Efficacy Study of a Bioelectric Dressing to Treat Wounds Caused by Curettage and Electrodesiccation

Phase 2

Completed

• Conditions: Wound Healing; Wound Infection
• Interventions: Device: Procellera™ Antimicrobial Wound Dressing; Drug: ACTICOAT™ Antimicrobial Barrier Dressing; Drug: Mepilex® Ag Silver Foam Dressing

• Registration Number: NCT01004055
• Lead Sponsor: Vomaris Innovations

Brief Summary

The purpose of this study is to determine whether a bioelectric wound dressing, a silver-coated dressing, or a silver-foam dressing are effective in the treatment of wounds resulting from curettage and electrodesiccation of skin lesions.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-07
• Primary Completion: 2009-08
• Status Verified: 2009-10
• Study Completion: 2009-10
• Study First Submitted: 2009-10-27
• Study First Submitted QC: 2009-10-28
• Last Update Submitted: 2009-10-28
• Study First Posted: 2009-10-29
• Last Update Posted: 2009-10-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Procellera™ Wound Dressing	Procellera™ Antimicrobial Wound Dressing	-
ACTICOAT™	ACTICOAT™ Antimicrobial Barrier Dressing	-
Mepilex® Ag	Mepilex® Ag Silver Foam Dressing	-

Primary Outcome Measures

Name	Time	Method
Wound healing over time	July 2008-October 2009

Secondary Outcome Measures

Name	Time	Method
Comparing three FDA cleared products for pain reduction and incidence of infection	July 2008-October 2009

Trial Locations

Locations (1)

Sheftel Associates Dermatology, LLC; 🇺🇸 Tucson, Arizona, United States