Kerecis Real-World Fish Skin Graft Registry

Kerecis Real-World Fish Skin Graft Registry - ISACOD

Status

Enrolling by invitation

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06384183

Acronym

ISACOD

Enrollment

600

Registered

2024-04-25

Start date

2024-08-07

Completion date

2027-06-30

Last updated

2024-12-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetic Foot Ulcer, Pressure Ulcer, Soft Tissue Reinforcement, Surgical Wound, Venous Leg Ulcer, Wounds

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.

Interventions

DEVICEKerecis Fish Skin Graft

Patients already treated with a Kerecis device

Study design

Observational model

CASE_ONLY

Time perspective

OTHER

Eligibility

Sex/Gender

ALL

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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)
Target Wound Infection	12 months	Proportion of patients who develop target wound infection

Secondary

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026