Efficacy Study of a Bioelectric Dressing to Treat Wounds Caused by Curettage and Electrodesiccation

• Status: Completed
• Trial end date: 2009-10-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine whether a bioelectric wound dressing, a silver-coated dressing, or a silver-foam dressing are effective in the treatment of wounds resulting from curettage and electrodesiccation of skin lesions.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Vomaris Innovations
• Treatments: Anti-Bacterial Agents; Anti-Infective Agents

Criteria

Inclusion Criteria:

• If female, must either be not of childbearing potential or if they are of childbearing potential must have a negative urine pregnancy test

• Wound size greater than 1x1cm

• Wound must be ≥5 cm away from all other wounds

• Wound size must not be diminished in size greater than 10% between enrollment in study and the prescreening

• Participant agrees to participate in follow-up evaluation

• Participant must be able to read and understand informed consent, and sign the informed consent

Exclusion Criteria:

• Concurrent participation in another clinical trial that involves an investigational drug or device that would interfere with this study

• Participant is to receive another topical antimicrobial agent other than the study dressing

• Participant with sensitivity or adverse reactions to silver or zinc

• Pregnancy or nursing an infant or child

• Immunosuppression

• Active or systemic infection

• Collagen vascular disease

• Diabetes

• Venous stasis ulcers

• Participant undergoing active cancer chemotherapy

• Chronic steroid use

• Decision impairment