A Study of Hydrogen Peroxide-Generating E-bandage Safety
NCT ID: NCT05940207
Last Updated: 2026-01-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
40 participants
INTERVENTIONAL
2024-03-27
2029-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
OTHER
NONE
Study Groups
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e-Bandages 3 hours
Four subjects will wear the e-Bandage on their skin for 24 hours, with active polarization for 3 hours.
e-Bandages
A hydrogen-peroxide generating e-bandage for wound infection and treatment and prevention. Each e-bandage is composed of three electrodes - a working, a counter, and a reference electrode. Cotton fabric physically separates electrodes. Constant (regulated) generation of low-concentrations of hydrogen peroxide happens on the working electrode, which is in contact with the skin covered with a hydrogel layer.
e-Bandages 6 hours
Four subjects will wear the e-Bandage on their skin for 24 hours, with active polarization for 6 hours.
e-Bandages
A hydrogen-peroxide generating e-bandage for wound infection and treatment and prevention. Each e-bandage is composed of three electrodes - a working, a counter, and a reference electrode. Cotton fabric physically separates electrodes. Constant (regulated) generation of low-concentrations of hydrogen peroxide happens on the working electrode, which is in contact with the skin covered with a hydrogel layer.
e-Bandages 12 hours
Four subjects will wear the e-Bandage on their skin for 24 hours, with active polarization for 12 hours.
e-Bandages
A hydrogen-peroxide generating e-bandage for wound infection and treatment and prevention. Each e-bandage is composed of three electrodes - a working, a counter, and a reference electrode. Cotton fabric physically separates electrodes. Constant (regulated) generation of low-concentrations of hydrogen peroxide happens on the working electrode, which is in contact with the skin covered with a hydrogel layer.
e-Bandages 24 hours
Four subjects will wear the e-Bandage on their skin for 24 hours, with active polarization for 24 hours.
e-Bandages
A hydrogen-peroxide generating e-bandage for wound infection and treatment and prevention. Each e-bandage is composed of three electrodes - a working, a counter, and a reference electrode. Cotton fabric physically separates electrodes. Constant (regulated) generation of low-concentrations of hydrogen peroxide happens on the working electrode, which is in contact with the skin covered with a hydrogel layer.
Control Group
Four subjects will wear the e-Bandage on their skin for 24 hours, with no active polarization.
e-Bandages
A hydrogen-peroxide generating e-bandage for wound infection and treatment and prevention. Each e-bandage is composed of three electrodes - a working, a counter, and a reference electrode. Cotton fabric physically separates electrodes. Constant (regulated) generation of low-concentrations of hydrogen peroxide happens on the working electrode, which is in contact with the skin covered with a hydrogel layer.
Interventions
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e-Bandages
A hydrogen-peroxide generating e-bandage for wound infection and treatment and prevention. Each e-bandage is composed of three electrodes - a working, a counter, and a reference electrode. Cotton fabric physically separates electrodes. Constant (regulated) generation of low-concentrations of hydrogen peroxide happens on the working electrode, which is in contact with the skin covered with a hydrogel layer.
Eligibility Criteria
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Inclusion Criteria
* Intact skin on arms.
* Able to provide appropriate consent.
Exclusion Criteria
* Pregnancy.
* Children.
* Skin disease.
* Non-intact skin on arms.
18 Years
99 Years
ALL
Yes
Sponsors
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National Institutes of Health (NIH)
NIH
Mayo Clinic
OTHER
Responsible Party
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Robin Patel
Principal Investigator
Principal Investigators
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Robin Patel, MD
Role: PRINCIPAL_INVESTIGATOR
Mayo Clinic
Locations
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Mayo Clinic Minnesota
Rochester, Minnesota, United States
Countries
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References
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Kies PJ, Kim WJ, Fleming D, Bozyel I, Holtegaard S, Shrivastava S, Schwartz K, Schwieder S, Beyenal H, Patel R. Safety trial assessing 1.77 cm2 H2O2 producing electrochemical bandages on healthy human skin. Sci Rep. 2025 Oct 30;15(1):38074. doi: 10.1038/s41598-025-21803-y.
Other Identifiers
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23-003805
Identifier Type: -
Identifier Source: org_study_id
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