HealthyNCT05940207
A Study of Hydrogen Peroxide-Generating E-bandage Safety
A study testing e-Bandages in people with Healthy, run by Mayo Clinic at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- e-Bandages
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Mar 2024to May 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy.
- Intact skin on arms.
- Able to provide appropriate consent.
Who cannot join
- Vulnerable study population.
- Pregnancy.
- Children.
- Skin disease.
- Non-intact skin on arms.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Safety Testing of Hydrogen Peroxide-Generating e-Bandage on Normal Human Skin
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.
- Conditions
- Healthy
- Being tested
- e-Bandages
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| e-Bandages 3 hours | Experimental | Four subjects will wear the e-Bandage on their skin for 24 hours, with active polarization for 3 hours. Receives: 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. Receives: 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. Receives: 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. Receives: Device: e-Bandages |
| Control Group | Experimental | Four subjects will wear the e-Bandage on their skin for 24 hours, with no active polarization. Receives: Device: e-Bandages |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Approximately 3 - 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2023
- Study start27 Mar 2024
- Primary completionMay 2029 (estimated)
- Study completionMay 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Responsible party
- Principal investigator, Robin Patel, Mayo Clinic
- Investigators
- Robin Patel, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05940207
- Sponsor's protocol ID
- 23-003805
- Status last verified
- Jan 2026
- First submitted
- 3 Jul 2023
- Last updated
- 26 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety Testing of Hydrogen Peroxide-Generating e-Bandage on Normal Human Skin
- ClinicalTrials.gov ID
- NCT05940207
- Acronym / sponsor ID
- 23-003805
- Conditions
- Healthy
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Study start
- 27 Mar 2024 (actual)
- Primary completion
- May 2029 (estimated)
- Study completion
- May 2029 (estimated)
- First posted
- 11 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| e-Bandages 3 hours | Experimental | Device: e-BandagesFour subjects will wear the e-Bandage on their skin for 24 hours, with active polarization for 3 hours. |
| e-Bandages 6 hours | Experimental | Device: e-BandagesFour subjects will wear the e-Bandage on their skin for 24 hours, with active polarization for 6 hours. |
| e-Bandages 12 hours | Experimental | Device: e-BandagesFour subjects will wear the e-Bandage on their skin for 24 hours, with active polarization for 12 hours. |
| e-Bandages 24 hours | Experimental | Device: e-BandagesFour subjects will wear the e-Bandage on their skin for 24 hours, with active polarization for 24 hours. |
| Control Group | Experimental | Device: e-BandagesFour subjects will wear the e-Bandage on their skin for 24 hours, with no active polarization. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Healthy.
- Intact skin on arms.
- Able to provide appropriate consent.
Key exclusion criteria (5 listed)
- Vulnerable study population.
- Pregnancy.
- Children.
- Skin disease.
- Non-intact skin on arms.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| e-BandagesA 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. | Device | Control Group, e-Bandages 12 hours, e-Bandages 24 hours, e-Bandages 3 hours, e-Bandages 6 hours |
Primary outcome
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.
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.
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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2026.
- Derived from this study: PubMed 41168214Kies 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robin Patel, MD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing e-Bandages in people with Healthy, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 26 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
e-Bandage Discomfort (time frame: Approximately 3 - 24 hours). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05940207, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jan 2026.