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

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.

Condition or disease Intervention/treatment Phase
Acute Wounds Other: Procellera™ Antimicrobial Dressing Other: Mepilex® Border Lite Device: Adhesive Bandage Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 26 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacy of the PROCELLERA™ Wound Dressing in the Healing of Wounds After a Curettage and Electrodesiccation of Skin Lesions
Study Start Date : March 2008
Actual Primary Completion Date : September 2008
Actual Study Completion Date : October 2008

Resource links provided by the National Library of Medicine

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:
  • 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 Name: Mepilex®

Active Comparator: Band-Aid® Adhesive Bandage
Dressing changes every 2-3 days, more frequently if needed.
Device: Adhesive Bandage
Adhesive bandage
Other Name: Band-Aid® Adhesive Bandage

Primary Outcome Measures :
  1. 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

Secondary Outcome Measures :
  1. 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.

  2. 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"

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00816101

United States, Arizona
Sheftel Associates Dermatology
Tucson, Arizona, United States, 85718
Sponsors and Collaborators
Vomaris Innovations
Principal Investigator: Scott N Sheftel, MD Sheftel Associates Dermatology

Responsible Party: Manager of Clinical Affairs, Vomaris Innovations, Inc. Identifier: NCT00816101     History of Changes
Other Study ID Numbers: XSMP-002
First Posted: December 31, 2008    Key Record Dates
Results First Posted: March 1, 2011
Last Update Posted: March 9, 2011
Last Verified: March 2011

Keywords provided by Vomaris Innovations:
Curettage and electrodesiccation
acute wounds
partial thickness wounds

Additional relevant MeSH terms:
Wounds and Injuries
Anti-Infective Agents
Anti-Bacterial Agents