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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT01004055 |
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Date of registration:
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27/10/2009 |
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Primary sponsor: |
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Public title:
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Efficacy Study of a Bioelectric Dressing to Treat Wounds Caused by Curettage and Electrodesiccation
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Scientific title:
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Efficacy of the PROCELLERA Wound Dressing in the Healing of Wounds After Curettage and Electrodesiccation of Skin Lesions |
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Date of first enrolment:
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July 2008 |
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Target sample size:
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15 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT01004055 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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Countries of recruitment
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United States
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Contacts
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Name:
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Scott N Sheftel, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Sheftel Associates Dermatology, LLC |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- 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
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
- Collagen vascular disease
- Diabetes
- Venous stasis ulcers
- Participant undergoing active cancer chemotherapy
- Chronic steroid use
- Decision impairment
Age minimum:
18 Years
Age maximum:
80 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Wound Healing
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Wound Infection
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Intervention(s)
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Device: Procellera™ Antimicrobial Wound Dressing
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Drug: ACTICOAT™ Antimicrobial Barrier Dressing
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Drug: Mepilex® Ag Silver Foam Dressing
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Primary Outcome(s)
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Wound healing over time
[Time Frame: July 2008-October 2009]
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Secondary Outcome(s)
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Comparing three FDA cleared products for pain reduction and incidence of infection
[Time Frame: July 2008-October 2009]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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