What are pressure ulcers?
There are two types of pressure sores that develop in people with reduced mobility and sensation: those on the surface of the skin, which break through skin, fat or muscle all the way to the bone, and the other, which develops at the interfaces of bone and muscle and is only detected when extensive damage exhibits on the surface of the skin. This second level of pressure ulcer in particular can cause infection, sepsis, organ failure and death. In the United States pressure ulcers kill more than 60,000 people every year, making them one of the 10 leading causes of death.
Mushahwar and her team also found that turning a patient is not as effective for prevention as active contraction of that patient’s muscles, so they came up with a solution encompassing this new thinking on pressure ulcers: Smart-e-Pants™. The close-fitting shorts contain pads that deliver a minor electrical stimulus every 10 minutes to cause muscle contraction.
Phase 1 clinical trials, in which 70 patients used the device for anywhere from one month to 16 months in settings ranging from intensive care to home care, are already complete. Both patients and practitioners found the device very safe and feasible for everyday use, and none of the patients developed pressure ulcers.
The Phase 2, multi-centre clinical trials will determine the innovation’s effectiveness and is on schedule. In the meantime, Mushahwar and her team are addressing the necessary regulatory approvals with Health Canada and the U.S. Food and Drug Administration to start selling the devices. Work is also expected to begin soon to demonstrate the cost-effectiveness of the pants for the health-care system through a partnership between Alberta Innovates – Health Solutions and Alberta Health Services. The upshot? Smart-e-Pants™ are expected to be available for sale in 2015, with the potential to improve, even save, the lives of millions of people around the world.
They will also save billions of dollars in health spending, says Mushahwar, citing the expertise provided in collaboration as one of the reasons why the product commercialization has been possible.
Dr. K. Ming Chan, a professor in the Division of Physical Medicine & Rehabilitation in the Faculty of Medicine & Dentistry, has been working as clinical lead on the co-ordination of the clinical testing in different health-care settings in Edmonton and Calgary for the last five years. “An important next step is to formally evaluate the efficacy of the Smart-e-Pants™ in preventing deep pressure ulcers and to establish the health-care savings that such a treatment would be able to achieve,” he says.