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

Phase 1

Completed

• Conditions: Burns; Wound Healing
• Interventions: Device: Procellera (Bioelectric Wound Dressing); Device: Opsite (Transparent Adhesive Dressing)

• Registration Number: NCT01061502
• Lead Sponsor: Vomaris Innovations

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-09
• Study First Submitted: 2010-02-01
• Study First Submitted QC: 2010-02-02
• Study First Posted: 2010-02-03
• Primary Completion: 2010-11
• Study Completion: 2010-11
• Status Verified: 2010-12
• Last Update Submitted: 2010-12-09
• Last Update Posted: 2010-12-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 17

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Procellera Wound Dressing	Procellera (Bioelectric Wound Dressing)	Dressing indicated for partial and full-thickness wounds. Dressing changes every 5-7 days, more frequently if needed
Opsite Transparent Adhesive Dressing	Opsite (Transparent Adhesive Dressing)	Polyurethane film dressing. Dressing changes every 5-7 days, more frequently if needed

Primary Outcome Measures

Name	Time	Method
To compare epithelialization over time	3 months

Secondary Outcome Measures

Name	Time	Method
To compare patient reported perception of pain	3 months
To compare scarring	3 months

Trial Locations

Locations (1)

Blodgett Hospital; 🇺🇸 Grand Rapids, Michigan, United States