NCT05940207

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P50-P75 for not_applicable healthy

Timeline
36mo left

Started Mar 2024

Longer than P75 for not_applicable healthy

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress42%
Mar 2024May 2029

First Submitted

Initial submission to the registry

July 3, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 11, 2023

Completed
9 months until next milestone

Study Start

First participant enrolled

March 27, 2024

Completed
5.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2029

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2029

Last Updated

January 26, 2026

Status Verified

January 1, 2026

Enrollment Period

5.1 years

First QC Date

July 3, 2023

Last Update Submit

January 22, 2026

Conditions

Healthy

Outcome Measures

Primary Outcomes (4)

  • 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.

    Approximately 3 - 24 hours

  • 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.

    Approximately 3 - 24 hours

  • 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.

    Approximately 3 - 24 hours

  • 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.

    Approximately 3 - 24 hours

Study Arms (5)

e-Bandages 3 hours

EXPERIMENTAL

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

Device: e-Bandages

e-Bandages 6 hours

EXPERIMENTAL

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

Device: e-Bandages

e-Bandages 12 hours

EXPERIMENTAL

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

Device: e-Bandages

e-Bandages 24 hours

EXPERIMENTAL

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

Device: e-Bandages

Control Group

EXPERIMENTAL

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

Device: e-Bandages

Interventions

e-BandagesDEVICE

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 Groupe-Bandages 12 hourse-Bandages 24 hourse-Bandages 3 hourse-Bandages 6 hours

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic Minnesota

Rochester, Minnesota, 55905, United States

Location

Related Publications (1)

  • 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.

    PMID: 41168214DERIVED

Study Officials

  • Robin Patel, MD

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
SEQUENTIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 3, 2023

First Posted

July 11, 2023

Study Start

March 27, 2024

Primary Completion (Estimated)

May 1, 2029

Study Completion (Estimated)

May 1, 2029

Last Updated

January 26, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations

US(1)