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

This study has been completed.
Sponsor:
Information provided by:
Vomaris Innovations
ClinicalTrials.gov Identifier:
NCT00816101
First received: October 21, 2008
Last updated: March 4, 2011
Last verified: March 2011
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014