Efficacy Study of a New Antimicrobial Wound Dressing to Treat Wounds Caused by Curettage and Electrodesiccation

Completed · Phase 2

Conditions studied: Acute Wounds

In brief

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 Dressing when compared to a standard dressing, Mepilex® Border Lite, following curettage and electrodesiccation of skin lesions.

Key facts

Study ID

NCT00816101

Run by

Vomaris Innovations

People needed

26

Starts

2008-03-01

Expected to finish

2008-10-01

Last updated by the study team

2011-03-09

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

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 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

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
• Peripheral vascular occlusive disease
• Collagen vascular disease
• Connective tissue disease
• Diabetes
• Venous stasis ulcers
• Participant undergoing active cancer chemotherapy
• Chronic steroid use
• Decision impairment

Where it is running

• Sheftel Associates Dermatology — Tucson, Arizona, United States

Full record on ClinicalTrials.gov

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