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Safety of Gebauer's Pain Ease and Gebauer's Ethyl Chloride

Sponsor
Henry Ford Health System (Other)
Overall Status
Completed
CT.gov ID
NCT04207710
Collaborator
Gebauer Company (Other)
72
Enrollment
1
Location
2
Arms
13
Actual Duration (Months)
5.5
Patients Per Site Per Month

Study Details

Study Description

Brief 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. 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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Gebauer Pain Ease Top Aerosol Mist Spray
  • Drug: Gebauer Ethyl Chloride
 Phase 4

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

Study Type:
Interventional
Actual Enrollment :
72 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention 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.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 (Outcomes Assessor)
Masking Description:
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.
Primary Purpose:
Treatment
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
Actual Study Start Date :
Jan 26, 2021
Actual Primary Completion Date :
Feb 25, 2022
Actual Study Completion Date :
Feb 25, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Microbial growth after application of Pain Ease

An area of skin on the wrist and 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 Pain Ease numbing 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.

Drug: Gebauer Pain Ease Top Aerosol Mist Spray
Topical numbing spray
Other Names:
  • Pain Ease

    		•
    Experimental: Microbial growth after application of Ethyl Chloride

    An area of skin on the wrist and 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 Ethyl Chloride numbing 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.

    Drug: Gebauer Ethyl Chloride
    Topical numbing spray
    Other Names:
  • Ethyl Chloride

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Microbial growth [6-8 months]

      The number of colony forming units will be counted before and after application of numbing spray.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    • Henry Ford employees
    Exclusion Criteria:

    • People with infections at the site of prep

    • People with history of hypersensitivity to numbing sprays or chloraprep

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Henry Ford Hospital Detroit Michigan United States 48202

    Sponsors and Collaborators

    • Henry Ford Health System
    • Gebauer Company

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Ami Y Attali, DO, Principal Investigator, Henry Ford Health System
    ClinicalTrials.gov Identifier:
    NCT04207710
    Other Study ID Numbers:
    • 12932
    First Posted:
    Dec 23, 2019
    Last Update Posted:
    Mar 15, 2022
    Last Verified:
    Mar 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    Yes
    Keywords provided by Ami Y Attali, DO, Principal Investigator, Henry Ford Health System
    Pain Ease
    Ethyl Chloride
    Safety
    Topical anesthetic
    ChloraPrep
    Topical refrigerant
    Microbial growth
    Additional relevant MeSH terms:
    Ethyl Chloride

    Study Results

    No Results Posted as of Mar 15, 2022