A Study of Hydrogen Peroxide-Generating E-bandage Safety

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05940207

Enrollment

Registered

2023-07-11

Start date

2024-03-27

Completion date

2029-05-01

Last updated

2026-01-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Brief 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.

Interventions

DEVICEe-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.

Study design

Allocation

NON_RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

OTHER

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 99 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
Skin Discoloration	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.
e-Bandage Discomfort	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.
Skin irritation/dermatitis	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.
Allergic Reaction	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.

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORRobin Patel, MD

Mayo Clinic

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026