Ignite Creation Date:
2025-12-24 @ 5:18 PM
Ignite Modification Date:
2025-12-28 @ 12:56 AM
Study NCT ID:
NCT01292850
Status:
COMPLETED
Last Update Posted:
2011-02-10
First Post:
2011-02-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Skin Sterility After Ethyl-Chloride Spray
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007246', 'term': 'Infertility'}], 'ancestors': [{'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 15}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-02', 'completionDateStruct': {'date': '2010-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-02-09', 'studyFirstSubmitDate': '2011-02-08', 'studyFirstSubmitQcDate': '2011-02-09', 'lastUpdatePostDateStruct': {'date': '2011-02-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-02-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'culture positivity', 'timeFrame': '5 days', 'description': 'Cultures before and after Ethyl-Chloride spray are compared to see if there is any difference.'}], 'secondaryOutcomes': [{'measure': 'Native skin flora', 'timeFrame': '5days', 'description': 'Cultures of skin prior to skin prep are taken to define to native flora at the shoulder and knee area.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Topical', 'Skin', 'sterility', 'ethylchloride', 'ethyl', 'chloride', 'spray'], 'conditions': ['Skin Sterility After Use of Ethyl-chloride Spray.']}, 'referencesModule': {'references': [{'pmid': '2208537', 'type': 'BACKGROUND', '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.'}, {'pmid': '9374583', 'type': 'BACKGROUND', '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.'}, {'pmid': '17572521', 'type': 'BACKGROUND', '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.'}, {'pmid': '20142994', 'type': 'BACKGROUND', '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.'}, {'pmid': '17097428', 'type': 'BACKGROUND', '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.'}, {'pmid': '19651954', 'type': 'BACKGROUND', '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.'}, {'pmid': '22257997', 'type': 'DERIVED', '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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Healty adult (18-85) volunteers', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age -- 18-85\n* healthy skin at shoulder and knee area\n\nExclusion Criteria:\n\n* allergy to ethyl-chloride\n* skin lesions at shoulder or knee'}, 'identificationModule': {'nctId': 'NCT01292850', 'briefTitle': 'Skin Sterility After Ethyl-Chloride Spray', 'organization': {'class': 'OTHER', 'fullName': 'Rutgers, The State University of New Jersey'}, 'officialTitle': 'Skin Sterility After Ethyl-Chloride Spray', 'orgStudyIdInfo': {'id': '0120080090'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Healthy Volunteers', 'description': '15 healthy volunteers were recruited'}]}, 'contactsLocationsModule': {'locations': [{'zip': '07103', 'city': 'Newark', 'state': 'New Jersey', 'country': 'United States', 'facility': 'UMDNJ UH', 'geoPoint': {'lat': 40.73566, 'lon': -74.17237}}], 'overallOfficials': [{'name': 'Robin M Gehrmann, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Rutgers, The State University of New Jersey'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Medicine and Dentistry of New Jersey', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Robin Gehrmann, M.D. Assistant Professor Department of Orthopaedics, Chief of Sports Medicine', 'oldOrganization': 'New Jersey Medical School, UMDNJ'}}}}