Ignite Creation Date:
2024-05-06 @ 2:03 PM
Last Modification Date:
2024-10-26 @ 1:24 PM
Study NCT ID:
NCT04207710
Status:
COMPLETED
Last Update Posted:
2024-03-04
First Post:
2019-12-19
Brief Title:
Safety of Gebauers Pain Ease and Gebauers Ethyl Chloride
Sponsor:
Henry Ford Health System
Organization:
Henry Ford Health System
Study Overview
Official Title:
Study to Determine the Safety of Gebauers Ethyl Chloride and Gebauers Pain Ease Sprays When Used Following ChloraPrep for Invasive Procedures
Status:
COMPLETED
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study aims to determine if Gebauers Pain Ease or Gebauers 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 Gebauers 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 005
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 005
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None