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Chronic wounds are a source of significant morbidity and escalated healthcare costs. The wound care professional has a myriad of modern wound dressings to choose from, each of which has benefits and drawbacks. An understanding of how a given dressing performs in healing a particular wound is crucial in order to determine a clinical mapping of wound dressings to wound types; such a categorization would lead to more efficient clinical decision making and better patient outcomes. This case series will evaluate the ability of a porcine-derived collagen dressing to improve healing of chronic lower-extremity wounds.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Porcine-derived collagen wound dressing | Experimental | The dressing is a sheet of collagen composed of type I collagen derived from porcine peritoneal membrane. The dressing also contains additional components from the procine extracellular matrix. The dressing is a currently marketed, cleared device in the United States indicated for the management of full- and partial-thickness wounds, including: pressure ulcers, diabetic ulcers, venous ulcers, and several other wound types. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Porcine-derived collagen wound dressing | Device | Patients who meet the inclusion criteria will be treated with porcine-derived collagen dressings. The dressing will be used in accordance with its label. After cleansing the wound, the dressing will be placed on the wound. Appropriate primary and secondary dressings will be placed over the intervention product. Patients will visit the clinic once per week to have their dressings re-applied. Wound evaluations will take place once per week with the intervention lasting up to twelve weeks. Concomitant standard of care such as compression for venous ulcers will be provided according to individual patient needs. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in wound size over a twelve week period | Baseline to 84 days |
| Measure | Description | Time Frame |
|---|---|---|
| Bates-Jensen Wound Assessment Tool score | The Bates-Jensen Wound Assessment tool score will be used to assess the wound's status throughout the study. The wound size score ranges from 0 to 5. The wound depth score ranges from 0 to 5. The wound edge score ranges from 0 to 5. The wound undermining score ranges from 0 to 5. The necrotic tissue type score ranges from 1 to 5. The necrotic tissue amount ranges from 1 to 5. The exudate type score ranges from 1 to 5. The exudate amount score ranges from 1 to 5. The skin color surrounding wound score ranges from 1 to 5. The peripheral tissue edema score ranges from 1 to 5. The peripheral tissue induration score score ranges from 1 to 5. The granulation tissue score ranges from 1 to 5. The epithelialization score ranges from 1 to 5. The total score from these sub-scores added together is used as the total BWAT score. For all sub-score values, a value of 0 or 1 is a better outcome. A score of 1 indicates the healthiest and 5 indicates the unhealthiest attribute for each characteristic. |
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Inclusion Criteria:
Exclusion Criteria:
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| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
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| Baseline to 84 days |
| Change in reported pain level: verbal numeric pain rating scale | The pain will be recorded using a verbal numeric pain rating scale from 0 to 10. A score of 0 indicates no pain and a score of 10 indicates the highest rated pain. | Baseline to 84 days |