Efficacy Study of a New Antimicrobial Wound 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 pilot clinical study is to compare healing rates, pain levels, and incidence of wound complications including infection with the use of a moist PROCELLERA™ Antimicrobial Wound Dressing when compared to a standard dressing, Mepilex® Border Lite, following curettage and electrodesiccation of skin lesions.

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

Conditions
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Acute Wounds

Intervention / Treatment
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* Other: Procellera™ Antimicrobial Dressing
* Other: Mepilex® Border Lite
* Device: Adhesive Bandage


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 1x1 cm Wounds 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 Peripheral vascular occlusive disease Collagen vascular disease Connective tissue 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™Antimicrobial Dressing<br>Dressing changes every 3 days, more frequently if needed | Other: Procellera™ Antimicrobial Dressing<br>* Dressing indicated for partial and full-thickness wounds.<br>* Other names: Prosit™ Technology;|
| Active Comparator: Mepilex® Border Lite<br>Dressing changes every 2-3 days, more frequently if needed | Other: Mepilex® Border Lite<br>* Self-adherent foam dressing<br>* Other names: Mepilex®;|
| Active Comparator: Band-Aid® Adhesive Bandage<br>Dressing changes every 2-3 days, more frequently if needed. | Device: Adhesive Bandage<br>* Adhesive bandage<br>* Other names: Band-Aid® Adhesive Bandage;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Patients Who Experienced 50% or Greater Wound Healing | Participants were assessed to see whether or not the wound area was reduced by at least 50%, and the number of such participants is reported | 3 Weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Patients Reporting Pain | Participants recorded their subjective pain level on a 0-10 Numeric Pain Chart 3x/day (0=no pain, 10=worst pain imaginable), until they had no pain for 3 consecutive days. Participants were also given a Patient Medication Log to complete at home to record RX and OTC medication they took to relieve pain. They were instructed to write the medication name, dosage, and amount of pills they took, as well as time taken, every day they took pain medication. Participants reporting pain had an associated score. | 3 Weeks | 
| Erythema at Week 3 | At each weekly follow up visit, wound erythema was evaluated by the clinician on a scale of 0-4, with 0 being No erythema, 1 being Very slight erythema, 2 being Well defined erythema, 3 being Moderate to severe erythema and 4 being Severe erythema to slight eschar formation | 3 Weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Curettage and electrodesiccation, acute wounds, partial thickness wounds