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

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

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.

Study Overview

• Status: Completed
• Conditions: Acute Wounds
• Intervention / Treatment: Other: Procellera™ Antimicrobial Dressing; Other: Mepilex® Border Lite; Device: Adhesive Bandage

• Study Type: Interventional
• Enrollment (Actual): 26
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Tucson, Arizona, United States, 85718
      • Sheftel Associates Dermatology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 78 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PROCELLERA™Antimicrobial Dressing; Dressing changes every 3 days, more frequently if needed	Other: Procellera™ Antimicrobial Dressing; Dressing indicated for partial and full-thickness wounds.; Other Names: PROCELLERA™; Prosit™ Antimicrobial Dressing; Prosit™ Technology
Active Comparator: Mepilex® Border Lite; Dressing changes every 2-3 days, more frequently if needed	Other: Mepilex® Border Lite; Self-adherent foam dressing; Other Names: Mepilex®
Active Comparator: Band-Aid® Adhesive Bandage; Dressing changes every 2-3 days, more frequently if needed.	Device: Adhesive Bandage; Adhesive bandage; Other Names: Band-Aid® Adhesive Bandage

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Vomaris Innovations
• Investigators: Principal Investigator: Scott N Sheftel, MD, Sheftel Associates Dermatology

Study record dates

Study Major Dates

• Study Start: March 1, 2008
• Primary Completion (Actual): September 1, 2008
• Study Completion (Actual): October 1, 2008

Study Registration Dates

• First Submitted: October 21, 2008
• First Submitted That Met QC Criteria: December 30, 2008
• First Posted (Estimate): December 31, 2008

Study Record Updates

• Last Update Posted (Estimate): March 9, 2011
• Last Update Submitted That Met QC Criteria: March 4, 2011
• Last Verified: March 1, 2011

More Information

Terms related to this study

• Keywords: Curettage and electrodesiccation; acute wounds; partial thickness wounds
• Additional Relevant MeSH Terms: Wounds and Injuries; Anti-Bacterial Agents; Anti-Infective Agents
• Other Study ID Numbers: XSMP-002