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NCT05940207 Clinical Trial

A Study of Hydrogen Peroxide-Generating E-bandage Safety

Healthy Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT05940207
Other study ID # 23-003805
Secondary ID
Status Not yet recruiting
Phase Phase 1
First received
Last updated
Start date January 2025
Est. completion date May 2029

Study information
Verified date July 2023
Source Mayo Clinic
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 20
Est. completion date May 2029
Est. primary completion date May 2029
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• e-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.

Locations
Country Name City State
United States Mayo Clinic Minnesota Rochester Minnesota

Sponsors (2)
Lead Sponsor Collaborator
Mayo Clinic National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary 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
Primary 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
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