SprayPhase 4NCT04207710
Safety of Gebauer's Pain Ease and Gebauer's Ethyl Chloride
A Phase 4 study testing Gebauer's Pain Ease Top Aerosol Mist Spray and Gebauer's Ethyl Chloride in people with Spray and Pain, run by Henry Ford Health System at 1 site in United States.
Trial summary
This study aims to determine if Gebauer's Pain Ease or Gebauer's Ethyl Chloride topical anesthetic sprays are safe for use as numbing agents prior to placing epidurals and arterial lines, based on whether they introduce increased microbial growth after application to skin. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Spray, Pain, Safety Issues
- What is being tested?
- Gebauer's Pain Ease Top Aerosol Mist Spray and Gebauer's Ethyl Chloride
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Jan 2021to 25 Feb 2022
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Henry Ford employees
Who cannot join
- People with infections at the site of prep
- People with history of hypersensitivity to numbing sprays or chloraprep
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study to Determine the Safety of Gebauer's Ethyl Chloride and Gebauer's Pain Ease Sprays When Used Following ChloraPrep for Invasive Procedures
This study aims to determine if Gebauer's Pain Ease or Gebauer's Ethyl Chloride topical anesthetic sprays are safe for use as numbing agents prior to placing epidurals and arterial lines, based on whether they introduce increased microbial growth after application to skin. Due to the recent national shortage of lidocaine, we hope to find a suitable alternative to lidocaine for topical analgesia when placing arterial lines and epidurals. Our hypothesis is that the sprays will not affect the sterility of the area. We will compare microbial growth from three subsequent swabs taken from a single area of skin on the wrist and lower back: one with no treatment, the second after treatment with ChloraPrep, and the third after applying one of the numbing sprays. If there is significantly higher growth in the swabs containing the topical anesthetic spray versus the ChloraPrep alone, this will indicate that the sprays introduce microbes to the sites of skin.
Read the detailed description
The purpose of this study is to determine whether Gebauer's Pain Ease and Ethyl Chloride topical anesthetic sprays are safe for application on the areas of skin where epidurals (lower back) and arterial lines (wrist) are placed, based on whether they introduce microbial growth to these areas. The investigators will compare microbial growth by swabbing both of these skin sites following: 1) no treatment 2) ChloraPrep treatment and 3) ChloraPrep plus numbing spray (Ethyl Chloride or Pain Ease) treatment. The cultures will then be incubated to test for anaerobic bacteria, aerobic bacteria, and mold growth. The microbial growth will be compared between the three treatment groups based on the number of colony forming units present.
Funding for the project will be from the manufacturer of the numbing sprays, Gebauer Company.
Based on power analysis, for each of the numbing sprays, a total of 72 subjects must be enrolled, with 6 swabs taken per subject (untreated, ChloraPrep, and topical anesthetic spray samples will be taken from both the wrist and lower back of each subject). A sample size of 72 pairs achieves 80 % power to detect an odds ratio of 24 using a two-sided McNemar test with a significance level of 0.05.
- Conditions
- Spray, Pain, Safety Issues
- Being tested
- Gebauer's Pain Ease Top Aerosol Mist Spray, Gebauer's Ethyl Chloride
- Keywords
- Pain Ease, Ethyl Chloride, Safety, Topical anesthetic, ChloraPrep, Topical refrigerant, Microbial growth
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gebauer's Pain Ease Top Aerosol Mist SprayDrug
Also called Pain Ease
Topical refrigerant spray
Gebauer's Ethyl ChlorideDrug
Also called Ethyl Chloride
Topical refrigerant spray
| Study group | Role | What they receive |
|---|---|---|
| Microbial growth on wrist after application of Gebauer's Ethyl Chloride | Experimental | An area of skin on the wrist will be swabbed before and after Chloraprep application, and then each area will be swabbed again after application of Gebauer's Ethyl Chloride topical refrigerant spray. The bacterial growth prior to and after numbing spray application will be evaluated, based on the number of colony forming units that are present. Receives: Drug: Gebauer's Ethyl Chloride |
| Microbial growth on lower back after application of Gebauer's Ethyl Chloride | Experimental | An area of skin on the lower back will be swabbed before and after Chloraprep application, and then each area will be swabbed again after application of Gebauer's Ethyl Chloride topical refrigerant spray. The bacterial growth prior to and after numbing spray application will be evaluated, based on the number of colony forming units that are present. Receives: Drug: Gebauer's Ethyl Chloride |
| Microbial growth on wrist after application of Gebauer's Pain Ease | Experimental | An area of skin on the wrist will be swabbed before and after Chloraprep application, and then each area will be swabbed again after application of Gebauer's Pain Ease topical refrigerant spray. The bacterial growth prior to and after numbing spray application will be evaluated, based on the number of colony forming units that are present. Receives: Drug: Gebauer's Pain Ease Top Aerosol Mist Spray |
| Microbial growth on lower back after application of Gebauer's Pain Ease | Experimental | An area of skin on the lower back will be swabbed before and after Chloraprep application, and then each area will be swabbed again after application of Gebauer's Pain Ease topical refrigerant spray. The bacterial growth prior to and after numbing spray application will be evaluated, based on the number of colony forming units that are present. Receives: Drug: Gebauer's Pain Ease Top Aerosol Mist Spray |
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence of Microbial Growth (1+ CFU)
Number of skin samples that were positive for bacterial growth following treatment with ChloraPrep and then application of a topical refrigerant spray (Gebauer's Ethyl Chloride or Gebauer's Pain Ease), when the area was swabbed and cultured for three days. A sample was considered positive if 1 or more colony forming units were present per swab.
