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Enrolling by Invitation

NCT Number: NCT06384183

Kerecis Real-World Fish Skin Graft Registry

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

Enrolling by Invitation

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Key information

Conditions

Wounds Cardiovascular Diseases Diabetes Complications Diabetes Mellitus Diabetic Angiopathies Diabetic Foot Diabetic Foot Ulcer Diabetic Neuropathies Endocrine System Diseases Foot Ulcer Leg Ulcer Pressure Ulcer Skin Diseases Skin Ulcer Skin and Connective Tissue Diseases Soft Tissue Reinforcement Surgical Wound Varicose Ulcer Varicose Veins Vascular Diseases Venous Leg Ulcer Wounds and Injuries

Sex eligibility

All sexes

Study type

Observational

Primary location

MCR Health, Sarasota, Florida, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Kerecis Fish Skin Graft

Device

Patients already treated with a Kerecis device

Primary outcomes

  1. Fish Skin Graft Device Related failure

    Time frame: 12 months

    Proportion of patients with Kerecis FSG device-related failure for any reason (e.g., resulting in non-absorption or device removal)

  2. Fish Skin Graft Device related allergy

    Time frame: 12 months

    Proportion of patients with Kerecis FSG device-related allergy, hypersensitivity and/or autoimmune reaction (with or without documented auto-antibody development)

  3. Target Wound Infection

    Time frame: 12 months

    Proportion of patients who develop target wound infection

Secondary outcomes

  1. Complete Wound Healing

    Time frame: 12 months

    The Time in weeks to complete healing

  2. Complete Wound Closure

    Time frame: 12 months

    Proportion of participants who experience complete wound closure

Sponsors and collaborators

Lead sponsor

Kerecis Ltd.

Industry

Registry information

Official study title

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

Acronym: ISACOD

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
Apr 25, 2024
Registry last updated
Dec 30, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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