Clinical Trial Details
— Status: Recruiting
Administrative data
NCT number |
NCT05898698 |
Other study ID # |
KS-0790 |
Secondary ID |
|
Status |
Recruiting |
Phase |
|
First received |
|
Last updated |
|
Start date |
March 17, 2023 |
Est. completion date |
December 17, 2025 |
Study information
Verified date |
April 2024 |
Source |
Kerecis Ltd. |
Contact |
Colleen Brennan, MPH,BSN |
Phone |
2012204700 |
Email |
cbrennan[@]kerecis.com |
Is FDA regulated |
No |
Health authority |
|
Study type |
Observational [Patient Registry]
|
Clinical Trial Summary
This is a post-market, observational and non-interventional registry to collect real-world
data in diverse clinical settings and wound applications of acellular fish skin graft (FSG).
The registry will be multi-center , target a wide patient population and a variety of wounds
to document the quality of wound care, patient outcomes, safety and long-term results.
Description:
Introduction: This registry will be conducted according to US standards of Good Clinical
Practice as adopted by the Food and Drug Administration, associated Federal regulations and
applicable institutional research policies and procedures. This study has been approved by a
central IRB, WCG IRB in April 2023.
Registry Objectives: The overall objective of the registry is to collect quality and safety
data to assess the efficacy of the FSG in treatment of acute and chronic wounds. The ultimate
goal of the registry is to enhance quality of care, patient outcomes and establish a resource
to facilitate the use of FSG in treatment of acute and chronic wounds.
Primary Objective: The main purpose of the registry is to evaluate the safety and long-term
effectiveness of acellular fish skin grafts in treatment of acute and chronic wounds in a
real world setting.
Secondary Objective: To evaluate the clinical and financial benefits of FSG in terms of
quality of healing, pain and treatment cost.
Research Design: This registry will prospectively collect data from treatment and follow-up
of patients who have undergone procedures where wounds are treated with Kerecis FSG. The
registry is a non-experiment, multi-center , single arm, open label study to determine real
world long-term safety and quality of Kerecis FSG. The study will not be interventional,
de-indentified, HIPAA compliant data will only be collected on patients already scheduled to
receive the Kerecis product. Subjects will be enrolled as they are scheduled to receive FSG
for treatment of their index wound. Subjects will complete follow up as scheduled by their
physician and their data will be documented at weekly follow-ups through week 32. Clinical
improvement will be collected through case report forms (CRF) at each time point. Subjects
will be followed for the 32 weeks but if the Index wound heals before that time , there will
be a Healing Confirmation Visit (HCV) 2 weeks after to confirm the Index wound is still
healed. If Index wound is not healed at the HCV then the subject will continue to next weekly
visit. Index wound assessments will be captured digitally. The depth of the index wound will
be collected manually by using a sterilized cotton swab placed in the deepest part of the
wound and documenting that measurement. One year form the procedure, patients will receive a
survey to evaluate their overall experience and provide any feedback. Overall, the registry
is prospective except information regarding patient medical history can be collected
retrospectively.
Registry Procedures: Specific Training: Prior to subject enrollment , the Sponsor will
initiate in person training with participating sites to provide training to the physicians
and their staff about the protocol, registry procedures and data entry. The sponsor will
implement a number of strategies to ensure to ensure the quality, consistency and
interpretability of data recorded. Training, education and ongoing liason with participating
sites will be provided to support high quality data collection.
Data Management and Quality Plan: Data De-identification: Subjects enroll in the registry
will be assigned a unique subject identification number. This number will consist of ten
characters for the registry protocol number, three digits for a site number and four digits
for a sequentially assigned subject number (i.e.,0001, 0002 etc.) Data confidentiality,
storage, and Retention: All clinicians and related medical staff involved in looking after
patients during the study are bound by medical confidentiality and are obliged to comply with
data protection follow all Health Information Portability and Accountability Act of 1996
(HIPAA) and Protected Health Information (PHI). Data will be collected in a CRF and entered
into secure, web-based portal databases. The databases are housed and managed in an
International Organization for Standardization (ISO) 27001 certified environment. Only
authorized users and site administrators can see site wide data. Surgeon users can only see
their procedure. The registry will contain built-in exporting function to enable data
extraction by participating sites to help clinicians review their practice and improve the
services. The paper form CRF will be stored in a locked file cabinet at the participating
sites and will be shredded after 7 years post completion of the registry.
Data Quality: The registry will implement several strategies to maintain data quality and
consistency such as routine cleaning, quality check and periodic feedback. Training,
education and ongoing liason with participating sites will be provided to supporting high
quality data collection.