Clinical trial NCT04207710: Safety of Gebauer's Pain Ease and Gebauer's Ethyl Chloride
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Spray
Pain
Safety Issues
Keywords: Pain Ease
Ethyl Chloride
Safety
Topical anesthetic
ChloraPrep
Topical refrigerant
Microbial growth
Lead sponsor: Henry Ford Health System
Sponsor class: OTHER
Collaborators: name: Gebauer Company
First posted: 2019-12-23
Enrollment: 72
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Presence of Microbial Growth (1+ CFU)
timeFrame: 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.
Secondary outcomes:
Other outcomes:
Locations:
city: Detroit
country: United States
facility: Henry Ford Hospital
state: Michigan
Study officials:
References:
citation: 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.
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.