Kerecis Real-World Fish Skin Graft Registry

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Total Enrollment

600 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-08-07

Study Completion Date

2027-06-30

Brief Summary

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

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Detailed Description

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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.

Conditions

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

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

OTHER

Study Groups

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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.

Kerecis Fish Skin Graft

Intervention Type DEVICE

Patients already treated with a Kerecis device

Interventions

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Kerecis Fish Skin Graft

Patients already treated with a Kerecis device

Intervention Type DEVICE

Eligibility Criteria

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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