Skin Sterility After Ethyl-Chloride Spray

NCT ID: NCT01292850

Last Updated: 2011-02-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

15 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-02-28

Study Completion Date

2010-10-31

Brief Summary

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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

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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.

Conditions

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Skin Sterility After Use of Ethyl-chloride Spray.

Study Design

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Study Time Perspective

PROSPECTIVE

Study Groups

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Healthy Volunteers

15 healthy volunteers were recruited

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* allergy to ethyl-chloride
* skin lesions at shoulder or knee
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Medicine and Dentistry of New Jersey

OTHER

Sponsor Role lead

Responsible Party

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New Jersey Medical School, UMDNJ

Principal Investigators

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Robin M Gehrmann, MD

Role: PRINCIPAL_INVESTIGATOR

Rutgers, The State University of New Jersey

Locations

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UMDNJ UH

Newark, New Jersey, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 2208537 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 9374583 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17572521 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20142994 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17097428 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19651954 (View on PubMed)

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.

Reference Type DERIVED
PMID: 22257997 (View on PubMed)

Other Identifiers

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0120080090

Identifier Type: -

Identifier Source: org_study_id

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