Trial Outcomes & Findings for Efficacy Study of a New Antimicrobial Wound Dressing to Treat Wounds Caused by Curettage and Electrodesiccation (NCT NCT00816101)

NCT ID: NCT00816101

Last Updated: 2011-03-09

Results Overview

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

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 26 participants
• Primary outcome timeframe: 3 Weeks
• Results posted on: 2011-03-09

Participant Flow

Recruitment dates: June 2008-August 2008 Location: Dermatology Clinic

Participant milestones

Measure	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	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	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.
Overall Study STARTED	13	8	5
Overall Study COMPLETED	13	8	5
Overall Study NOT COMPLETED	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Procellera Dressing n=13 Participants 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	Mepilex® Border Lite n=8 Participants Self-adherent soft silicone foam dressing. Placed over wound following curettage and electrodesiccation. Dressing changes every 2-3 days, more frequently if needed	Band-Aid® Adhesive Bandage n=5 Participants 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.	Total n=26 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	1 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	3 Participants n=4 Participants
Age, Categorical >=65 years	12 Participants n=5 Participants	7 Participants n=7 Participants	4 Participants n=5 Participants	23 Participants n=4 Participants
Age Continuous	76.6 years STANDARD_DEVIATION 8.4 • n=5 Participants	74.8 years STANDARD_DEVIATION 9.9 • n=7 Participants	76.6 years STANDARD_DEVIATION 8.4 • n=5 Participants	74.9 years STANDARD_DEVIATION 8.6 • n=4 Participants
Sex: Female, Male Female	4 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants	8 Participants n=4 Participants
Sex: Female, Male Male	9 Participants n=5 Participants	6 Participants n=7 Participants	3 Participants n=5 Participants	18 Participants n=4 Participants
Region of Enrollment United States	13 participants n=5 Participants	8 participants n=7 Participants	5 participants n=5 Participants	26 participants n=4 Participants

PRIMARY outcome

Timeframe: 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

Outcome measures

Measure	Procellera Dressing n=13 Participants 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	Mepilex® Border Lite n=8 Participants Self-adherent soft silicone foam dressing. Placed over wound following curettage and electrodesiccation. Dressing changes every 2-3 days, more frequently if needed	Band-Aid® Adhesive Bandage n=5 Participants 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.
Number of Patients Who Experienced 50% or Greater Wound Healing	13 Participants	7 Participants	4 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Procellera Dressing n=13 Participants 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	Mepilex® Border Lite n=8 Participants Self-adherent soft silicone foam dressing. Placed over wound following curettage and electrodesiccation. Dressing changes every 2-3 days, more frequently if needed	Band-Aid® Adhesive Bandage n=5 Participants 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.
Number of Patients Reporting Pain	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 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"

Outcome measures

Measure	Procellera Dressing n=13 Participants 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	Mepilex® Border Lite n=8 Participants Self-adherent soft silicone foam dressing. Placed over wound following curettage and electrodesiccation. Dressing changes every 2-3 days, more frequently if needed	Band-Aid® Adhesive Bandage n=5 Participants 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.
Erythema at Week 3	0.45 Erythema Scores on a Scale Standard Deviation 0.82	1.29 Erythema Scores on a Scale Standard Deviation 1.11	0.60 Erythema Scores on a Scale Standard Deviation 0.55

Adverse Events

Procellera Dressing

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Mepilex® Border Lite

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Band-Aid® Adhesive Bandage

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Scott Sheftel, MD

Sheftel Associates Dermatology, LLC

Phone: 520-293-5757

Email: ssheftel@sheftelderm.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place