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

This study has been completed.
Sponsor:
Information provided by:
Vomaris Innovations
ClinicalTrials.gov Identifier:
NCT01004055
First received: October 27, 2009
Last updated: October 28, 2009
Last verified: October 2009
  Purpose

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

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01004055

Locations
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
Investigators
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:
Wound
Skin lesion
Antimicrobial
Bioelectric

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

ClinicalTrials.gov processed this record on November 25, 2014