Acute Wounds
Conditions
Keywords
Curettage and electrodesiccation, acute wounds, partial thickness wounds
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.
Interventions
OTHERProcellera™ Antimicrobial Dressing
Dressing indicated for partial and full-thickness wounds.
OTHERMepilex® Border Lite
Self-adherent foam dressing
DEVICEAdhesive Bandage
Adhesive bandage
Sponsors
Vomaris Innovations
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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 |
Countries
United States
Participant flow
Recruitment details
Recruitment dates: June 2008-August 2008 Location: Dermatology Clinic
Participants by arm
| Arm | Count |
|---|---|
| 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 | 13 |
| 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 | 8 |
| 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. | 5 |
| Total | 26 |
Baseline characteristics
| Characteristic | Mepilex® Border Lite | Band-Aid® Adhesive Bandage | Procellera Dressing | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 7 Participants | 4 Participants | 12 Participants | 23 Participants |
| Age, Categorical Between 18 and 65 years | 1 Participants | 1 Participants | 1 Participants | 3 Participants |
| Age Continuous | 74.8 years STANDARD_DEVIATION 9.9 | 76.6 years STANDARD_DEVIATION 8.4 | 76.6 years STANDARD_DEVIATION 8.4 | 74.9 years STANDARD_DEVIATION 8.6 |
| Region of Enrollment United States | 8 participants | 5 participants | 13 participants | 26 participants |
| Sex: Female, Male Female | 2 Participants | 2 Participants | 4 Participants | 8 Participants |
| Sex: Female, Male Male | 6 Participants | 3 Participants | 9 Participants | 18 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 13 | 0 / 8 | 0 / 5 |
| serious Total, serious adverse events | 0 / 13 | 0 / 8 | 0 / 5 |
Outcome results
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
Time frame: 3 Weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Procellera Dressing | Number of Patients Who Experienced 50% or Greater Wound Healing | 13 Participants |
| Mepilex® Border Lite | Number of Patients Who Experienced 50% or Greater Wound Healing | 7 Participants |
| Band-Aid® Adhesive Bandage | Number of Patients Who Experienced 50% or Greater Wound Healing | 4 Participants |
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
Time frame: 3 Weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Procellera Dressing | Erythema at Week 3 | 0.45 Erythema Scores on a Scale | Standard Deviation 0.82 |
| Mepilex® Border Lite | Erythema at Week 3 | 1.29 Erythema Scores on a Scale | Standard Deviation 1.11 |
| Band-Aid® Adhesive Bandage | Erythema at Week 3 | 0.60 Erythema Scores on a Scale | Standard Deviation 0.55 |
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.
Time frame: 3 Weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Procellera Dressing | Number of Patients Reporting Pain | 0 Participants |
| Mepilex® Border Lite | Number of Patients Reporting Pain | 0 Participants |
| Band-Aid® Adhesive Bandage | Number of Patients Reporting Pain | 0 Participants |