search
Back to results

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

Primary Purpose

Wound Healing, Wound Infection

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Procellera™ Antimicrobial Wound Dressing
ACTICOAT™ Antimicrobial Barrier Dressing
Mepilex® Ag Silver Foam Dressing
Sponsored by
Vomaris Innovations
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Wound Healing focused on measuring Wound, Skin lesion, Antimicrobial, Bioelectric

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Sheftel Associates Dermatology, LLC
  • Sheftel Associates Dermatology, LLC

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Active Comparator

Arm Label

Procellera™ Wound Dressing

ACTICOAT™

Mepilex® Ag

Arm Description

Outcomes

Primary Outcome Measures

Wound healing over time

Secondary Outcome Measures

Comparing three FDA cleared products for pain reduction and incidence of infection

Full Information

First Posted
October 27, 2009
Last Updated
October 28, 2009
Sponsor
Vomaris Innovations
search

1. Study Identification

Unique Protocol Identification Number
NCT01004055
Brief Title
Efficacy Study of a Bioelectric Dressing to Treat Wounds Caused by Curettage and Electrodesiccation
Official Title
Efficacy of the PROCELLERA Wound Dressing in the Healing of Wounds After Curettage and Electrodesiccation of Skin Lesions
Study Type
Interventional

2. Study Status

Record Verification Date
October 2009
Overall Recruitment Status
Completed
Study Start Date
July 2008 (undefined)
Primary Completion Date
August 2009 (Actual)
Study Completion Date
October 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Vomaris Innovations

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Wound Healing, Wound Infection
Keywords
Wound, Skin lesion, Antimicrobial, Bioelectric

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
15 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Procellera™ Wound Dressing
Arm Type
Experimental
Arm Title
ACTICOAT™
Arm Type
Active Comparator
Arm Title
Mepilex® Ag
Arm Type
Active Comparator
Intervention Type
Device
Intervention Name(s)
Procellera™ Antimicrobial Wound Dressing
Other Intervention Name(s)
PROCELLERA™, PROSIT™, Bioelectric Wound Dressing
Intervention Description
Dressing indicated for partial and full-thickness wounds. Dressing changes every 2-3 days, more frequently if needed
Intervention Type
Drug
Intervention Name(s)
ACTICOAT™ Antimicrobial Barrier Dressing
Other Intervention Name(s)
ACTICOAT™
Intervention Description
Dressing changes every 2-3 days, more frequently if needed
Intervention Type
Drug
Intervention Name(s)
Mepilex® Ag Silver Foam Dressing
Other Intervention Name(s)
Mepilex® Ag
Intervention Description
Dressing changes every 2-3 days, more frequently if needed
Primary Outcome Measure Information:
Title
Wound healing over time
Time Frame
July 2008-October 2009
Secondary Outcome Measure Information:
Title
Comparing three FDA cleared products for pain reduction and incidence of infection
Time Frame
July 2008-October 2009

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Scott N Sheftel, MD
Organizational Affiliation
Sheftel Associates Dermatology, LLC
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sheftel Associates Dermatology, LLC
City
Oro Valley
State/Province
Arizona
ZIP/Postal Code
85755
Country
United States
Facility Name
Sheftel Associates Dermatology, LLC
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85718
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs