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NCT Number: NCT05940207

A Study of Hydrogen Peroxide-Generating E-bandage Safety

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Healthy

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic Minnesota

Rochester, Minnesota, 55905, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Collaborators

  • National Institutes of Health (NIH)

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2029
Study completion
2029
First posted
Jul 11, 2023
Registry last updated
Jan 26, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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