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Enrolling by invitation NCT06384183

Kerecis Real-World Fish Skin Graft Registry

— Observational Wounds Pressure Ulcer Diabetic Foot Ulcer Venous Leg Ulcer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Kerecis Fish Skin Graft.
Who it may be relevant to
Registry conditions: Wounds, Pressure Ulcer, Diabetic Foot Ulcer, Venous Leg Ulcer. Basic parameters: No limits · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • Device Kerecis Fish Skin Graft
    Patients already treated with a Kerecis device

Primary outcome measures

  • Fish Skin Graft Device Related failure [Time frame: 12 months]
  • Fish Skin Graft Device related allergy [Time frame: 12 months]
  • Target Wound Infection [Time frame: 12 months]
Secondary outcome measures (2)
  • Complete Wound Healing [Time frame: 12 months]
  • Complete Wound Closure [Time frame: 12 months]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Case-only

Study locations

United States · 6 centers
  • MCR Health — Sarasota
  • University Park — Sarasota
  • Cone Health Ortho Care Greensboro — Greensboro
  • Feet First Institute of Beavercreek — Beavercreek
  • ABC Podiatry — Columbus
  • South Texas Skin Cancer Center — San Antonio

Identifiers

NCT: NCT06384183 · KS-1000

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