Kerecis Real-World Fish Skin Graft Registry (ISACOD)

Kerecis Real-World Fish Skin Graft Registry - "ISACOD"

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

Study Overview

• Status: Enrolling by invitation
• Conditions: Surgical Wound; Diabetic Foot Ulcer; Venous Leg Ulcer; Pressure Ulcer; Wounds; Soft Tissue Reinforcement
• Intervention / Treatment: Device: Kerecis Fish Skin Graft

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 Type: Observational
• Enrollment (Estimated): 600

Contacts and Locations

Study Locations

• United States
  • Florida
    • Sarasota, Florida, United States, 34237
      • MCR Health
    • Sarasota, Florida, United States, 34243
      • University Park
  • North Carolina
    • Greensboro, North Carolina, United States, 27401
      • Cone Health Ortho Care Greensboro
  • Ohio
    • Beavercreek, Ohio, United States, 45432
      • Feet First Institute of Beavercreek
    • Columbus, Ohio, United States, 43213
      • ABC Podiatry
  • Texas
    • San Antonio, Texas, United States, 78215
      • South Texas Skin Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Device: Kerecis Fish Skin Graft; Patients already treated with a Kerecis device

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	12 months

Collaborators and Investigators

• Sponsor: Kerecis Ltd.
• Investigators: Principal Investigator: Anne Swearingen, Kerecis Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): August 7, 2024
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2027

Study Registration Dates

• First Submitted: April 22, 2024
• First Submitted That Met QC Criteria: April 22, 2024
• First Posted (Actual): April 25, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 27, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Diabetes Mellitus; Diabetic Angiopathies; Diabetes Complications; Skin Diseases; Skin Ulcer; Varicose Veins; Diabetic Neuropathies; Foot Diseases; Surgical Wound; Ulcer; Varicose Ulcer; Leg Ulcer; Wounds and Injuries; Diabetic Foot; Foot Ulcer; Pressure Ulcer
• Other Study ID Numbers: KS-1000

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: To be determined

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No