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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00816101
Recruitment Status : Completed
First Posted : December 31, 2008
Results First Posted : March 1, 2011
Last Update Posted : March 9, 2011
Information provided by:
Vomaris Innovations

October 21, 2008
December 31, 2008
December 13, 2010
March 1, 2011
March 9, 2011
March 2008
September 2008   (Final data collection date for primary outcome measure)
Number of Patients Who Experienced 50% or Greater Wound Healing [ Time Frame: 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
Wound healing over time [ Time Frame: May-September 2008 ]
Complete list of historical versions of study NCT00816101 on Archive Site
  • Number of Patients Reporting Pain [ Time Frame: 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 [ Time Frame: 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"
Comparing two FDA cleared products for pain reduction and incidence of infection [ Time Frame: May 2008-September 2008 ]
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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.
Not Provided
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Acute Wounds
  • Other: Procellera™ Antimicrobial Dressing
    Dressing indicated for partial and full-thickness wounds.
    Other Names:
    • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
October 2008
September 2008   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 80 Years   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
United States
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Manager of Clinical Affairs, Vomaris Innovations, Inc.
Vomaris Innovations
Not Provided
Principal Investigator: Scott N Sheftel, MD Sheftel Associates Dermatology
Vomaris Innovations
March 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP