A Study of Hydrogen Peroxide-Generating E-bandage Safety

January 22, 2026 updated by: Robin Patel, Mayo Clinic

Safety Testing of Hydrogen Peroxide-Generating e-Bandage on Normal Human Skin

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic Minnesota

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Healthy.
  • Intact skin on arms.
  • Able to provide appropriate consent.

Exclusion Criteria:

  • Vulnerable study population.
  • Pregnancy.
  • Children.
  • Skin disease.
  • Non-intact skin on arms.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: e-Bandages 3 hours
Four subjects will wear the e-Bandage on their skin for 24 hours, with active polarization for 3 hours.
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.
Experimental: e-Bandages 6 hours
Four subjects will wear the e-Bandage on their skin for 24 hours, with active polarization for 6 hours.
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.
Experimental: e-Bandages 12 hours
Four subjects will wear the e-Bandage on their skin for 24 hours, with active polarization for 12 hours.
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.
Experimental: e-Bandages 24 hours
Four subjects will wear the e-Bandage on their skin for 24 hours, with active polarization for 24 hours.
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.
Experimental: Control Group
Four subjects will wear the e-Bandage on their skin for 24 hours, with no active polarization.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
e-Bandage Discomfort
Time Frame: Approximately 3 - 24 hours
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
Time Frame: Approximately 3 - 24 hours
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
Time Frame: Approximately 3 - 24 hours
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
Time Frame: Approximately 3 - 24 hours
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mayo Clinic

Collaborators

National Institutes of Health (NIH)

Investigators

  • Principal Investigator: Robin Patel, MD, Mayo Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 27, 2024

Primary Completion (Estimated)

May 1, 2029

Study Completion (Estimated)

May 1, 2029

Study Registration Dates

First Submitted

July 3, 2023

First Submitted That Met QC Criteria

July 3, 2023

First Posted (Actual)

July 11, 2023

Study Record Updates

Last Update Posted (Actual)

January 26, 2026

Last Update Submitted That Met QC Criteria

January 22, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

  • 23-003805

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Healthy

Clinical Trials on e-Bandages

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Ghana

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe