A Study of Hydrogen Peroxide-Generating E-bandage Safety
NCT05940207 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40
Last updated 2026-01-26
Summary
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.
Conditions
- Healthy
Interventions
- DEVICE
-
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.
Sponsors & Collaborators
-
National Institutes of Health (NIH)
collaborator NIH - lead OTHER
Principal Investigators
-
Robin Patel, MD · Mayo Clinic
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- OTHER
- Masking
- NONE
- Model
- SEQUENTIAL
Eligibility
- Min Age
- 18 Years
- Max Age
- 99 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2024-03-27
- Primary Completion
- 2029-05-31
- Completion
- 2029-05-31
- FDA Device
- Yes
Countries
- United States
Study Locations
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