The proposed clinical trial is aimed at demonstrating the important role wheelchairs play in preventing pressure ulcers (bed sores). Although most pressure ulcers can be prevented, they are common in nursing home settings because their causes are difficult to identify. This clinical trial will guide practitioners toward improving preventive care practices by demonstrating how to effectively apply wheelchair and seat cushion technology.
Pressure ulcers are a significant healthcare problem for the growing number of nursing home residents in the United States and around the world. Pressure ulcers diminish quality of life, exact a devastating loss of function, increase the risk of death in geriatric populations and raise healthcare costs. Costs for the management of pressure ulcers in the US likely exceeds $6.4 billion annually, with a prevalence of approximately 12% in the high risk LTC population. A previous clinical trial at the University of Pittsburgh studied the effects of seat cushions on pressure ulcer incidence and found that when a skin protection seat cushion is used with a properly fitted wheelchair there is a significant reduction in incidence. The data led the investigators to question whether having a properly fitted wheelchair also has a significant effect on pressure ulcer incidence. This clinical trial investigate this question by randomizing subjects into a control group that receives a skin protection cushion and wheelchair training for use in their facility supplied wheelchair, or a treatment group that receives a skin protection cushion, wheelchair training and a new custom-fitted wheelchair. We expect that the treatment group will have a lower incidence of pressure ulcers.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
258
Seating and wheeled mobility assessment and fitting of a lightweight wheelchair
Seating assessment and provision of a cushion meeting CMS code for Skin Protection wheelchair cushion
University of Pittsburgh
Pittsburgh, Pennsylvania, United States
Incidence of a Sitting-induced Pressure Ulcer
Skin assessments for incidence of sitting-induced pressure ulcers will occur once per week until the occurrence of a pressure ulcer or 182 days
Time frame: 182 days
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