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

Vomaris Innovations

Status and phase: Completed; Phase 2; Phase 1

Conditions: Wound Healing; Burns

Treatments: Device: Procellera (Bioelectric Wound Dressing); Device: Opsite (Transparent Adhesive Dressing)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01061502

XSMP-014

Details and patient eligibility

About

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.

Enrollment: 17 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: Single Blind

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17 participants in 2 patient groups

Procellera Wound Dressing

Experimental group

Description:

Dressing indicated for partial and full-thickness wounds. Dressing changes every 5-7 days, more frequently if needed

Treatment:

Device: Procellera (Bioelectric Wound Dressing)

Opsite Transparent Adhesive Dressing

Active Comparator group

Description:

Polyurethane film dressing. Dressing changes every 5-7 days, more frequently if needed

Treatment:

Device: Opsite (Transparent Adhesive Dressing)