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| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
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A novel hydrogen peroxide-generating electrochemical bandage for wound infection treatment and prevention, and wound healing has been developed. The purpose of this research is to gather information on the safety and to confirm lack of toxicity of small hydrogen peroxide-generating e-bandages on normal human skin.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| e-Bandages 3 hours | Experimental | Four subjects will wear the e-Bandage on their skin for 24 hours, with active polarization for 3 hours. |
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| e-Bandages 6 hours | Experimental | Four subjects will wear the e-Bandage on their skin for 24 hours, with active polarization for 6 hours. |
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| e-Bandages 12 hours | Experimental | Four subjects will wear the e-Bandage on their skin for 24 hours, with active polarization for 12 hours. |
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| e-Bandages 24 hours | Experimental | Four subjects will wear the e-Bandage on their skin for 24 hours, with active polarization for 24 hours. |
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| Control Group | Experimental | Four subjects will wear the e-Bandage on their skin for 24 hours, with no active polarization. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| e-Bandages | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| e-Bandage Discomfort | Self-report discomfort with the e-Bandage, graded on a scale of 1-4, with 1 being no reaction, 2 mild reaction, 3 moderate reaction, 4 severe reaction. | Approximately 3 - 24 hours |
| Skin irritation/dermatitis | Skin redness or swelling, graded on a scale of 1-4, with 1 being no reaction, 2 mild reaction, 3 moderate reaction, 4 severe reaction. | Approximately 3 - 24 hours |
| Allergic Reaction | Local/systemic allergic reaction to the e-Bandage, graded on a scale of 1-4, with 1 being no reaction, 2 mild reaction, 3 moderate reaction, 4 severe reaction. | Approximately 3 - 24 hours |
| Skin Discoloration | Skin discoloration from the e-Bandage, graded on a scale of 1-4, with 1 being no reaction, 2 mild reaction, 3 moderate reaction, 4 severe reaction. | Approximately 3 - 24 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Robin Patel, MD | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic Minnesota | Rochester | Minnesota | 55905 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41168214 | Derived | 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. |
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