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

Vomaris Innovations

Status and phase

Completed

Phase 2

Conditions

Wound Healing

Wound Infection

Treatments

Drug: ACTICOAT™ Antimicrobial Barrier Dressing

Drug: Mepilex® Ag Silver Foam Dressing

Device: Procellera™ Antimicrobial Wound Dressing

Study type

Interventional

Funder types

Industry

Identifiers

NCT01004055

XSMP-011

Details and patient eligibility

About

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.

Enrollment

15 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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