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This is a multi-center, prospective, randomized, double blind, pilot clinical trial of subjects with chronic wounds. The purpose of this study is to compare the efficacy of COPA AMD PHMB Impregnated foam dressing compared to regular foam dressing in subjects with chronic wounds.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 | Active Comparator |
| |
| Arm 2 | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| COPA AMD (note: name is not an acronym) | Device | Foam dressing impregnated with Polyhexamethylene Biguanide |
|
| Measure | Description | Time Frame |
|---|---|---|
| Prevalence of Signs of Critical Colonization, Deep Infection, and Wound Healing Between the Two Groups | 5 weeks | |
| Percentage Change in Wound Surface Area (cm2) at Week 4 Compared to Week 0. | At each study visit, the subject's wound surface area was measured by longest length times widest width at right angles (LxW=cm2). Compiled data were analyzed to determine the median percentage decrease in wound surface area between groups and between study visits. Results report the median percentage decrease of the wound surface area as measured by cm2, comparing wound surface area at Week 4 to Week 0. | Weeks 0 and 4 |
| Measure | Description | Time Frame |
|---|---|---|
| Pain | 5 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| R. Gary Sibbald, MD | Community Dermatology and Wound Healing Clinic, Women's College Hospital- Dermatology Daycare & Wound Healing Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Community Dermatology and Wound Healing Clinic | Mississauga | Ontario | L4Y 1A6 | Canada | ||
| Women's College Hospital; Dermatology Daycare & Wound Healing Clinic |
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The first study subject was randomized on March 5, 2008 and the last subject visit was conducted on February 18, 2009. Subjects were screened for eligibility, consented, enrolled and randomized at two participating wound care clinics.
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| ID | Title | Description |
|---|---|---|
| FG000 | COPA AMD | Foam dressing impregnated with Polyhexamethylene Biguanide |
| FG001 | COPA | Regular foam dressing without Polyhexamethylene Biguanide |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | COPA AMD | Foam dressing impregnated with Polyhexamethylene Biguanide |
| BG001 | COPA | Regular foam dressing without Polyhexamethylene Biguanide |
| 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 | Prevalence of Signs of Critical Colonization, Deep Infection, and Wound Healing Between the Two Groups | Not Posted | 5 weeks | |||||||||||||
| Secondary | Pain | Not Posted | 5 weeks |
One year
Adverse events were assessed during each study visit (bi-weekly clinic visits) and as they occurred (e.g., adverse event is reported to the research team by subject, family member or other healthcare professional). Assessment type was a protocol specific coding system based on anticipated adverse events and physiological systems.
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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 | COPA AMD | Foam dressing impregnated with Polyhexamethylene Biguanide |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| cardiac stent implanted | Cardiac disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Head, eyes, ears, nose and throat | Ear and labyrinth disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Tonya Eggleston, RN, MPH, Study Director | Tyco Healthcare Group | (508) 261-8420 | Tonya.Eggleston@Covidien.com |
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| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
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| COPA (note: name is not an acronym) | Device | Regular foam dressing without PHMB |
|
| Toronto |
| Ontario |
| M5S 1B2 |
| Canada |
| Lost to Follow-up |
|
| BG002 | 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 |
|
| Primary | Percentage Change in Wound Surface Area (cm2) at Week 4 Compared to Week 0. | At each study visit, the subject's wound surface area was measured by longest length times widest width at right angles (LxW=cm2). Compiled data were analyzed to determine the median percentage decrease in wound surface area between groups and between study visits. Results report the median percentage decrease of the wound surface area as measured by cm2, comparing wound surface area at Week 4 to Week 0. | Per protocol | Posted | Jul 2009 | Median | Full Range | Percentage change | Weeks 0 and 4 |
|
|
|
| 0 |
| 22 |
| 5 |
| 22 |
| EG001 | COPA | Regular foam dressing without Polyhexamethylene Biguanide | 2 | 23 | 9 | 23 |
| pulmonary embolus | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Skin/Dermatologic (not including study wound) | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Wound Infection | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Endocrine, metabolic and nutritional | Metabolism and nutrition disorders | Systematic Assessment |
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| Allergic and immunologic | Endocrine disorders | Systematic Assessment |
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| Musculoskeletal | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Digestive/Gastrointestinal | Gastrointestinal disorders | Systematic Assessment |
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| Urogenital | Renal and urinary disorders | Systematic Assessment |
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| Hematopoietic/Lymphatic | Blood and lymphatic system disorders | Systematic Assessment |
|
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