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

This study has been completed.

First Received: October 21, 2008 Last Updated: December 30, 2008 History of Changes

Sponsored by:	Vomaris Innovations
Information provided by:	Vomaris Innovations
ClinicalTrials.gov Identifier:	NCT00816101

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
Partial Thickness Wounds	Other: Procellera™ Antimicrobial Dressing Other: Mepilex® Border Lite	Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
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:

Wound healing over time [ Time Frame: May-September 2008 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Comparing two FDA cleared products for pain reduction and incidence of infection [ Time Frame: May 2008-September 2008 ] [ Designated as safety issue: No ]

Enrollment:	20
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
PROCELLERA™Antimicrobial Dressing: Experimental Dressing changes every 3 days, more frequently if needed	Other: Procellera™ Antimicrobial Dressing Dressing indicated for partial and full-thickness wounds.
Mepilex® Border Lite: Active Comparator Dressing changes every 2-3 days, more frequently if needed	Other: Mepilex® Border Lite Self-adherent foam dressing

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:	Vomaris Innovations, Inc. ( Manager of Clinical Affairs )
Study ID Numbers:	XSMP-002
Study First Received:	October 21, 2008
Last Updated:	December 30, 2008
ClinicalTrials.gov Identifier:	NCT00816101 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Vomaris Innovations:

Curettage and electrodesiccation
acute wounds
partial thickness wounds

Study placed in the following topic categories:

Anti-Infective Agents

Additional relevant MeSH terms:

Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 02, 2009