A Study of Hydrogen Peroxide-Generating E-bandage Safety

Phase 1

Not yet recruiting

• Conditions: Healthy
• Interventions: Device: e-Bandages

• Registration Number: NCT05940207
• Lead Sponsor: Mayo Clinic

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-07
• Study First Submitted: 2023-07-03
• Study First Submitted QC: 2023-07-03
• Last Update Submitted: 2023-07-03
• Study First Posted: 2023-07-11
• Last Update Posted: 2023-07-11
• Study Start: 2025-01
• Primary Completion: 2029-05
• Study Completion: 2029-05

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 20

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
e-Bandages 3 hours	e-Bandages	Three subjects will wear the e-Bandage on their skin for 3 hours.
e-Bandages 6 hours	e-Bandages	Three subjects will wear the e-Bandage on their skin for 6 hours.
e-Bandages 12 hours	e-Bandages	Three subjects will wear the e-Bandage on their skin for 12 hours.
e-Bandages 24 hours	e-Bandages	Three subjects will wear the e-Bandage on their skin for 24 hours.

Primary Outcome Measures

Name	Time	Method
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.
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.
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.
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.

Trial Locations

Locations (1)

Mayo Clinic Minnesota; 🇺🇸 Rochester, Minnesota, United States