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Funding
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This prospective, randomized pilot study compares the use of a xenograft with PRP to a xenograft alone for chronic, nonhealing wounds.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Xenograft only | No Intervention | The Kerecis® xenograft (Kerecis® Omega3 MariGen) will be applied without the application of PRP. | |
| Xenograft and PRP | Experimental | The Kerecis® xenograft (Kerecis® Omega3 MariGen) will be applied with the application of PRP. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Platelet Rich Plasma | Other | Platelet rich plasma will be applied to assess rate of wound healing. |
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| Measure | Description | Time Frame |
|---|---|---|
| Time to wound being deemed healed or 6 months | Assessed by time, surface area of wound, wound volume and relative surface size | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Wound quality of life | The Wound-QoL-14 questionnaire on quality of life with chronic wounds will be used to assess changes in score prior to initial application of xenograft or xenograft/PRP to time of wound healing or 6 months, whichever comes first. | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St. Elizabeth Healthcare Edgewood | Edgewood | Kentucky | 41017 | United States |
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This study will be a 1:1 randomized controlled trial with parallel group assignment.
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