Electric Bandage Safety for Wound Care

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Mayo Clinic

Disqualifiers: Pregnancy, Children, Skin disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 3-24 hours

20 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

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.

Is the electric bandage safe for use in humans?

The safety of electric bandages, similar to other electrosurgical devices, can be a concern due to risks like burns and electrical shock. Proper use, monitoring, and adherence to safety guidelines are crucial to minimize these risks. ^{1 2 3 4 5}

How does the electric bandage treatment differ from other wound care treatments?

The electric bandage treatment is unique because it likely involves the use of electrical stimulation to promote wound healing, which is different from traditional bandages that rely solely on compression or protection. This approach may offer a novel mechanism of action by potentially enhancing blood flow or cellular activity at the wound site, unlike standard bandages that do not have these capabilities. ^{6 7 8 9 10}

What data supports the effectiveness of the e-Bandages treatment for wound care?

Research on a similar wearable electrical stimulation bandage in rats showed successful use for wound healing over seven days, suggesting potential benefits for chronic wound treatment. ^{8 11 12 13 14}

Who Is on the Research Team?

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.

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?

Group I: e-Bandages 6 hours Experimental Treatment 1 Intervention

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

Group II: e-Bandages 3 hours Experimental Treatment 1 Intervention

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

Group III: e-Bandages 24 hours Experimental Treatment 1 Intervention

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

Group IV: e-Bandages 12 hours Experimental Treatment 1 Intervention

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

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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

1. England pubmed.ncbi.nlm.nih.gov

A comparison of sub-bandage pressures produced by experienced and inexperienced bandagers. [2019]

2. China pubmed.ncbi.nlm.nih.gov

[Design of combined lower limb elastic compression device and comparative study with elastic bandage]. [2021]

3. England pubmed.ncbi.nlm.nih.gov

What is the existing evidence supporting the efficacy of compression bandage systems containing both elastic and inelastic components (mixed-component systems)? A systematic review. [2018]

4. England pubmed.ncbi.nlm.nih.gov

Design and evaluation of a device for measurement of interface pressure. [2019]

5. United States pubmed.ncbi.nlm.nih.gov

A wearable stimulation bandage for electrotherapy studies in a rat ischemic wound model. [2020]

6. Denmark pubmed.ncbi.nlm.nih.gov

[Burns caused by electric surgical instruments]. [2006]

7. United States pubmed.ncbi.nlm.nih.gov

Guidelines in Practice: Electrosurgical Safety. [2021]

8. United States pubmed.ncbi.nlm.nih.gov

Human skin burns induced by defibrillator default current. [2004]

9. France pubmed.ncbi.nlm.nih.gov

[Electric burns in the operating room. Apropos of 4 cases]. [2006]

10. Brazil pubmed.ncbi.nlm.nih.gov

[Burns related to electrosurgery - Report of two cases]. [2019]

11. United States pubmed.ncbi.nlm.nih.gov

The Iatrogenic Injury Potential of Self-adherent Elastic Bandages in Finger Injuries. [2023]

12. England pubmed.ncbi.nlm.nih.gov

Alterations in pressure under elastic bandages: experimental and clinical evaluation. [2019]

13. England pubmed.ncbi.nlm.nih.gov

The influence of bandage characteristics and inter-individual application variations on underneath bandage pressures. [2019]

14. England pubmed.ncbi.nlm.nih.gov

A New Two Component Compression System Turning an Elastic Bandage into an Inelastic Compression Device: Interface Pressure, Stiffness, and Haemodynamic Effectiveness. [2019]