Kerecis Real-World Fish Skin Graft Registry

NCT06384183 | Enrolling By Invitation FDA Device

• 1 other identifier: KS-1000
• Study Type: observational
• Target: 600
• Locations: 1 country
• Sites: 6

Brief Summary

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

Conditions

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

Outcome Measures

Primary Outcomes (3)

• Fish Skin Graft Device Related failure

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

  12 months

• Fish Skin Graft Device related allergy

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

  12 months

• Target Wound Infection

  Proportion of patients who develop target wound infection

  12 months

Secondary Outcomes (2)

• Complete Wound Healing

  12 months

• Complete Wound Closure

  12 months

Study Arms (1)

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.

Device: Kerecis Fish Skin Graft

Interventions

Kerecis Fish Skin Graft DEVICE

Patients already treated with a Kerecis device

Observational Group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Investigators will only enter previously collected clinical data from patients (all ages, demographics, and any health status) who meet all inclusion criteria and no exclusion criteria.

You may qualify if:

• 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

You may not qualify if:

• None

Sponsors & Collaborators

• Kerecis Ltd.: lead

Study Sites (6)

MCR Health

Sarasota, Florida, 34237, United States

Location

University Park

Sarasota, Florida, 34243, United States

Location

Cone Health Ortho Care Greensboro

Greensboro, North Carolina, 27401, United States

Location

Feet First Institute of Beavercreek

Beavercreek, Ohio, 45432, United States

Location

ABC Podiatry

Columbus, Ohio, 43213, United States

Location

South Texas Skin Cancer Center

San Antonio, Texas, 78215, United States

Location

MeSH Terms

Conditions

Wounds and Injuries; Pressure Ulcer; Diabetic Foot; Varicose Ulcer; Surgical Wound

Condition Hierarchy (Ancestors)

Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Diabetic Neuropathies; Varicose Veins

Study Officials

• Anne Swearingen

  Kerecis Ltd.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: OTHER
• Target Duration: 12 Months
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 22, 2024
• First Posted: April 25, 2024
• Study Start: August 7, 2024
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2027
• Last Updated: December 30, 2024

Record last verified: 2024-08

Locations

US (6)