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Active, not recruitingNCT05940207Updated Jan 26, 2026

A Study of Hydrogen Peroxide-Generating E-bandage Safety

An interventional study of e-Bandages in Healthy, sponsored by Mayo Clinic. Active, not recruiting at 1 site in United States. Open to participants aged 18 Years to 99 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-01-26.

Sponsored by Mayo Clinic · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Non-randomized
Ages
18 Years to 99 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Healthy
03

In context

Lead sponsor

Mayo Clinic is the lead sponsor of 3,218 studies on the registry; 670 are open to participants now.

Of its 445 completed or terminated interventional studies of FDA-regulated products, 313 (70%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 99 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Vulnerable study population.
  • Pregnancy.
  • Children.
  • Skin disease.
  • Non-intact skin on arms.
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Non-randomized
Intervention model
Sequential assignment
Masking
None (open label)
Enrollment
40 participants (estimated)

Study arms

  • 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

  • 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

  • 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

  • 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

  • Experimental
    Control Group

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

    Device: e-Bandages

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.

06

What researchers measure

Primary outcomes

  1. e-Bandage Discomfort

    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.

    Time frame: Approximately 3 - 24 hours

  2. Skin irritation/dermatitis

    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.

    Time frame: Approximately 3 - 24 hours

  3. Allergic Reaction

    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.

    Time frame: Approximately 3 - 24 hours

  4. Skin Discoloration

    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.

    Time frame: Approximately 3 - 24 hours

07

Study locations

1 site
  • Mayo Clinic Minnesota
    Rochester, Minnesota 55905, United States
08

References and documents

Publications

  • 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. PubMed 41168214 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 26, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05940207
Lead sponsor
Mayo Clinic
Collaborators
National Institutes of Health (NIH)
Responsible party
Robin Patel (Principal Investigator, Mayo Clinic) — Principal investigator
First posted
Jul 11, 2023
Start date
Mar 27, 2024
Primary completion
May 2029 (estimated)
Completion
May 2029 (estimated)
Last update
Jan 26, 2026

Study contacts

Robin Patel, MD
principal investigator · Mayo Clinic

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.

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