A Study of Hydrogen Peroxide-Generating E-bandage Safety
Status
Active, not recruiting
Conditions
Healthy
Treatments
Device: e-Bandages
Details and patient eligibility
About
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.
Enrollment
40 estimated patients
Sex
All
Ages
18 to 99 years old
Volunteers
Accepts Healthy Volunteers
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.
Trial design
Primary purpose
Other
Allocation
Non-Randomized
Interventional model
Sequential Assignment
Masking
None (Open label)
40 participants in 5 patient groups
e-Bandages 3 hours
Experimental group
Description:
Four subjects will wear the e-Bandage on their skin for 24 hours, with active polarization for 3 hours.
Treatment:
Device: e-Bandages
e-Bandages 6 hours
Experimental group
Description:
Four subjects will wear the e-Bandage on their skin for 24 hours, with active polarization for 6 hours.
Treatment:
Device: e-Bandages
e-Bandages 12 hours
Experimental group
Description:
Four subjects will wear the e-Bandage on their skin for 24 hours, with active polarization for 12 hours.
Treatment:
Device: e-Bandages
e-Bandages 24 hours
Experimental group
Description:
Four subjects will wear the e-Bandage on their skin for 24 hours, with active polarization for 24 hours.
Treatment:
Device: e-Bandages
Control Group
Experimental group
Description:
Four subjects will wear the e-Bandage on their skin for 24 hours, with no active polarization.
Treatment:
Device: e-Bandages
Trial contacts and locations
1
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Data sourced from clinicaltrials.gov
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