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.
Study Type
OBSERVATIONAL
Enrollment
600
Patients already treated with a Kerecis device
MCR Health
Sarasota, Florida, United States
University Park
Sarasota, Florida, United States
Cone Health Ortho Care Greensboro
Greensboro, North Carolina, United States
Feet First Institute of Beavercreek
Beavercreek, Ohio, United States
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)
Time frame: 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)
Time frame: 12 months
Target Wound Infection
Proportion of patients who develop target wound infection
Time frame: 12 months
Complete Wound Healing
The Time in weeks to complete healing
Time frame: 12 months
Complete Wound Closure
Proportion of participants who experience complete wound closure
Time frame: 12 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
ABC Podiatry
Columbus, Ohio, United States
South Texas Skin Cancer Center
San Antonio, Texas, United States