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

Vomaris Innovations

Status and phase: Completed; Phase 2

Conditions: Acute Wounds

Treatments: Other: Procellera™ Antimicrobial Dressing; Device: Adhesive Bandage; Other: Mepilex® Border Lite

Study type: Interventional

Funder types: Industry

Identifiers

NCT00816101

XSMP-002

Details and patient eligibility

About

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.

Enrollment: 26 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

26 participants in 3 patient groups

PROCELLERA™Antimicrobial Dressing

Experimental group

Description:

Dressing changes every 3 days, more frequently if needed

Treatment:

Other: Procellera™ Antimicrobial Dressing

Mepilex® Border Lite

Active Comparator group

Description:

Dressing changes every 2-3 days, more frequently if needed

Treatment:

Other: Mepilex® Border Lite

Band-Aid® Adhesive Bandage

Active Comparator group

Description:

Dressing changes every 2-3 days, more frequently if needed.

Treatment:

Device: Adhesive Bandage