Skin Sterility After Ethyl-Chloride Spray

Skin Sterility After Use of Ethyl-chloride Spray. Clinical Trial

Official title:

Skin Sterility After Ethyl-Chloride Spray

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01292850
• Other study ID #: 0120080090
• Status: Completed
• Phase: N/A
• First received: February 8, 2011
• Last updated: February 9, 2011
• Start date: February 2009
• Est. completion date: October 2010

Study information

• Verified date: February 2011
• Source: Rutgers, The State University of New Jersey
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: October 2010
• Est. primary completion date: October 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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 Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Infertility
• Skin Sterility After Use of Ethyl-chloride Spray.

Locations

Country	Name	City	State
United States	UMDNJ UH	Newark	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
University of Medicine and Dentistry of New Jersey

Country where clinical trial is conducted

United States, 

References & Publications (6)

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. — View 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. — View 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. — View 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. — View Citation

Soueid A, Richard B. Ethyl chloride as a cryoanalgesic in pediatrics for venipuncture. Pediatr Emerg Care. 2007 Jun;23(6):380-3. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	culture positivity	Cultures before and after Ethyl-Chloride spray are compared to see if there is any difference.	5 days	No
Secondary	Native skin flora	Cultures of skin prior to skin prep are taken to define to native flora at the shoulder and knee area.	5days	No