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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PROCELLERA™Antimicrobial Dressing | Experimental | Dressing changes every 3 days, more frequently if needed |
|
| Mepilex® Border Lite | Active Comparator | Dressing changes every 2-3 days, more frequently if needed |
|
| Band-Aid® Adhesive Bandage | Active Comparator | Dressing changes every 2-3 days, more frequently if needed. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Procellera™ Antimicrobial Dressing | Other | Dressing indicated for partial and full-thickness wounds. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 3 Weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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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.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Scott N Sheftel, MD | Sheftel Associates Dermatology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sheftel Associates Dermatology | Tucson | Arizona | 85718 | United States |
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Recruitment dates: June 2008-August 2008 Location: Dermatology Clinic
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| ID | Title | Description |
|---|---|---|
| FG000 | Procellera Dressing | Antimicrobial dressing for partial and full-thickness wounds. Produces small amount of current when in contact with conductive fluid. Used as primary contact layer for wound following curettage and electrodesiccation. Dressing changes every 3 days, more frequently if needed |
| FG001 | Mepilex® Border Lite | Self-adherent soft silicone foam dressing. Placed over wound following curettage and electrodesiccation. Dressing changes every 2-3 days, more frequently if needed |
| FG002 | Band-Aid® Adhesive Bandage | Adhesive bandage containing absorbtive pad secured to self-adherent strip. Placed over wound caused by curettage & electrodesiccation. Dressing changes every 2-3 days, more frequently if needed. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Procellera Dressing | Antimicrobial dressing for partial and full-thickness wounds. Produces small amount of current when in contact with conductive fluid. Used as primary contact layer for wound following curettage and electrodesiccation. Dressing changes every 3 days, more frequently if needed |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | Posted | Number | Participants | 3 Weeks |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Procellera Dressing | Antimicrobial dressing for partial and full-thickness wounds. Produces small amount of current when in contact with conductive fluid. Used as primary contact layer for wound following curettage and electrodesiccation. Dressing changes every 3 days, more frequently if needed |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Scott Sheftel, MD | Sheftel Associates Dermatology, LLC | 520-293-5757 | 7106 | ssheftel@sheftelderm.com |
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| Mepilex® Border Lite | Other | Self-adherent foam dressing |
|
|
| Adhesive Bandage | Device | Adhesive bandage |
|
|
| 3 Weeks |
| 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" | 3 Weeks |
| Mepilex® Border Lite |
Self-adherent soft silicone foam dressing. Placed over wound following curettage and electrodesiccation. Dressing changes every 2-3 days, more frequently if needed |
| BG002 | Band-Aid® Adhesive Bandage | Adhesive bandage containing absorbtive pad secured to self-adherent strip. Placed over wound caused by curettage & electrodesiccation. Dressing changes every 2-3 days, more frequently if needed. |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG002 | Band-Aid® Adhesive Bandage | Adhesive bandage containing absorbtive pad secured to self-adherent strip. Placed over wound caused by curettage & electrodesiccation. Dressing changes every 2-3 days, more frequently if needed. |
|
|
| Secondary | 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. | Posted | Number | Participants | 3 Weeks |
|
|
|
| Secondary | 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" | Posted | Mean | Standard Deviation | Erythema Scores on a Scale | 3 Weeks |
|
|
|
| 0 |
| 13 |
| 0 |
| 13 |
| EG001 | Mepilex® Border Lite | Self-adherent soft silicone foam dressing. Placed over wound following curettage and electrodesiccation. Dressing changes every 2-3 days, more frequently if needed | 0 | 8 | 0 | 8 |
| EG002 | Band-Aid® Adhesive Bandage | Adhesive bandage containing absorbtive pad secured to self-adherent strip. Placed over wound caused by curettage & electrodesiccation. Dressing changes every 2-3 days, more frequently if needed. | 0 | 5 | 0 | 5 |
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