Efficacy Study of a Bioelectric Dressing to Treat Wounds Caused by Curettage and Electrodesiccation
Efficacy of the PROCELLERA Wound Dressing in the Healing of Wounds After Curettage and Electrodesiccation of Skin Lesions
1 other identifier
interventional
15
1 country
2
Brief Summary
The purpose of this study is to determine whether a bioelectric wound dressing, a silver-coated dressing, or a silver-foam dressing are effective in the treatment of wounds resulting from curettage and electrodesiccation of skin lesions.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Jul 2008
Shorter than P25 for phase_2
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2009
CompletedFirst Submitted
Initial submission to the registry
October 27, 2009
CompletedFirst Posted
Study publicly available on registry
October 29, 2009
CompletedOctober 29, 2009
October 1, 2009
1.1 years
October 27, 2009
October 28, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Wound healing over time
July 2008-October 2009
Secondary Outcomes (1)
Comparing three FDA cleared products for pain reduction and incidence of infection
July 2008-October 2009
Study Arms (3)
Procellera™ Wound Dressing
EXPERIMENTALACTICOAT™
ACTIVE COMPARATORMepilex® Ag
ACTIVE COMPARATORInterventions
Dressing indicated for partial and full-thickness wounds. Dressing changes every 2-3 days, more frequently if needed
Dressing changes every 2-3 days, more frequently if needed
Dressing changes every 2-3 days, more frequently if needed
Eligibility Criteria
You may qualify if:
- If female, must either be not of childbearing potential or if they are of childbearing potential must have a negative urine pregnancy test
- Wound size greater than 1x1cm
- Wound must be ≥5 cm away from all other wounds
- Wound size must not be diminished in size greater than 10% between enrollment in study and the prescreening
- Participant agrees to participate in follow-up evaluation
- Participant must be able to read and understand informed consent, and sign the informed consent
You may not qualify if:
- 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
- Collagen vascular disease
- Diabetes
- Venous stasis ulcers
- Participant undergoing active cancer chemotherapy
- Chronic steroid use
- Decision impairment
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Sheftel Associates Dermatology, LLC
Oro Valley, Arizona, 85755, United States
Sheftel Associates Dermatology, LLC
Tucson, Arizona, 85718, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Scott N Sheftel, MD
Sheftel Associates Dermatology, LLC
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
October 27, 2009
First Posted
October 29, 2009
Study Start
July 1, 2008
Primary Completion
August 1, 2009
Study Completion
October 1, 2009
Last Updated
October 29, 2009
Record last verified: 2009-10