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

NCT ID: NCT00816101

Last Updated: 2011-03-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 26 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-03-31
• Study Completion Date: 2008-10-31

Brief 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.

Conditions

Acute Wounds

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

PROCELLERA™Antimicrobial Dressing

Dressing changes every 3 days, more frequently if needed

Group Type: EXPERIMENTAL

Procellera™ Antimicrobial Dressing

Intervention Type: OTHER

Dressing indicated for partial and full-thickness wounds.

Mepilex® Border Lite

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

Group Type: ACTIVE_COMPARATOR

Mepilex® Border Lite

Intervention Type: OTHER

Self-adherent foam dressing

Band-Aid® Adhesive Bandage

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

Group Type: ACTIVE_COMPARATOR

Adhesive Bandage

Intervention Type: DEVICE

Adhesive bandage

Interventions

Procellera™ Antimicrobial Dressing

Dressing indicated for partial and full-thickness wounds.

Intervention Type: OTHER

Mepilex® Border Lite

Self-adherent foam dressing

Intervention Type: OTHER

Adhesive Bandage

Adhesive bandage

Intervention Type: DEVICE

Other Intervention Names

PROCELLERA™; Prosit™ Antimicrobial Dressing; Prosit™ Technology; Mepilex®; Band-Aid® Adhesive Bandage

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Vomaris Innovations

INDUSTRY

Sponsor Role: lead

Responsible Party

Vomaris Innovations, Inc.

Principal Investigators

Scott N Sheftel, MD

Role: PRINCIPAL_INVESTIGATOR

Sheftel Associates Dermatology

Locations

Sheftel Associates Dermatology

Tucson, Arizona, United States

Countries

United States

Other Identifiers

XSMP-002

Identifier Type: -

Identifier Source: org_study_id