Kerecis Real-World Fish Skin Graft Registry (ISACOD)

Kerecis

Status: Invitation-only

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

Treatments: Device: Kerecis Fish Skin Graft

Study type: Observational

Funder types: Industry

Identifiers

NCT06384183

KS-1000

Details and patient eligibility

About

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

Full 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.

Enrollment: 600 estimated patients

Sex: All

Volunteers: No 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

Trial design

600 participants in 1 patient group

Observational Group

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.

Treatment:

Device: Kerecis Fish Skin Graft