Efficacy Study of a New Antimicrobial Wound Dressing to Treat Wounds Caused by Curettage and Electrodesiccation
Primary Purpose
Acute Wounds
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Procellera™ Antimicrobial Dressing
Mepilex® Border Lite
Adhesive Bandage
Sponsored by
About this trial
This is an interventional treatment trial for Acute Wounds focused on measuring Curettage and electrodesiccation, acute wounds, partial thickness wounds
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
Sites / Locations
- Sheftel Associates Dermatology
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
Active Comparator
Arm Label
PROCELLERA™Antimicrobial Dressing
Mepilex® Border Lite
Band-Aid® Adhesive Bandage
Arm Description
Dressing changes every 3 days, more frequently if needed
Dressing changes every 2-3 days, more frequently if needed
Dressing changes every 2-3 days, more frequently if needed.
Outcomes
Primary Outcome Measures
Number of Patients Who Experienced 50% or Greater Wound Healing
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
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
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"
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00816101
Brief Title
Efficacy Study of a New Antimicrobial Wound Dressing to Treat Wounds Caused by Curettage and Electrodesiccation
Official Title
Efficacy of the PROCELLERA™ Wound Dressing in the Healing of Wounds After a Curettage and Electrodesiccation of Skin Lesions
Study Type
Interventional
2. Study Status
Record Verification Date
March 2011
Overall Recruitment Status
Completed
Study Start Date
March 2008 (undefined)
Primary Completion Date
September 2008 (Actual)
Study Completion Date
October 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Vomaris Innovations
4. Oversight
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Wounds
Keywords
Curettage and electrodesiccation, acute wounds, partial thickness wounds
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
26 (Actual)
8. Arms, Groups, and Interventions
Arm Title
PROCELLERA™Antimicrobial Dressing
Arm Type
Experimental
Arm Description
Dressing changes every 3 days, more frequently if needed
Arm Title
Mepilex® Border Lite
Arm Type
Active Comparator
Arm Description
Dressing changes every 2-3 days, more frequently if needed
Arm Title
Band-Aid® Adhesive Bandage
Arm Type
Active Comparator
Arm Description
Dressing changes every 2-3 days, more frequently if needed.
Intervention Type
Other
Intervention Name(s)
Procellera™ Antimicrobial Dressing
Other Intervention Name(s)
PROCELLERA™, Prosit™ Antimicrobial Dressing, Prosit™ Technology
Intervention Description
Dressing indicated for partial and full-thickness wounds.
Intervention Type
Other
Intervention Name(s)
Mepilex® Border Lite
Other Intervention Name(s)
Mepilex®
Intervention Description
Self-adherent foam dressing
Intervention Type
Device
Intervention Name(s)
Adhesive Bandage
Other Intervention Name(s)
Band-Aid® Adhesive Bandage
Intervention Description
Adhesive bandage
Primary Outcome Measure Information:
Title
Number of Patients Who Experienced 50% or Greater Wound Healing
Description
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
Time Frame
3 Weeks
Secondary Outcome Measure Information:
Title
Number of Patients Reporting Pain
Description
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.
Time Frame
3 Weeks
Title
Erythema at Week 3
Description
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"
Time Frame
3 Weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Scott N Sheftel, MD
Organizational Affiliation
Sheftel Associates Dermatology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sheftel Associates Dermatology
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85718
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Efficacy Study of a New Antimicrobial Wound Dressing to Treat Wounds Caused by Curettage and Electrodesiccation
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