Back to resultsEfficacy Study of a Bioelectric Dressing to Treat Skin Graft Donor Site Wounds
Primary Purpose
Burns, Wound Healing
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Procellera (Bioelectric Wound Dressing)
Opsite (Transparent Adhesive Dressing)
Sponsored by
About this trial
This is an interventional treatment trial for Burns focused on measuring Burns, Wounds and Injuries, Skin Grafts, Bioelectric, Grafting, skin
Eligibility Criteria
Inclusion Criteria:
- Wounds resulting from skin graft
- Split thickness wound
- Wound size greater than 2x2 cm
- Wounds must be ≥5 cm away from all other wounds
- 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
- Peripheral vascular occlusive disease
- Collagen vascular disease
- Connective tissue disease
- Participant undergoing active cancer chemotherapy
- Chronic steroid use
- Decision impairment
Sites / Locations
- Blodgett Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Procellera Wound Dressing
Opsite Transparent Adhesive Dressing
Arm Description
Dressing indicated for partial and full-thickness wounds. Dressing changes every 5-7 days, more frequently if needed
Polyurethane film dressing. Dressing changes every 5-7 days, more frequently if needed
Outcomes
Primary Outcome Measures
To compare epithelialization over time
Secondary Outcome Measures
To compare patient reported perception of pain
To compare scarring
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01061502
Brief Title
Efficacy Study of a Bioelectric Dressing to Treat Skin Graft Donor Site Wounds
Official Title
Efficacy of the PROCELLERA Wound Dressing in the Healing of Skin Graft Donor Sites
Study Type
Interventional
2. Study Status
Record Verification Date
December 2010
Overall Recruitment Status
Completed
Study Start Date
September 2009 (undefined)
Primary Completion Date
November 2010 (Actual)
Study Completion Date
November 2010 (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 the use of a bioelectric wound dressing is effective in the healing of skin graft donor site wounds.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Burns, Wound Healing
Keywords
Burns, Wounds and Injuries, Skin Grafts, Bioelectric, Grafting, skin
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
Outcomes Assessor
Allocation
Non-Randomized
Enrollment
17 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Procellera Wound Dressing
Arm Type
Experimental
Arm Description
Dressing indicated for partial and full-thickness wounds. Dressing changes every 5-7 days, more frequently if needed
Arm Title
Opsite Transparent Adhesive Dressing
Arm Type
Active Comparator
Arm Description
Polyurethane film dressing. Dressing changes every 5-7 days, more frequently if needed
Intervention Type
Device
Intervention Name(s)
Procellera (Bioelectric Wound Dressing)
Other Intervention Name(s)
Procellera, PROSIT, Procellera Wound Dressing, Procellera Device
Intervention Description
Dressing used on one-half of the donor graft site. Dressing changes every 5-7 days, more frequently if needed
Intervention Type
Device
Intervention Name(s)
Opsite (Transparent Adhesive Dressing)
Other Intervention Name(s)
Opsite Dressing
Intervention Description
Semi-occlusive wound dressing placed on one-half of the skin graft donor site. Dressing change every 5-7 days, more frequently if needed.
Primary Outcome Measure Information:
Title
To compare epithelialization over time
Time Frame
3 months
Secondary Outcome Measure Information:
Title
To compare patient reported perception of pain
Time Frame
3 months
Title
To compare scarring
Time Frame
3 months
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:
Wounds resulting from skin graft
Split thickness wound
Wound size greater than 2x2 cm
Wounds must be ≥5 cm away from all other wounds
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
Peripheral vascular occlusive disease
Collagen vascular disease
Connective tissue disease
Participant undergoing active cancer chemotherapy
Chronic steroid use
Decision impairment
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrew L Blount, MD
Organizational Affiliation
Blodgett Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Richard Wilcox, MD
Organizational Affiliation
Blodgett Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Blodgett Hospital
City
Grand Rapids
State/Province
Michigan
ZIP/Postal Code
49503
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Efficacy Study of a Bioelectric Dressing to Treat Skin Graft Donor Site Wounds
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