Electric Bandage Safety for Wound Care

Age: 18+
Sex: Any
Trial Phase: Phase 1
Sponsor: Mayo Clinic
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines the safety of a new type of bandage, called an e-Bandage, which produces a small amount of hydrogen peroxide to aid in wound healing and infection prevention. The goal is to determine if these bandages are safe and non-harmful to normal skin. Participants will wear the e-Bandage for varying durations, from 3 to 24 hours. This trial is ideal for healthy individuals with no skin issues on their arms who can consent to participate. As a Phase 1 trial, the research focuses on understanding how the e-Bandage functions in people, offering participants the chance to be among the first to experience this innovative treatment.

Do I need to stop my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators.

What prior data suggests that this e-bandage is safe for wound care?

Research has shown that hydrogen peroxide-generating e-bandages are safe for use on healthy skin. One study found that wearing these bandages for up to 24 hours caused no major problems. The study reported no serious side effects, indicating their safety for wound treatment. Current research focuses on confirming that these e-bandages do not cause harm or irritation when used on normal skin.12345

Why are researchers excited about this trial?

Researchers are excited about e-Bandages because they introduce an innovative approach to wound care. Unlike traditional bandages that simply cover a wound, e-Bandages use electrical stimulation to potentially enhance healing. This cutting-edge technology aims to accelerate the body's natural repair processes, offering a new way to tackle chronic wounds or slow-healing injuries. Additionally, the e-Bandages come in different durations of application, ranging from 3 to 24 hours, providing flexibility in treatment and potentially optimizing healing times based on patient needs. This adaptability and novel mechanism of action set e-Bandages apart from standard wound care options.

What evidence suggests that this e-bandage is effective for wound care?

Research has shown that e-bandages, which produce hydrogen peroxide, can help wounds heal faster. In this trial, participants will wear e-bandages for varying durations to assess safety and effectiveness. One study found that these bandages are safe on healthy skin for up to 24 hours, with no major side effects. This makes them a promising option for treating long-lasting wounds, as they allow for effective home care. The bandages not only aid healing but also monitor important factors like temperature and moisture. Early results suggest that these smart bandages could significantly improve wound treatment.12678

Who Is on the Research Team?

RP

Robin Patel, MD

Principal Investigator

Mayo Clinic

Are You a Good Fit for This Trial?

This trial is for healthy adults with unbroken skin on their arms who can give informed consent. It's not suitable for vulnerable populations, pregnant women, children, or those with any skin diseases or damaged skin on their arms.

Inclusion Criteria

Healthy
My skin on my arms is healthy, without wounds or rashes.
Able to provide appropriate consent

Exclusion Criteria

Pregnancy
I have broken skin or wounds on my arms.
I have a skin condition.
See 1 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 week

Treatment

Participants wear the e-Bandage for varying durations to assess safety and lack of toxicity

3-24 hours
1 visit (in-person)

Follow-up

Participants are monitored for skin discoloration, discomfort, irritation, and allergic reactions after e-Bandage removal

1 week

What Are the Treatments Tested in This Trial?

Interventions

  • e-Bandages
Trial Overview The study is testing the safety of a new type of e-bandage that generates hydrogen peroxide to prevent and treat wound infections and promote healing when applied to normal human skin.
How Is the Trial Designed?
4Treatment groups
Experimental Treatment
Group I: e-Bandages 6 hoursExperimental Treatment1 Intervention
Group II: e-Bandages 3 hoursExperimental Treatment1 Intervention
Group III: e-Bandages 24 hoursExperimental Treatment1 Intervention
Group IV: e-Bandages 12 hoursExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials
3,427
Recruited
3,221,000+

National Institutes of Health (NIH)

Collaborator

Trials
2,896
Recruited
8,053,000+

Published Research Related to This Trial

A new elastic bandage system can provide consistent compression pressure, which is crucial for treating patients with superficial venous incompetence, as demonstrated in a study with 25 patients.
When the bandage was applied with non-stretchable patches, it significantly improved venous ejection fraction (EF) to normal levels, indicating that inelastic compression is more effective than traditional elastic bandages for enhancing venous blood flow.
A New Two Component Compression System Turning an Elastic Bandage into an Inelastic Compression Device: Interface Pressure, Stiffness, and Haemodynamic Effectiveness.Mosti, G., Partsch, H.[2019]

Citations

A Bioelectrically Enabled Smart Bandage for Accelerated ...The findings demonstrate that EF-based smart bandages significantly enhance wound healing and enable highly accurate prediction of outcomes through machine ...
Safety trial assessing 1.77 cm2 H2O2 producing ... - NatureIn conclusion, 1.77 cm2 H2O2-generating e-bandages were well tolerated on healthy human skin for up to 24 h, though further development is ...
New “smart bandages” hold potential for revolutionizing ...We're creating a new kind of 'cyber skin' that can help these wounds heal, while measuring and managing them along the way,” David Armstrong ...
Smart bandage: A device for wound monitoring and ...This review paper gives information on the latest updates in smart bandage technology that can monitor various biomarkers such as temperature, moisture, oxygen ...
Electric Bandage Holds Promise for Treating Chronic ...This innovative bandage, which is easy to use at home, represents a significant advancement in wound care by providing an effective and low-cost ...
A Study of Hydrogen Peroxide-Generating E-bandage SafetyA hydrogen-peroxide generating e-bandage for wound infection and treatment and prevention. Each e-bandage is composed of three electrodes - a working, a counter ...
Electric Bandage Safety for Wound Care · Info for ParticipantsThe 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 ...
Producing Electrochemical Bandages Are Active Using Off- ...To this end, a H2O2-producing electrochemical bandage (e-bandage) is being developed for wound infection prevention and treatment, as well as ...
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