Efficacy Study of a New Antimicrobial Wound Dressing to Treat Wounds Caused by Curettage and Electrodesiccation
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|ClinicalTrials.gov Identifier: NCT00816101|
Recruitment Status : Completed
First Posted : December 31, 2008
Results First Posted : March 1, 2011
Last Update Posted : March 9, 2011
|Condition or disease||Intervention/treatment||Phase|
|Acute Wounds||Other: Procellera™ Antimicrobial Dressing Other: Mepilex® Border Lite Device: Adhesive Bandage||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||26 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Efficacy of the PROCELLERA™ Wound Dressing in the Healing of Wounds After a Curettage and Electrodesiccation of Skin Lesions|
|Study Start Date :||March 2008|
|Actual Primary Completion Date :||September 2008|
|Actual Study Completion Date :||October 2008|
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.
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
Other Name: Band-Aid® Adhesive Bandage
- Number of Patients Who Experienced 50% or Greater Wound Healing [ Time Frame: 3 Weeks ]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
- Number of Patients Reporting Pain [ Time Frame: 3 Weeks ]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 ]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"
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00816101
|United States, Arizona|
|Sheftel Associates Dermatology|
|Tucson, Arizona, United States, 85718|
|Principal Investigator:||Scott N Sheftel, MD||Sheftel Associates Dermatology|