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Microbial growth on wrist after application of Gebauer's Ethyl Chloride for Asthma

Phase 4

Waitlist Available

Research Sponsored by Henry Ford Health System

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

* Henry Ford employees

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 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.

Awards & highlights

Drug Has Already Been Approved

No Placebo-Only Group

Pivotal Trial

Summary

This trial is testing whether two numbing agents are safe to use before placing epidurals or arterial lines. One numbing agent is Gebauer's Pain Ease spray, and the other is Gebauer's Ethyl Chloride topical anesthetic spray. The trial will compare the amount of microbial growth on three different areas of skin: one with no treatment, one with ChloraPrep, and one with one of the numbing agents. If the numbing agent significantly increases the amount of microbial growth, this will indicate that the numbing agent is introducing microbes to the site and is not safe to use.

Eligible Conditions

Asthma
Pain
Safety Concerns

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 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.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~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.

This trial's timeline: 3 weeks for screening, Varies for treatment, and 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. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Presence of Microbial Growth (1+ CFU)

Awards & Highlights

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

4Treatment groups

Experimental Treatment

Group I: Microbial growth on wrist after application of Gebauer's Pain EaseExperimental Treatment1 Intervention

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.

Group II: Microbial growth on wrist after application of Gebauer's Ethyl ChlorideExperimental Treatment1 Intervention

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.

Group III: Microbial growth on lower back after application of Gebauer's Pain EaseExperimental Treatment1 Intervention

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.

Group IV: Microbial growth on lower back after application of Gebauer's Ethyl ChlorideExperimental Treatment1 Intervention

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Gebauer's Ethyl Chloride

2021

Completed Phase 4

~80

Gebauer's Pain Ease Top Aerosol Mist Spray

2021

Completed Phase 4

~80