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

Efficacy of the PROCELLERA Wound Dressing in the Healing of Wounds After Curettage and Electrodesiccation of Skin Lesions

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01004055

Enrollment

Registered

2009-10-29

Start date

2008-07-31

Completion date

2009-10-31

Last updated

2009-10-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Wound Healing, Wound Infection

Keywords

Wound, Skin lesion, Antimicrobial, Bioelectric

Brief 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.

Interventions

DEVICEProcellera™ Antimicrobial Wound Dressing

Dressing indicated for partial and full-thickness wounds. Dressing changes every 2-3 days, more frequently if needed

DRUGACTICOAT™ Antimicrobial Barrier Dressing

Dressing changes every 2-3 days, more frequently if needed

DRUGMepilex® Ag Silver Foam Dressing

Dressing changes every 2-3 days, more frequently if needed

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

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

Design outcomes

Primary

Measure	Time frame
Wound healing over time	July 2008-October 2009

Secondary

Measure	Time frame
Comparing three FDA cleared products for pain reduction and incidence of infection	July 2008-October 2009

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026