Kerecis Real-World Fish Skin Graft Registry

• Conditions: Wounds; Diabetic Foot Ulcer; Surgical Wound; Soft Tissue Reinforcement; Pressure Ulcer; Venous Leg Ulcer
• Interventions: Device: Kerecis Fish Skin Graft

• Registration Number: NCT06384183
• Lead Sponsor: Kerecis Ltd.

Brief Summary

Multi-center, observational (i.e., non-interventional), open-label, real-world Registry on the Use of Kerecis Devices

Detailed Description

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 Timeline

• Study First Submitted: 2024-04-22
• Study First Submitted QC: 2024-04-22
• Study First Posted: 2024-04-25
• Status Verified: 2024-08
• Study Start: 2024-08-07
• Last Update Submitted: 2024-12-27
• Last Update Posted: 2024-12-30
• Primary Completion: 2026-06
• Study Completion: 2027-06

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 600

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Observational Group	Kerecis Fish Skin Graft	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.

Primary Outcome Measures

Name	Time	Method
Target Wound Infection	12 months	Proportion of patients who develop target wound infection
Fish Skin Graft Device Related failure	12 months	Proportion of patients with Kerecis FSG device-related failure for any reason (e.g., resulting in non-absorption or device removal)
Fish Skin Graft Device related allergy	12 months	Proportion of patients with Kerecis FSG device-related allergy, hypersensitivity and/or autoimmune reaction (with or without documented auto-antibody development)

Secondary Outcome Measures

Name	Time	Method
Complete Wound Closure	12 months	Proportion of participants who experience complete wound closure
Complete Wound Healing	12 months	The Time in weeks to complete healing

Trial Locations

Locations (6)

South Texas Skin Cancer Center; 🇺🇸 San Antonio, Texas, United States

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

ABC Podiatry; 🇺🇸 Columbus, Ohio, United States