Skin Sterility After Use of Ethyl-chloride Spray.NCT01292850
Skin Sterility After Ethyl-Chloride Spray
An observational study of Skin Sterility After Use of Ethyl-chloride Spray., run by University of Medicine and Dentistry of New Jersey at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Skin Sterility After Use of Ethyl-chloride Spray.
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2009to Oct 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Healty adult (18-85) volunteers
Who may be able to join
- age -- 18-85
- healthy skin at shoulder and knee area
Who cannot join
- allergy to ethyl-chloride
- skin lesions at shoulder or knee
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Keywords
- Topical, Skin, sterility, ethylchloride, ethyl, chloride, spray
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Healthy Volunteers | 15 healthy volunteers were recruited |
What is being measured
The primary outcome is the main question the study is designed to answer.
culture positivity
Cultures before and after Ethyl-Chloride spray are compared to see if there is any difference.
Measured: 5 days
Secondary outcomes (1)
Native skin flora
Cultures of skin prior to skin prep are taken to define to native flora at the shoulder and knee area.
Measured: 5days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2011 (estimated)
- Study startFeb 2009
- Primary completionOct 2010
- Study completionOct 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Skin Sterility After Use of Ethyl-chloride Spray.Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Medicine and Dentistry of New Jersey
- Sponsor type
- University, hospital or other
- Investigators
- Robin M Gehrmann, MD, Principal investigator, Rutgers, The State University of New Jersey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01292850
- Sponsor's protocol ID
- 0120080090
- Status last verified
- Feb 2011
- First submitted
- 8 Feb 2011
- Last updated
- 10 Feb 2011
- Results posted
- No
- Data monitoring committee
- No
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. doi: 10.1007/BF03006485.
PubMed 2208537Cohen 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.
PubMed 9374583Soueid 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.
PubMed 17572521Weiss 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.
PubMed 20142994Burney 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.
PubMed 17097428Saltzman 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.
PubMed 19651954Polishchuk 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.
PubMed 22257997
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Skin Sterility After Ethyl-Chloride Spray
- ClinicalTrials.gov ID
- NCT01292850
- Acronym / sponsor ID
- 0120080090
- Keywords
- Topical, Skin, sterility, ethylchloride, ethyl, chloride, spray
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- University of Medicine and Dentistry of New JerseyUniversity, hospital or other
- Study start
- Feb 2009
- Primary completion
- Oct 2010 (actual)
- Study completion
- Oct 2010 (actual)
- First posted
- 10 Feb 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy Volunteers | – | –15 healthy volunteers were recruited |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healty adult (18-85) volunteers
Key inclusion criteria (2 listed)
- age -- 18-85
- healthy skin at shoulder and knee area
Key exclusion criteria (2 listed)
- allergy to ethyl-chloride
- skin lesions at shoulder or knee
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
culture positivity
Time frame: 5 days
Cultures before and after Ethyl-Chloride spray are compared to see if there is any difference.
1 secondary outcome
Native skin flora
Time frame: 5days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2011.
- Background: PubMed 2208537Armstrong 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.
- Background: PubMed 9374583Cohen 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.
- Background: PubMed 17572521Soueid 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.
- Background: PubMed 20142994Weiss 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.
- Background: PubMed 17097428Burney 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.
- Background: PubMed 19651954Saltzman 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.
- Derived from this study: PubMed 22257997Polishchuk 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robin M Gehrmann, MD principal investigator
Rutgers, The State University of New Jersey
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Skin Sterility After Use of Ethyl-chloride Spray., run by University of Medicine and Dentistry of New Jersey at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Feb 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
culture positivity (time frame: 5 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01292850, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2011.