Phase 2
N=26
Efficacy Study of a New Antimicrobial Wound Dressing to Treat Wounds Caused by Curettage and Electrodesiccation
Acute Wounds
Bottom Line
View on ClinicalTrials.gov: NCT00816101 ↗Enrolled (actual)
26
Serious AEs
0.0%
Results posted
Mar 2011
Primary outcome: Primary: Number of Patients Who Experienced 50% or Greater Wound Healing — 13; 7; 4 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Procellera™ Antimicrobial Dressing (Other); Mepilex® Border Lite (Other); Adhesive Bandage (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Vomaris Innovations
- Primary completion
- Sep 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Patients Who Experienced 50% or Greater Wound Healing |
13; 7; 4 | — |
| SECONDARY Number of Patients Reporting Pain |
0; 0; 0 | — |
| SECONDARY Erythema at Week 3 |
0.45; 1.29; 0.60 | — |
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 Dressing when compared to a standard dressing, Mepilex® Border Lite, following curettage and electrodesiccation of skin lesions.
Eligibility Criteria
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 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 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
- Diabetes
- Venous stasis ulcers
- Participant undergoing active cancer chemotherapy
- Chronic steroid use
- Decision impairment
Data sourced from ClinicalTrials.gov (NCT00816101). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.