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Efficacy Study of a Bioelectric Dressing to Treat Wounds Caused by Curettage and Electrodesiccation

This study has been completed.
Information provided by:
Vomaris Innovations Identifier:
First received: October 27, 2009
Last updated: October 28, 2009
Last verified: October 2009
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.

Condition Intervention Phase
Wound Healing Wound Infection Device: Procellera™ Antimicrobial Wound Dressing Drug: ACTICOAT™ Antimicrobial Barrier Dressing Drug: Mepilex® Ag Silver Foam Dressing Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Efficacy of the PROCELLERA Wound Dressing in the Healing of Wounds After Curettage and Electrodesiccation of Skin Lesions

Resource links provided by NLM:

Further study details as provided by Vomaris Innovations:

Primary Outcome Measures:
  • Wound healing over time [ Time Frame: July 2008-October 2009 ]

Secondary Outcome Measures:
  • Comparing three FDA cleared products for pain reduction and incidence of infection [ Time Frame: July 2008-October 2009 ]

Enrollment: 15
Study Start Date: July 2008
Study Completion Date: October 2009
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Procellera™ Wound Dressing 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
Active Comparator: ACTICOAT™ Drug: ACTICOAT™ Antimicrobial Barrier Dressing
Dressing changes every 2-3 days, more frequently if needed
Other Name: ACTICOAT™
Active Comparator: Mepilex® Ag Drug: Mepilex® Ag Silver Foam Dressing
Dressing changes every 2-3 days, more frequently if needed
Other Name: Mepilex® Ag


Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
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 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
  Contacts and Locations
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Please refer to this study by its identifier: NCT01004055

United States, Arizona
Sheftel Associates Dermatology, LLC
Oro Valley, Arizona, United States, 85755
Sheftel Associates Dermatology, LLC
Tucson, Arizona, United States, 85718
Sponsors and Collaborators
Vomaris Innovations
Principal Investigator: Scott N Sheftel, MD Sheftel Associates Dermatology, LLC
  More Information

Responsible Party: Scott Sheftel, MD, Sheftel Associates Dermatology, LLC Identifier: NCT01004055     History of Changes
Other Study ID Numbers: XSMP-011
Study First Received: October 27, 2009
Last Updated: October 28, 2009

Keywords provided by Vomaris Innovations:
Skin lesion

Additional relevant MeSH terms:
Wounds and Injuries
Wound Infection
Anti-Infective Agents
Anti-Bacterial Agents processed this record on July 25, 2017