Skin Sterility After Ethyl-Chloride Spray

This study has been completed.

Sponsor:

Information provided by:

University of Medicine and Dentistry New Jersey

ClinicalTrials.gov Identifier:

NCT01292850

First received: February 8, 2011

Last updated: February 9, 2011

Last verified: February 2011

History of Changes

Tracking Information

First Received Date ^ICMJE

February 8, 2011

Last Updated Date

February 9, 2011

Start Date ^ICMJE

February 2009

Primary Completion Date

October 2010 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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.

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01292850 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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.

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Skin Sterility After Ethyl-Chloride Spray

Official Title ^ICMJE

Skin Sterility After Ethyl-Chloride Spray

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.

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Time Perspective: Prospective

Target Follow-Up Duration

Not Provided

Biospecimen

Not Provided

Sampling Method

Non-Probability Sample

Study Population

Healty adult (18-85) volunteers

Condition ^ICMJE

Skin Sterility After Use of Ethyl-chloride Spray.

Intervention ^ICMJE

Not Provided

Study Group/Cohort (s)

Healthy Volunteers

15 healthy volunteers were recruited

Publications *

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.
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.
Soueid A, Richard B. Ethyl chloride as a cryoanalgesic in pediatrics for venipuncture. Pediatr Emerg Care. 2007 Jun;23(6):380-3.
Weiss JE, Uribe AG, Malleson PN, Kimura Y. Anesthesia for intra-articular corticosteroid injections in juvenile idiopathic arthritis: A survey of pediatric rheumatologists. Pediatric Rheumatology Online J. 2010 Jan 13;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.
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.
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.

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

October 2010

Primary Completion Date

October 2010 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

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

Exclusion Criteria:

allergy to ethyl-chloride
skin lesions at shoulder or knee

Gender

Both

Ages

18 Years to 85 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT01292850

Other Study ID Numbers ^ICMJE

0120080090

Has Data Monitoring Committee

Responsible Party

Robin Gehrmann, M.D. Assistant Professor Department of Orthopaedics, Chief of Sports Medicine, New Jersey Medical School, UMDNJ

Study Sponsor ^ICMJE

University of Medicine and Dentistry New Jersey

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Robin M Gehrmann, MD

University of Medicine and Dentistry New Jersey

Information Provided By

University of Medicine and Dentistry New Jersey

Verification Date

February 2011

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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