Prospective Observational Registry of Safety and Effectiveness of Acellular Fish Skin Grafts in Treatment of Cutaneous Wounds

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.