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

October 28, 2009 updated by: Vomaris Innovations

Efficacy of the PROCELLERA Wound Dressing in the Healing of Wounds After Curettage and Electrodesiccation of Skin Lesions

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

15

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Oro Valley, Arizona, United States, 85755
        • Sheftel Associates Dermatology, LLC
      • Tucson, Arizona, United States, 85718
        • Sheftel Associates Dermatology, LLC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • PROCELLERA™, PROSIT™, Bioelectric Wound Dressing
Active Comparator: ACTICOAT™
Drug: ACTICOAT™ Antimicrobial Barrier Dressing
Dressing changes every 2-3 days, more frequently if needed
Other Names:
  • ACTICOAT™
Active Comparator: Mepilex® Ag
Drug: Mepilex® Ag Silver Foam Dressing
Dressing changes every 2-3 days, more frequently if needed
Other Names:
  • Mepilex® Ag

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Wound healing over time
Time Frame: July 2008-October 2009
July 2008-October 2009

Secondary Outcome Measures

Outcome Measure
Time Frame
Comparing three FDA cleared products for pain reduction and incidence of infection
Time Frame: July 2008-October 2009
July 2008-October 2009

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vomaris Innovations

Investigators

  • Principal Investigator: Scott N Sheftel, MD, Sheftel Associates Dermatology, LLC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2008

Primary Completion (Actual)

August 1, 2009

Study Completion (Actual)

October 1, 2009

Study Registration Dates

First Submitted

October 27, 2009

First Submitted That Met QC Criteria

October 28, 2009

First Posted (Estimate)

October 29, 2009

Study Record Updates

Last Update Posted (Estimate)

October 29, 2009

Last Update Submitted That Met QC Criteria

October 28, 2009

Last Verified

October 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • XSMP-011

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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