Status:
COMPLETED
Efficacy Study of a New Antimicrobial Wound Dressing to Treat Wounds Caused by Curettage and Electrodesiccation
Lead Sponsor:
Vomaris Innovations
Conditions:
Acute Wounds
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
Brief Summary
The purpose of this pilot clinical study is to compare healing rates, pain levels, and incidence of wound complications including infection with the use of a moist PROCELLERA™ Antimicrobial Wound Dres...
Eligibility Criteria
Inclusion
- 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 1x1 cm
- Wounds 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
Exclusion
- 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
- Diabetes
- Venous stasis ulcers
- Participant undergoing active cancer chemotherapy
- Chronic steroid use
- Decision impairment
Key Trial Info
Start Date :
March 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2008
Estimated Enrollment :
26 Patients enrolled
Trial Details
Trial ID
NCT00816101
Start Date
March 1 2008
End Date
October 1 2008
Last Update
March 9 2011
Active Locations (1)
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1
Sheftel Associates Dermatology
Tucson, Arizona, United States, 85718