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

This study has been completed.
Information provided by:
Vomaris Innovations
ClinicalTrials.gov 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
Endpoint Classification: Efficacy Study
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

Further study details as provided by Vomaris Innovations:

Primary Outcome Measures:
  • Wound healing over time [ Time Frame: July 2008-October 2009 ] [ Designated as safety issue: No ]

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

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
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov 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

No publications provided

Responsible Party: Scott Sheftel, MD, Sheftel Associates Dermatology, LLC
ClinicalTrials.gov Identifier: NCT01004055     History of Changes
Other Study ID Numbers: XSMP-011
Study First Received: October 27, 2009
Last Updated: October 28, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by Vomaris Innovations:
Skin lesion

Additional relevant MeSH terms:
Wound Infection
Wounds and Injuries
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 23, 2014