Phase 2 Completed N=26 Randomized Treatment

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

Acute Wounds

Source: ClinicalTrials.gov NCT00816101 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Mar 2011

Primary outcomePrimary: Number of Patients Who Experienced 50% or Greater Wound Healing — 13; 7; 4 Participants

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.

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	—

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

View full record on ClinicalTrials.gov →

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. Informational only — not medical advice.