NCT01061502CompletedPhase 1
Efficacy of the PROCELLERA Wound Dressing in the Healing of Skin Graft Donor Sites
Vomaris Innovations2 sites in 1 country17 target enrollmentStarted: September 1, 2009Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Enrollment
- 17
- Locations
- 2
- Primary Endpoint
- To compare epithelialization over time
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
To compare epithelialization over time
Time Frame: 3 months
Secondary Outcomes
- To compare patient reported perception of pain(3 months)
- To compare scarring(3 months)
Investigators
Study Sites (2)
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