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

This study has been completed.
Sponsor:
Information provided by:
Vomaris Innovations
ClinicalTrials.gov Identifier:
NCT00816101
First received: October 21, 2008
Last updated: March 4, 2011
Last verified: March 2011

October 21, 2008
March 4, 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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00816101 on ClinicalTrials.gov Archive Site
  • 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"
Comparing two FDA cleared products for pain reduction and incidence of infection [ Time Frame: May 2008-September 2008 ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
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
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Acute Wounds
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
26
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
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00816101
XSMP-002
No
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