrame: 5 days
Secondary outcomes:
measure: Native skin flora
timeFrame: 5days
Other outcomes:
Locations:
city: Newark
country: United States
facility: UMDNJ UH
state: New Jersey
Study officials:
affiliation: Rutgers, The State University of New Jersey
name: Robin M Gehrmann, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.