Kerecis Real-World Fish Skin Graft Registry

NCT06384183 · tracked via the Priya Life Science USA tracker

Sponsor

Kerecis Ltd.

Phase

Observational

Started

2024-08-07

Last updated

2024-12-30

Condition(s) studied

WoundsPressure UlcerDiabetic Foot UlcerVenous Leg UlcerSurgical WoundSoft Tissue Reinforcement

Investigational drug(s) / intervention(s)

Kerecis Fish Skin Graft

Kerecis Fish Skin Graft: Patients already treated with a Kerecis device

Study summary

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

Eligibility

Sex

ALL

Min age

—

Max age

—

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

Primary outcome measure(s)

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

Trial sites (6)

Facility	City	Region
MCR Health	Sarasota	Florida
University Park	Sarasota	Florida
Cone Health Ortho Care Greensboro	Greensboro	North Carolina
Feet First Institute of Beavercreek	Beavercreek	Ohio
ABC Podiatry	Columbus	Ohio
South Texas Skin Cancer Center	San Antonio	Texas

More Kerecis Ltd. trials in the USA

Evaluating Whether Intact Fish Skin Graft Can Decrease the Need for Autograft in the Treatment of Deep Partial-Thickness Burns Enrolling by invitation

Evaluating Intact Fish Skin Graft and Standard of Care Versus Standard of Care Alone in Nonhealing Venous Leg Ulcers Recruiting

Omega3 Wound Fish Skin Graft in the Treatment of DFUs Active, not recruiting

Kerecis Case Registry for SurgiBind : Soft Tissue Reinforcement Active, not recruiting

Evaluating the Durability of Closure for Venous Leg Ulcers Recruiting

Other trials for the same condition

INNOVEN: Efficacy of Porcine Placental Extracellular Matrix Plus Standard of Care (SOC) Versus SOC Alone Recruiting

Efficacy of ProgenaMatrix™ in the Management of DFUs Active, not recruiting

Geko™ Cross Therapy Registry - Wound Active, not recruiting

Prospective Case Series Evaluating the Efficacy and Safety of NeoThelium FT for Diabetic Foot Ulcers Recruiting

A Clinical Investigation to Follow the Progress of Exuding Chronic Wounds Using Mepilex® Up as the Primary Dressing. Recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06384183 on ClinicalTrials.gov ↗ ← All trials in the USA