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

• ClinicalTrials.gov Identifier: NCT00816101
• Recruitment Status: Completed
• First Posted: December 31, 2008
• Results First Posted: March 1, 2011
• Last Update Posted: March 9, 2011
• Sponsor: Vomaris Innovations
• Information provided by: Vomaris Innovations

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Acute Wounds	Other: Procellera™ Antimicrobial Dressing; Other: Mepilex® Border Lite; Device: Adhesive Bandage	Phase 2

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 26 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Efficacy of the PROCELLERA™ Wound Dressing in the Healing of Wounds After a Curettage and Electrodesiccation of Skin Lesions
• Study Start Date: March 2008
• Actual Primary Completion Date: September 2008
• Actual Study Completion Date: October 2008

Arms and Interventions

Arm	Intervention/treatment
Experimental: PROCELLERA™Antimicrobial Dressing; Dressing changes every 3 days, more frequently if needed	Other: Procellera™ Antimicrobial Dressing; Dressing indicated for partial and full-thickness wounds.; Other Names: PROCELLERA™; Prosit™ Antimicrobial Dressing; Prosit™ Technology
Active Comparator: Mepilex® Border Lite; Dressing changes every 2-3 days, more frequently if needed	Other: Mepilex® Border Lite; Self-adherent foam dressing; Other Name: Mepilex®
Active Comparator: Band-Aid® Adhesive Bandage; Dressing changes every 2-3 days, more frequently if needed.	Device: Adhesive Bandage; Adhesive bandage; Other Name: Band-Aid® Adhesive Bandage

Outcome Measures

Primary Outcome Measures :

1. Number of Patients Who Experienced 50% or Greater Wound Healing [ Time Frame: 3 Weeks ]
   Participants were assessed to see whether or not the wound area was reduced by at least 50%, and the number of such participants is reported

Secondary Outcome Measures :

1. Number of Patients Reporting Pain [ Time Frame: 3 Weeks ]
   Participants recorded their subjective pain level on a 0-10 Numeric Pain Chart 3x/day (0=no pain, 10=worst pain imaginable), until they had no pain for 3 consecutive days. Participants were also given a Patient Medication Log to complete at home to record RX and OTC medication they took to relieve pain. They were instructed to write the medication name, dosage, and amount of pills they took, as well as time taken, every day they took pain medication. Participants reporting pain had an associated score.
2. Erythema at Week 3 [ Time Frame: 3 Weeks ]
   At each weekly follow up visit, wound erythema was evaluated by the clinician on a scale of 0-4, with "0" being "No erythema", "1" being "Very slight erythema", "2" being "Well defined erythema", "3" being "Moderate to severe erythema" and 4 being "Severe erythema to slight eschar formation"

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 80 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

United States, Arizona

Sheftel Associates Dermatology

Tucson, Arizona, United States, 85718

Sponsors and Collaborators

Vomaris Innovations

Investigators

• Principal Investigator: Scott N Sheftel, MD; Sheftel Associates Dermatology

More Information

• Responsible Party: Manager of Clinical Affairs, Vomaris Innovations, Inc.
• ClinicalTrials.gov Identifier: NCT00816101
• Other Study ID Numbers: XSMP-002
• First Posted: December 31, 2008
• Results First Posted: March 1, 2011
• Last Update Posted: March 9, 2011
• Last Verified: March 2011

Keywords provided by Vomaris Innovations:

Curettage and electrodesiccation; acute wounds; partial thickness wounds

Additional relevant MeSH terms:

Wounds and Injuries; Anti-Infective Agents; Anti-Bacterial Agents