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

• Sponsor: Vomaris Innovations (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00816101
• Collaborator: (none)
• Enrollment: 26
• Location: 1
• Arms: 3
• Duration (Months): 7
• Patients Per Site Per Month: 3.7

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Acute Wounds	Other: Procellera™ Antimicrobial Dressing; Other: Mepilex® Border Lite; Device: Adhesive Bandage	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 26 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (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
• Study Start Date: Mar 1, 2008
• Actual Primary Completion Date: Sep 1, 2008
• Actual Study Completion Date: Oct 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
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 Names: Mepilex®
Active Comparator: Band-Aid® Adhesive Bandage Dressing changes every 2-3 days, more frequently if needed.	Device: Adhesive Bandage; Adhesive bandage; Other Names: Band-Aid® Adhesive Bandage

Outcome Measures

Primary Outcome Measures

1. Number of Patients Who Experienced 50% or Greater Wound Healing [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

Secondary Outcome Measures

1. Number of Patients Reporting Pain [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.

2. Erythema at Week 3 [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"

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	Sheftel Associates Dermatology	Tucson	Arizona	United States	85718

Sponsors and Collaborators

• Vomaris Innovations

Investigators

• Principal Investigator: Scott N Sheftel, MD, Sheftel Associates Dermatology

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00816101
• Other Study ID Numbers: XSMP-002
• First Posted: Dec 31, 2008
• Last Update Posted: Mar 9, 2011
• Last Verified: Mar 1, 2011

• Keywords provided by , ,: Curettage and electrodesiccation; acute wounds; partial thickness wounds
• Additional relevant MeSH terms: Wounds and Injuries; Anti-Infective Agents; Anti-Bacterial Agents

Study Results

Participant Flow

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

Arm/Group Title	Procellera Dressing	Mepilex® Border Lite	Band-Aid® Adhesive Bandage
Arm/Group Description	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	Self-adherent soft silicone foam dressing. Placed over wound following curettage and electrodesiccation. Dressing changes every 2-3 days, more frequently if needed	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.
Period Title: Overall Study
STARTED	13	8	5
COMPLETED	13	8	5
NOT COMPLETED	0	0	0

Baseline Characteristics

Arm/Group Title	Procellera Dressing	Mepilex® Border Lite	Band-Aid® Adhesive Bandage	Total
Arm/Group Description	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	Self-adherent soft silicone foam dressing. Placed over wound following curettage and electrodesiccation. Dressing changes every 2-3 days, more frequently if needed	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 of all reporting groups
Overall Participants	13	8	5	26
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%	0 0%
Between 18 and 65 years	1 7.7%	1 12.5%	1 20%	3 11.5%
>=65 years	12 92.3%	7 87.5%	4 80%	23 88.5%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	76.6 (8.4)	74.8 (9.9)	76.6 (8.4)	74.9 (8.6)
Sex: Female, Male (Count of Participants)
Female	4 30.8%	2 25%	2 40%	8 30.8%
Male	9 69.2%	6 75%	3 60%	18 69.2%
Region of Enrollment (participants) [Number]
United States	13 100%	8 100%	5 100%	26 100%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Procellera Dressing	Mepilex® Border Lite	Band-Aid® Adhesive Bandage
Arm/Group Description	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	Self-adherent soft silicone foam dressing. Placed over wound following curettage and electrodesiccation. Dressing changes every 2-3 days, more frequently if needed	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.
Measure Participants	13	8	5
Number [Participants]	13 100%	7 87.5%	4 80%

2. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Procellera Dressing	Mepilex® Border Lite	Band-Aid® Adhesive Bandage
Arm/Group Description	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	Self-adherent soft silicone foam dressing. Placed over wound following curettage and electrodesiccation. Dressing changes every 2-3 days, more frequently if needed	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.
Measure Participants	13	8	5
Number [Participants]	0 0%	0 0%	0 0%

3. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Procellera Dressing	Mepilex® Border Lite	Band-Aid® Adhesive Bandage
Arm/Group Description	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	Self-adherent soft silicone foam dressing. Placed over wound following curettage and electrodesiccation. Dressing changes every 2-3 days, more frequently if needed	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.
Measure Participants	13	8	5
Mean (Standard Deviation) [Erythema Scores on a Scale]	0.45 (0.82)	1.29 (1.11)	0.60 (0.55)

Adverse Events

Arm/Group Title	Procellera Dressing		Mepilex® Border Lite		Band-Aid® Adhesive Bandage
Arm/Group Description	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		Self-adherent soft silicone foam dressing. Placed over wound following curettage and electrodesiccation. Dressing changes every 2-3 days, more frequently if needed		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.
All Cause Mortality
	Procellera Dressing		Mepilex® Border Lite		Band-Aid® Adhesive Bandage
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	Procellera Dressing		Mepilex® Border Lite		Band-Aid® Adhesive Bandage
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/13 (0%)		0/8 (0%)		0/5 (0%)
Other (Not Including Serious) Adverse Events
	Procellera Dressing		Mepilex® Border Lite		Band-Aid® Adhesive Bandage
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/13 (0%)		0/8 (0%)		0/5 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.