Measured: Skin samples were swabbed within 20 seconds of Ethyl Chloride or Pain Ease application, and then swabs were cultured for 3 days before checking for the presence of CFU.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2019
- Study start26 Jan 2021
- Primary completion25 Feb 2022
- Study completion25 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for SprayStudies of the same condition, open and under way.
- More trials run by Henry Ford Health SystemThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 72 participants will have an area of skin on the wrist and lower back swabbed three times each. First, the untreated patch of skin will be swabbed, then it will be treated with ChloraPep and swabbed, then Pain Ease spray will be applied and the area will be swabbed again. The same process will be performed using Ethyl Chloride spray instead of Pain Ease on the opposite wrist and adjacent area on the lower back. The bacterial growth will be compared amongst the different treatments, based on the number of colony forming units that are present.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Henry Ford Health System
- Sponsor type
- University, hospital or other
- Collaborators
- Gebauer Company
- Responsible party
- Principal investigator, Katherine Nowak, PhD, Henry Ford Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04207710
- Sponsor's protocol ID
- 12932
- Status last verified
- Mar 2024
- First submitted
- 19 Dec 2019
- Last updated
- 4 Mar 2024
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Mlynek K, Lyahn H, Richards B, Schleicher W, Bassiri Gharb B, Procop G, Tuohy M, Zins J. Skin Sterility After Application of a Vapocoolant Spray Part 2. Aesthetic Plast Surg. 2015 Aug;39(4):597-601. doi: 10.1007/s00266-015-0509-5. Epub 2015 Jun 5.
PubMed 26044395Polishchuk 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 4 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study to Determine the Safety of Gebauer's Ethyl Chloride and Gebauer's Pain Ease Sprays When Used Following ChloraPrep for Invasive Procedures
- ClinicalTrials.gov ID
- NCT04207710
- Acronym / sponsor ID
- 12932
- Conditions
- Spray, Pain, Safety Issues
- Keywords
- Pain Ease, Ethyl Chloride, Safety, Topical anesthetic, ChloraPrep, Topical refrigerant, Microbial growth
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Henry Ford Health SystemUniversity, hospital or other
- Collaborators
- Gebauer Company
- Study start
- 26 Jan 2021 (actual)
- Primary completion
- 25 Feb 2022 (actual)
- Study completion
- 25 Feb 2022 (actual)
- First posted
- 23 Dec 2019 (actual)
- Results
- Posted 4 Mar 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to determine if Gebauer's Pain Ease or Gebauer's Ethyl Chloride topical anesthetic sprays are safe for use as numbing agents prior to placing epidurals and arterial lines, based on whether they introduce increased microbial growth after application to skin. Due to the recent national shortage of lidocaine, we hope to find a suitable alternative to lidocaine for topical analgesia when placing arterial lines and epidurals. Our hypothesis is that the sprays will not affect the sterility of the area. We will compare microbial growth from three subsequent swabs taken from a single area of skin on the wrist and lower back: one with no treatment, the second after treatment with ChloraPrep, and the third after applying one of the numbing sprays. If there is significantly higher growth in the swabs containing the topical anesthetic spray versus the ChloraPrep alone, this will indicate that the sprays introduce microbes to the sites of skin.
Detailed description
The purpose of this study is to determine whether Gebauer's Pain Ease and Ethyl Chloride topical anesthetic sprays are safe for application on the areas of skin where epidurals (lower back) and arterial lines (wrist) are placed, based on whether they introduce microbial growth to these areas. The investigators will compare microbial growth by swabbing both of these skin sites following: 1) no treatment 2) ChloraPrep treatment and 3) ChloraPrep plus numbing spray (Ethyl Chloride or Pain Ease) treatment. The cultures will then be incubated to test for anaerobic bacteria, aerobic bacteria, and mold growth. The microbial growth will be compared between the three treatment groups based on the number of colony forming units present.
