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

Wound Infection Clinical Trial

Official title:

Efficacy of the PROCELLERA Wound Dressing in the Healing of Wounds After Curettage and Electrodesiccation of Skin Lesions

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01004055
• Other study ID #: XSMP-011
• Status: Completed
• Phase: Phase 2
• First received: October 27, 2009
• Last updated: October 28, 2009
• Start date: July 2008
• Est. completion date: October 2009

Study information

• Verified date: October 2009
• Source: Vomaris Innovations
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: October 2009
• Est. primary completion date: August 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Wound Healing
• Wound Infection
• Wounds and Injuries

Intervention

Device:
• Procellera™ Antimicrobial Wound Dressing
Dressing indicated for partial and full-thickness wounds. Dressing changes every 2-3 days, more frequently if needed

Drug:
• ACTICOAT™ Antimicrobial Barrier Dressing
Dressing changes every 2-3 days, more frequently if needed
• Mepilex® Ag Silver Foam Dressing
Dressing changes every 2-3 days, more frequently if needed

Locations

Country	Name	City	State
United States	Sheftel Associates Dermatology, LLC	Oro Valley	Arizona
United States	Sheftel Associates Dermatology, LLC	Tucson	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Vomaris Innovations

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Wound healing over time		July 2008-October 2009
Secondary	Comparing three FDA cleared products for pain reduction and incidence of infection		July 2008-October 2009