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| Name | Class |
|---|---|
| Gebauer Company | NETWORK |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
|
| 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. |
|
| Microbial growth on lower back after application of Gebauer's Pain Ease | Experimental |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gebauer's Pain Ease Top Aerosol Mist Spray | Drug | Topical refrigerant spray |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Henry Ford Hospital | Detroit | Michigan | 48202 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26044395 | Background | 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. | |
| 22257997 | Background | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Microbial Growth on Wrists and Lower After Application of Gebauer's Ethyl Chloride or Pain Ease. | An area of skin on the wrist swabbed before and after Chloraprep application, and then each area swabbed again after application of Gebauer's Ethyl Chloride topical refrigerant spray. Bacterial growth prior to and after numbing spray application evaluated, based on number of colony forming units present. An area of skin on the lower back of an individual's skin swabbed before and after Chloraprep application, and then each area swabbed again after application of Gebauer's Ethyl Chloride topical refrigerant spray. Bacterial growth prior to and after spray application evaluated, based on number of colony forming units present. An area of skin on the wrist swabbed before and after Chloraprep application, and then swabbed again after application of Gebauer's Pain Ease topical refrigerant spray. Bacterial growth prior to and after spray application evaluated, based on number of colony forming units present. An area of skin on the lower back swabbed before and after Chloraprep application, and then after application of Gebauer's Pain Ease topical refrigerant spray. Bacterial growth prior to and after spray application evaluated, based on number of colony forming units present. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Microbial Growth on Skin After Application of Gebauer's Ethyl Chloride or Pain Ease | In a split-person design, each subject had four areas of skin swabbed as follows:
The bacterial growth prior to and after numbing spray application were evaluated based on the number of colony forming units that were present. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Age information was not collected as this was irrelevant to the study aims. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Number | Number of samples with 1+ CFU | 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. |
|
During swabbing of skin (5-15 minutes)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Microbial Growth on Wrist After Application of Gebauer's Ethyl Chloride | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director of Research, Department of Anesthesiology | Henry Ford Health | 313-771-7128 | knowak2@hfhs.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 19, 2019 | Jun 16, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C552522 | pain ease refrigerant |
| D005018 | Ethyl Chloride |
| ID | Term |
|---|---|
| D006843 | Hydrocarbons, Chlorinated |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
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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.
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The microbiology lab staff culturing and analyzing the samples for microbial growth will not know what type of treatment each sample received. Each sample will only be labelled with a numerical string. The research staff will have a spreadsheet to determine which numerical string corresponds with which treatment.
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.
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|
| Gebauer's Ethyl Chloride | Drug | Topical refrigerant spray |
|
|
| Mean |
| Standard Deviation |
| years |
|
| Sex: Female, Male | Gender information was not collected for this study as it was not relevant to the study aims. | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| OG001 |
| Lower Back, Gebauer's Ethyl Chloride |
Skin on lower back swabbed before treatment, then after sterilization with Chloraprep, then after application of Gebauer's Ethyl Chloride topical refrigerant spray. Samples cultured and evaluated for positive bacterial growth. |
| OG002 | Wrist, Gebauer's Pain Ease | Wrist swabbed before treatment, after sterilization with Chloraprep, then after application of Gebauer's Pain Ease. Samples cultured and evaluated for positive bacterial growth. |
| OG003 | Lower Back, Gebauer's Pain Ease | Lower back swabbed before treatment, after Chloraprep, then after application of Gebauer's Pain Ease. Samples cultured and evaluated for positive bacterial growth. |
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|
|
| 0 |
| 72 |
| 0 |
| 72 |
| 0 |
| 72 |
| EG001 | Microbial Growth on Lower Back After Application of Gebauer's Ethyl Chloride | An area of skin on the lower back of an individual's skin 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 spray application will be evaluated, based on the number of colony forming units that are present. | 0 | 72 | 0 | 72 | 0 | 72 |
| EG002 | Microbial Growth on Wrist After Application of Gebauer's Pain Ease | An area of skin on the wrist of an individual's skin 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 spray application will be evaluated, based on the number of colony forming units that are present. | 0 | 72 | 0 | 72 | 0 | 72 |
| EG003 | Microbial Growth on Lower Back After Application of Gebauer's Pain Ease | An area of skin on the lower back of an individual's skin 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 spray application will be evaluated, based on the number of colony forming units that are present. | 0 | 72 | 0 | 72 | 0 | 72 |
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