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

Phase 2

Completed

Interventions: Other: Mepilex® Border Lite
Other: Procellera™ Antimicrobial Dressing
Device: Adhesive Bandage

Brief Summary: 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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Mepilex® Border Lite	Mepilex® Border Lite	Dressing changes every 2-3 days, more frequently if needed
PROCELLERA™Antimicrobial Dressing	Procellera™ Antimicrobial Dressing	Dressing changes every 3 days, more frequently if needed
Band-Aid® Adhesive Bandage	Adhesive Bandage	Dressing changes every 2-3 days, more frequently if needed.

Primary Outcome Measures

Name	Time	Method
Number of Patients Who Experienced 50% or Greater Wound Healing	3 Weeks	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

Secondary Outcome Measures

Name	Time	Method
Number of Patients Reporting Pain	3 Weeks	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	3 Weeks	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"