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

Study Overview
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Brief Summary
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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.

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

Conditions
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Wound Healing, Wound Infection

Intervention / Treatment
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* Device: Procellera™ Antimicrobial Wound Dressing
* Drug: ACTICOAT™ Antimicrobial Barrier Dressing
* Drug: Mepilex® Ag Silver Foam Dressing


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Procellera™ Wound Dressing<br> | Device: Procellera™ Antimicrobial Wound Dressing<br>* Dressing indicated for partial and full-thickness wounds. Dressing changes every 2-3 days, more frequently if needed<br>* Other names: PROCELLERA™, PROSIT™, Bioelectric Wound Dressing;|
| Active Comparator: ACTICOAT™<br> | Drug: ACTICOAT™ Antimicrobial Barrier Dressing<br>* Dressing changes every 2-3 days, more frequently if needed<br>* Other names: ACTICOAT™;|
| Active Comparator: Mepilex® Ag<br> | Drug: Mepilex® Ag Silver Foam Dressing<br>* Dressing changes every 2-3 days, more frequently if needed<br>* Other names: Mepilex® Ag;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Wound healing over time |  | July 2008-October 2009 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparing three FDA cleared products for pain reduction and incidence of infection |  | July 2008-October 2009 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Wound, Skin lesion, Antimicrobial, Bioelectric