Kerecis Real-World Fish Skin Graft Registry

Launched by KERECIS LTD. · Apr 22, 2024

Keywords

ClinConnect Summary

This is a real-world, non-interventional registry called the Kerecis Real-World Fish Skin Graft Registry (ISACOD). It looks at how well the Kerecis Fish Skin Graft device works in everyday medical practice for various wounds—like diabetic foot ulcers, pressure ulcers, venous leg ulcers, surgical wounds, and other soft-tissue wounds—over about a year. Because it’s observational, it does not assign treatments or change how care is given; instead, it collects information from patients who have already been treated with the device to understand safety and how wounds heal in real-life settings.

Who can be included? Any patient who gives informed consent, of any age or sex, and who has at least one wound treated with a Kerecis device within the month before enrollment. There are no listed exclusion criteria. The study plans to enroll about 600 people at multiple centers across the United States. Participants will have data collected during routine care for up to 12 months, focusing on whether the device causes problems or allergies, whether the wound gets infected, how long it takes to heal, and how often wounds completely close. The registry is sponsored by Kerecis Ltd., and results are not yet available.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Provided informed consent
• • Has at least one target wound treated with a Kerecis device according to physician medical judgement within one calendar month prior to the registry enrollment date
• Exclusion Criteria:
• • None