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Efficacy Study of a Bioelectric 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.
 
ClinicalTrials.gov Identifier: NCT01004055
Recruitment Status : Completed
First Posted : October 29, 2009
Last Update Posted : October 29, 2009
Sponsor:
Information provided by:
Vomaris Innovations

Tracking Information
First Submitted Date  ICMJE October 27, 2009
First Posted Date  ICMJE October 29, 2009
Last Update Posted Date October 29, 2009
Study Start Date  ICMJE July 2008
Actual Primary Completion Date August 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 28, 2009)
Wound healing over time [ Time Frame: July 2008-October 2009 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: October 28, 2009)
Comparing three FDA cleared products for pain reduction and incidence of infection [ Time Frame: July 2008-October 2009 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy Study of a Bioelectric Dressing to Treat Wounds Caused by Curettage and Electrodesiccation
Official Title  ICMJE Efficacy of the PROCELLERA Wound Dressing in the Healing of Wounds After Curettage and Electrodesiccation of Skin Lesions
Brief Summary The purpose of this study is to determine whether a bioelectric wound dressing, a silver-coated dressing, or a silver-foam dressing are effective in the treatment of wounds resulting from curettage and electrodesiccation of skin lesions.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Wound Healing
  • Wound Infection
Intervention  ICMJE
  • Device: Procellera™ Antimicrobial Wound Dressing
    Dressing indicated for partial and full-thickness wounds. Dressing changes every 2-3 days, more frequently if needed
    Other Name: PROCELLERA™, PROSIT™, Bioelectric Wound Dressing
  • Drug: ACTICOAT™ Antimicrobial Barrier Dressing
    Dressing changes every 2-3 days, more frequently if needed
    Other Name: ACTICOAT™
  • Drug: Mepilex® Ag Silver Foam Dressing
    Dressing changes every 2-3 days, more frequently if needed
    Other Name: Mepilex® Ag
Study Arms  ICMJE
  • Experimental: Procellera™ Wound Dressing
    Intervention: Device: Procellera™ Antimicrobial Wound Dressing
  • Active Comparator: ACTICOAT™
    Intervention: Drug: ACTICOAT™ Antimicrobial Barrier Dressing
  • Active Comparator: Mepilex® Ag
    Intervention: Drug: Mepilex® Ag Silver Foam Dressing
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 28, 2009)
15
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE October 2009
Actual Primary Completion Date August 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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 1x1cm
  • Wound 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
  • Collagen vascular disease
  • Diabetes
  • Venous stasis ulcers
  • Participant undergoing active cancer chemotherapy
  • Chronic steroid use
  • Decision impairment
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01004055
Other Study ID Numbers  ICMJE XSMP-011
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Scott Sheftel, MD, Sheftel Associates Dermatology, LLC
Study Sponsor  ICMJE Vomaris Innovations
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Scott N Sheftel, MD Sheftel Associates Dermatology, LLC
PRS Account Vomaris Innovations
Verification Date October 2009

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