A Study of Hydrogen Peroxide-Generating E-bandage Safety

Study Overview
=================
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.

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

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Device: e-Bandages


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: e-Bandages 3 hours<br>Three subjects will wear the e-Bandage on their skin for 3 hours. | Device: e-Bandages<br>* 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.<br>|
| Experimental: e-Bandages 6 hours<br>Three subjects will wear the e-Bandage on their skin for 6 hours. | Device: e-Bandages<br>* 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.<br>|
| Experimental: e-Bandages 12 hours<br>Three subjects will wear the e-Bandage on their skin for 12 hours. | Device: e-Bandages<br>* 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.<br>|
| Experimental: e-Bandages 24 hours<br>Three subjects will wear the e-Bandage on their skin for 24 hours. | Device: e-Bandages<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |