(CR-046) Results of a Clinical Study Utilizing a Novell Contemporary Designed Medical Device for the Prevention and Treatment of Hospital Acquired Pressure Injuries

Introduction: Hospital acquired pressure injuries affect approximately 2.5 million individuals every year , in United States acute care facilities. These wounds represent an enormous burden on global healthcare from both a patient care and a budgetary perspective.

Currently, there is a gap in the landscape of devices available for prevention and treatment of these lesions. There exist many shortcomings that range from inefficient offloading to cumbersome design.

The HeelSphere is a newly patented medical device that is cost effective and efficiently provides offloading of the foot and ankle to prevent and treat these injuries.

Methods: An IRB approved user study was implemented at our community hospital setting. It involved 28 patients. Two different density devices were utilized and randomized assigned within the protocol. Patients were monitored for 72 hours to assess the effectiveness of the device. Our investigator collected various datas points, including but not limited to the offloading distance of the heel to the bed surface, as well as the position of the device with relationship to the distance from the malleoli. Observation for any skin change or reaction

secondary to the use of the device was documented as well.

Results: Based on the data collected and evaluated by our statistician, the device proved suitable for use for offloading of the foot and ankle. The HeelSphere statistically provided effective heel offloading. In 93% of the patients the device proved to be comfortable. Throughout the study, there were no reported skin conditions or medical device related tissue injuries as a direct result of the utilization of this device. Data collected from HCP indicated that the device was easy to use and provided effective offloading.Slight variation was seen between the two densities with reference to surface cracking. ( BMI relationship ).

Discussion: This newly patented device provides efficient offloading and can be effectively used in the treatment and prevention of HAPIs. Based on its global design it allows for motion of the leg. It is strapless , orange in color, easy to apply, compatible with compressors, facilitates easy observation, lightweight, allows for air flow, and has sensor capabilities .

Allowing for easier healthcare access to the wounds and allowing patients to turn in their beds without compromising offloading.The device is also vacuum packaged allowing for easier accessibility .