Funding for the project will be from the manufacturer of the numbing sprays, Gebauer Company.
Based on power analysis, for each of the numbing sprays, a total of 72 subjects must be enrolled, with 6 swabs taken per subject (untreated, ChloraPrep, and topical anesthetic spray samples will be taken from both the wrist and lower back of each subject). A sample size of 72 pairs achieves 80 % power to detect an odds ratio of 24 using a two-sided McNemar test with a significance level of 0.05.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
- Model description
- 72 participants will have an area of skin on the wrist and lower back swabbed three times each. First, the untreated patch of skin will be swabbed, then it will be treated with ChloraPep and swabbed, then Pain Ease spray will be applied and the area will be swabbed again. The same process will be performed using Ethyl Chloride spray instead of Pain Ease on the opposite wrist and adjacent area on the lower back. The bacterial growth will be compared amongst the different treatments, based on the number of colony forming units that are present.
| Arm | Type | Receives |
|---|---|---|
| Microbial growth on wrist after application of Gebauer's Ethyl Chloride | Experimental | Drug: Gebauer's Ethyl ChlorideAn area of skin on the wrist will be swabbed before and after Chloraprep application, and then each area will be swabbed again after application of Gebauer's Ethyl Chloride topical refrigerant spray. The bacterial growth prior to and after numbing spray application will be evaluated, based on the number of colony forming units that are present. |
| Microbial growth on lower back after application of Gebauer's Ethyl Chloride | Experimental | Drug: Gebauer's Ethyl ChlorideAn area of skin on the lower back will be swabbed before and after Chloraprep application, and then each area will be swabbed again after application of Gebauer's Ethyl Chloride topical refrigerant spray. The bacterial growth prior to and after numbing spray application will be evaluated, based on the number of colony forming units that are present. |
| Microbial growth on wrist after application of Gebauer's Pain Ease | Experimental | Drug: Gebauer's Pain Ease Top Aerosol Mist SprayAn area of skin on the wrist will be swabbed before and after Chloraprep application, and then each area will be swabbed again after application of Gebauer's Pain Ease topical refrigerant spray. The bacterial growth prior to and after numbing spray application will be evaluated, based on the number of colony forming units that are present. |
| Microbial growth on lower back after application of Gebauer's Pain Ease | Experimental | Drug: Gebauer's Pain Ease Top Aerosol Mist SprayAn area of skin on the lower back will be swabbed before and after Chloraprep application, and then each area will be swabbed again after application of Gebauer's Pain Ease topical refrigerant spray. The bacterial growth prior to and after numbing spray application will be evaluated, based on the number of colony forming units that are present. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Henry Ford employees
Key exclusion criteria (2 listed)
- People with infections at the site of prep
- People with history of hypersensitivity to numbing sprays or chloraprep
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gebauer's Pain Ease Top Aerosol Mist SprayAlso: Pain EaseTopical refrigerant spray | Drug | Microbial growth on lower back after application of Gebauer's Pain Ease, Microbial growth on wrist after application of Gebauer's Pain Ease |
| Gebauer's Ethyl ChlorideAlso: Ethyl ChlorideTopical refrigerant spray | Drug | Microbial growth on lower back after application of Gebauer's Ethyl Chloride, Microbial growth on wrist after application of Gebauer's Ethyl Chloride |
Primary outcome
Presence of Microbial Growth (1+ CFU)
Time frame: Skin samples were swabbed within 20 seconds of Ethyl Chloride or Pain Ease application, and then swabs were cultured for 3 days before checking for the presence of CFU.
Number of skin samples that were positive for bacterial growth following treatment with ChloraPrep and then application of a topical refrigerant spray (Gebauer's Ethyl Chloride or Gebauer's Pain Ease), when the area was swabbed and cultured for three days. A sample was considered positive if 1 or more colony forming units were present per swab.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 26044395Mlynek K, Lyahn H, Richards B, Schleicher W, Bassiri Gharb B, Procop G, Tuohy M, Zins J. Skin Sterility After Application of a Vapocoolant Spray Part 2. Aesthetic Plast Surg. 2015 Aug;39(4):597-601. doi: 10.1007/s00266-015-0509-5. Epub 2015 Jun 5.
- Background: 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.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Gebauer's Pain Ease Top Aerosol Mist Spray and Gebauer's Ethyl Chloride in people with Spray and Pain, run by Henry Ford Health System 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 1 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 4 Mar 2024. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 4 Mar 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Presence of Microbial Growth (1+ CFU) (time frame: Skin samples were swabbed within 20 seconds of Ethyl Chloride or Pain Ease application, and then swabs were cultured for 3 days before checking for the presence of CFU.). 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 NCT04207710, which also lists 2 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 4 Mar 2024.