Design of Clinical Case Registry Database for Patients with Chronic Wounds

Introduction The number of people with diabetes in the world has risen from 108 million in 1980 to 422 million in 2014. 25% of the diabetic population will eventually develop chronic leg wounds that often lead to amputation. Chronic wounds are defined as wounds that do not heal after 4 weeks of standard treatment. The best way to heal chronic wounds is by skin transplant from the patient’s hip. However, the transplant is not always successful, leaving the patient with two wounds instead of one. Kerecis Omega3 Wound is intact Omega3 rich fish skin that has been developed as a substitute for human skin transplants. The quality of patient data collection is often lacking in hospitals and other health centers, hence there is a need for a secure clinical case registry database (CCRD) that can be used to collect clinical data from multiple centers. Objective The objective of this project is to create and implement a CCRD for chronic wounds treated with Kerecis Omega3 that will allow for quantitative statistical analysis of clinical data, efficacy and clinical data. The CCRD will serve as a data collection tool to help evaluate real world efficacy and safety of Kerecis Omega3 for a variety of wound types. Methods The database was designed and programmed using the IBM Domino legacy system. Two patient data management systems were investigated in detail prior to the initial design of the CCRD. These are the Electronic Health Records software WoundExpert by Net Health and the Medrio Electronic Data Capture system. Parameters to be included in the CCRD were chosen in collaboration with practicing medical doctors and the scientific advisors at Kerecis. The CCRD was designed to allow for descriptive statistical analysis of the collected data, including gender, age, wound etiology, wound severity, wound size, wound age, diagnosis, co-morbidities, pain, adverse events, time to heal and number of Kerecis Omega3 Wound applications. Results A functioning database for data collection has been developed and implemented for real-world data entry at three facilities. As a part of the development process, three medical doctors tested the database by registering 3-5 real cases and were satisfied with the design of the database. The CCRD allows for descriptive statistical analysis of the collected data, including wound etiology, wound size, wound age, diagnosis, co-morbidities, adverse events, time to heal and number of applications. An abstract relating to the project was written and submitted to the SAWC Fall science panel for review. Conclusion and Discussion The results from the evaluations from the medical doctors on the usability of the CCRD and subsequently the statistical analysis, demonstrated the utility of the database. The results showed that the CCRD is useful for collecting clinical data which can be easily extracted to a CSV format that can be imported into the statistical computing software R, for statistical analyses