A Study of Hydrogen Peroxide-Generating E-bandage Safety

NCT ID: NCT05940207

Last Updated: 2026-01-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-03-27

Study Completion Date

2029-05-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Healthy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

e-Bandages 3 hours

Four subjects will wear the e-Bandage on their skin for 24 hours, with active polarization for 3 hours.

Group Type EXPERIMENTAL

e-Bandages

Intervention Type 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.

e-Bandages 6 hours

Four subjects will wear the e-Bandage on their skin for 24 hours, with active polarization for 6 hours.

Group Type EXPERIMENTAL

e-Bandages

Intervention Type 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.

e-Bandages 12 hours

Four subjects will wear the e-Bandage on their skin for 24 hours, with active polarization for 12 hours.

Group Type EXPERIMENTAL

e-Bandages

Intervention Type 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.

e-Bandages 24 hours

Four subjects will wear the e-Bandage on their skin for 24 hours, with active polarization for 24 hours.

Group Type EXPERIMENTAL

e-Bandages

Intervention Type 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.

Control Group

Four subjects will wear the e-Bandage on their skin for 24 hours, with no active polarization.

Group Type EXPERIMENTAL

e-Bandages

Intervention Type 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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

National Institutes of Health (NIH)

NIH

Sponsor Role collaborator

Mayo Clinic

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Robin Patel

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Robin Patel, MD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Mayo Clinic Minnesota

Rochester, Minnesota, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 41168214 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

23-003805

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.