Efficacy Study of a Bioelectric Dressing to Treat Skin Graft Donor Site Wounds

Study Overview
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Brief Summary
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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.

Official Title
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Efficacy of the PROCELLERA Wound Dressing in the Healing of Skin Graft Donor Sites

Conditions
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Burns, Wound Healing

Intervention / Treatment
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* Device: Procellera (Bioelectric Wound Dressing)
* Device: Opsite (Transparent Adhesive Dressing)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Procellera Wound Dressing<br>Dressing indicated for partial and full-thickness wounds. Dressing changes every 5-7 days, more frequently if needed | Device: Procellera (Bioelectric Wound Dressing)<br>* Dressing used on one-half of the donor graft site. Dressing changes every 5-7 days, more frequently if needed<br>* Other names: Procellera Device;|
| Active Comparator: Opsite Transparent Adhesive Dressing<br>Polyurethane film dressing. Dressing changes every 5-7 days, more frequently if needed | Device: Opsite (Transparent Adhesive Dressing)<br>* Semi-occlusive wound dressing placed on one-half of the skin graft donor site. Dressing change every 5-7 days, more frequently if needed.<br>* Other names: Opsite Dressing;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To compare epithelialization over time |  | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To compare patient reported perception of pain |  | 3 months | 
| To compare scarring |  | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Burns, Wounds and Injuries, Skin Grafts, Bioelectric, Grafting, skin