Pressure ulcers affect approximately 1.7 million patients in the U.S. The overall cost to the healthcare industry for treating pressure ulcers in the U.S. is estimated to exceed $7 billion, and it is well established that the cost of preventing a pressure ulcer is significantly less than its treatment. Skin breakdown is frequently seen in individuals with both permanent and short-term disabilities requiring the prolonged use of hospital beds, wheelchairs, braces, prosthetic devices and other assistive technology. Among those affected are amputees, diabetics, individuals with traumatic and atraumatic neurological disorders, and the elderly. While there are a host of extrinsic and intrinsic factors contributing to skin breakdown affecting people with disabilities, shear forces and friction are two factors known to hasten this effect. This NIH Phase I SBIR application proposes to develop and test the feasibility of a thin, flexible adhesive bandage designed to minimize shear forces and friction at the user-support interface. Feasibility analysis of the flexible adhesive bandage will include 1) developing prototypes, 2) evaluating and optimizing the manufacturing process, 3) characterizing the device for acceptable material properties, and 4) testing for in vivo friction reduction on human subjects. During Phase II, the investigators will refine the design and test its efficacy in reducing skin breakdown on residual limbs of transtibial amputees. This unique shear/friction reduction technology is designed to reduce or prevent skin breakdown, which commonly occurs at the user-support interface, and in turn improve the health and well-being of the disabled. The primary commercial application for this device is for individuals who use lower limb prostheses. Other target population groups include individuals who use wheelchairs, hospital beds, diabetic footwear and lower limb orthoses.
Thesaurus Terms: biomaterial development /preparation, biomedical equipment development, shear stress, skin irritation /irritant, surgery material /equipment, wound, wound healing amputation, biomaterial evaluation, consumable /disposable biomedical equipment, skin disorder clinical research, human subject
