Clincosm LogoSign in Get a demo

A Study of Hydrogen Peroxide-Generating E-bandage Safety

Sponsor
Mayo Clinic (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05940207
Collaborator
National Institutes of Health (NIH) (NIH)
20
Enrollment
1
Location
4
Arms
51.9
Anticipated Duration (Months)
0.4
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: e-Bandages
 Phase 1

Study Design

Study Type:
Interventional
Anticipated Enrollment :
20 participants
Allocation:
Non-Randomized
Intervention Model:
Sequential Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Safety Testing of Hydrogen Peroxide-Generating e-Bandage on Normal Human Skin
Anticipated Study Start Date :
Jan 1, 2025
Anticipated Primary Completion Date :
May 1, 2029
Anticipated Study Completion Date :
May 1, 2029

Arms and Interventions

Arm Intervention/Treatment
Experimental: e-Bandages 3 hours

Three subjects will wear the e-Bandage on their skin for 3 hours.

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.
Experimental: e-Bandages 6 hours

Three subjects will wear the e-Bandage on their skin for 6 hours.

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.
Experimental: e-Bandages 12 hours

Three subjects will wear the e-Bandage on their skin for 12 hours.

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.
Experimental: e-Bandages 24 hours

Three subjects will wear the e-Bandage on their skin for 24 hours.

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.

Outcome Measures

Primary Outcome Measures

  1. e-Bandage Discomfort [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 [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 [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 [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Mayo Clinic Minnesota Rochester Minnesota United States 55905

Sponsors and Collaborators

  • Mayo Clinic
  • National Institutes of Health (NIH)

Investigators

  • Principal Investigator: Robin Patel, MD, Mayo Clinic

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Robin Patel, Principal Investigator, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT05940207
Other Study ID Numbers:
  • 23-003805
First Posted:
Jul 11, 2023
Last Update Posted:
Jul 11, 2023
Last Verified:
Jul 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
Yes
Product Manufactured in and Exported from the U.S.:
No

Study Results

No Results Posted as of Jul 11, 2023