Efficacy Study of a New Antimicrobial Wound Dressing to Treat Wounds Caused by Curettage and Electrodesiccation

• Number of Patients Reporting Pain [ Time Frame: 3 Weeks ] [ Designated as safety issue: No ]
  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.
• Erythema at Week 3 [ Time Frame: 3 Weeks ] [ Designated as safety issue: No ]
  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"

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.

• Other: Procellera™ Antimicrobial Dressing
  Dressing indicated for partial and full-thickness wounds.
  Other Names:

  • PROCELLERA™
  • Prosit™ Antimicrobial Dressing
  • Prosit™ Technology
• Other: Mepilex® Border Lite
  Self-adherent foam dressing
  Other Name: Mepilex®
• Device: Adhesive Bandage
  Adhesive bandage
  Other Name: Band-Aid® Adhesive Bandage

• Experimental: PROCELLERA™Antimicrobial Dressing
  Dressing changes every 3 days, more frequently if needed
  Intervention: Other: Procellera™ Antimicrobial Dressing
• Active Comparator: Mepilex® Border Lite
  Dressing changes every 2-3 days, more frequently if needed
  Intervention: Other: Mepilex® Border Lite
• Active Comparator: Band-Aid® Adhesive Bandage
  Dressing changes every 2-3 days, more frequently if needed.
  Intervention: Device: Adhesive Bandage

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