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Multi-center, observational (i.e., non-interventional), open-label, real-world Registry on the Use of Kerecis Devices
This observational (i.e., non-interventional), post-market, real-world, Registry was designed to collect, analyze, and identify relevant safety and performance outcomes for "all comers" using Kerecis devices in routine medical practice within a wide variety of United States (US) medical practice settings. These clinical data will be used at Kerecis for many purposes, which include, but are not limited to, device safety and performance evaluation as part of routine patient care and post-market clinical follow-up data commitments to regulatory authorities around the world.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Observational Group | This observational (i.e., non-interventional), post-market, real-world, Registry was designed to collect, analyze, and identify relevant safety and performance outcomes for "all comers" using Kerecis devices in routine medical practice within a wide variety of United States (US) medical practice settings. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Kerecis Fish Skin Graft | Device | Patients already treated with a Kerecis device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Fish Skin Graft Device Related failure | Proportion of patients with Kerecis FSG device-related failure for any reason (e.g., resulting in non-absorption or device removal) | 12 months |
| Fish Skin Graft Device related allergy | Proportion of patients with Kerecis FSG device-related allergy, hypersensitivity and/or autoimmune reaction (with or without documented auto-antibody development) | 12 months |
| Target Wound Infection | Proportion of patients who develop target wound infection | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Complete Wound Healing | The Time in weeks to complete healing | 12 months |
| Complete Wound Closure | Proportion of participants who experience complete wound closure |
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Inclusion Criteria:
Exclusion Criteria:
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Investigators will only enter previously collected clinical data from patients (all ages, demographics, and any health status) who meet all inclusion criteria and no exclusion criteria.
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| Name | Affiliation | Role |
|---|---|---|
| Anne Swearingen | Kerecis Ltd. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| MCR Health | Sarasota | Florida | 34237 | United States | ||
| University Park |
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| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
| D003668 | Pressure Ulcer |
| D017719 | Diabetic Foot |
| D014647 | Varicose Ulcer |
| D000072836 | Surgical Wound |
| ID | Term |
|---|---|
| D012883 | Skin Ulcer |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D003925 | Diabetic Angiopathies |
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| 12 months |
| Sarasota |
| Florida |
| 34243 |
| United States |
| Cone Health Ortho Care Greensboro | Greensboro | North Carolina | 27401 | United States |
| Feet First Institute of Beavercreek | Beavercreek | Ohio | 45432 | United States |
| ABC Podiatry | Columbus | Ohio | 43213 | United States |
| South Texas Skin Cancer Center | San Antonio | Texas | 78215 | United States |
| D014652 |
| Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D016523 | Foot Ulcer |
| D007871 | Leg Ulcer |
| D048909 | Diabetes Complications |
| D003920 | Diabetes Mellitus |
| D004700 | Endocrine System Diseases |
| D003929 | Diabetic Neuropathies |
| D014648 | Varicose Veins |