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

Purpose

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	Intervention	Phase
Acute Wounds	Other: Procellera™ Antimicrobial Dressing Other: Mepilex® Border Lite Device: Adhesive Bandage	Phase 2

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: 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

Further study details as provided by Vomaris Innovations:

Primary Outcome Measures:

Number of Patients Who Experienced 50% or Greater Wound Healing [ Time Frame: 3 Weeks ] [ Designated as safety issue: No ]
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:

Number of Patients Reporting Pain [ Time Frame: 3 Weeks ] [ Designated as safety issue: No ]
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.
Erythema at Week 3 [ Time Frame: 3 Weeks ] [ Designated as safety issue: No ]
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"

Enrollment:	26
Study Start Date:	March 2008
Study Completion Date:	October 2008
Primary Completion Date:	September 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

Eligibility

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00816101

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

No publications provided

Responsible Party:	Manager of Clinical Affairs, Vomaris Innovations, Inc.
ClinicalTrials.gov Identifier:	NCT00816101 History of Changes
Other Study ID Numbers:	XSMP-002
Study First Received:	October 21, 2008
Results First Received:	December 13, 2010
Last Updated:	March 4, 2011
Health Authority:	United States: Institutional Review Board

Keywords provided by Vomaris Innovations:

Curettage and electrodesiccation
acute wounds
partial thickness wounds

Additional relevant MeSH terms:

Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 16, 2013